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Peter Stalmans - One of the best experts on this subject based on the ideXlab platform.

  • phase i trial on robot assisted retinal vein cannulation with Ocriplasmin infusion for central retinal vein occlusion
    Acta Ophthalmologica, 2021
    Co-Authors: Koen Willekens, Jean H. M. Feyen, Andy Gijbels, Jonas Smits, Laurent Schoevaerdts, Johan Blanckaert, Dominiek Reynaerts, Peter Stalmans
    Abstract:

    PURPOSE To evaluate the safety and feasibility of robot-assisted retinal vein cannulation with Ocriplasmin infusion for central retinal vein occlusion. METHODS Prospective phase I trial including four patients suffering from central retinal vein occlusion (CRVO). Diagnosis was confirmed by preoperative fluo-angiography and followed by a standard three-port pars plana vitrectomy. Afterwards, a custom-built microneedle was inserted into a branch retinal vein with robotic assistance and infusion of Ocriplasmin started. Primary outcomes were the occurrence of intra-operative complications and success of cannulation. Secondary outcomes were change in visual acuity, central macular thickness (CMT) and venous filling times (VFT) during fluo-angiography two weeks after the intervention. RESULTS Cannulation with infusion of Ocriplasmin was successful in all four eyes with a mean total infusion time of 355 ± 204 seconds (range 120-600 seconds). Best corrected visual acuity (BCVA) remained counting fingers (CF) in case 3 and 4, increased in case 1 from CF to 0.9LogMAR and decreased in case 2 from 0.4 to 1.3 LogMAR. CMT and VFT both showed a trend towards significant decrease comparing preoperative measurements with two weeks postintervention (1061 ± 541 μm versus 477 ± 376 μm, p = 0.068) and 24 ll 4 seconds versus 15 ± 1 seconds, p = 0.068, respectively). In one eye a needle tip broke and could be removed with an endoforceps. There were no other intervention-related complications. CONCLUSION Robot-assisted retinal vein cannulation is feasible and safe. Local intravenous infusion with Ocriplasmin led to an improved retinal circulation.

  • assessment of anatomical and functional outcomes with Ocriplasmin treatment in patients with vitreomacular traction with or without macular holes results of oviid 1 trial
    Retina-the Journal of Retinal and Vitreous Diseases, 2019
    Co-Authors: Ramin Tadayoni, Frank G Holz, Christophe Zech, Xin Liu, Claudio Spera, Peter Stalmans
    Abstract:

    Purpose To evaluate the anatomical and functional outcomes with Ocriplasmin in patients with vitreomacular traction (VMT) with or without macular hole (MH). Methods In a Phase 4, multicenter, single-arm, open-label study, eligible patients (VMT with focal adhesion, without epiretinal membrane, and with MH ≤400 µm [if present]) received a single intravitreal injection of Ocriplasmin. Nonsurgical resolution of VMT (Day 28 [primary endpoint]), best-corrected visual acuity, MH closure, vitrectomy rate, and safety were assessed through Day 180. Results Overall, 466 patients were included in the full analysis set, of whom 47.4% had VMT resolution by Day 28; resolution rates in patients with VMT without MH, VMT with MH ≤250 µm, and VMT with MH >250 to ≤400 µm were 43.4%, 68.6%, and 62.7%, respectively. Macular hole closure was higher in eyes with VMT and MH ≤250 µm (57.1%) than in eyes with VMT and MH >250 to ≤400 µm (27.5%) at Day 28. Overall, 30.8% of patients with VMT resolution gained ≥10 letters in best-corrected visual acuity at Day 180. Adverse events were consistent with the known safety profile of Ocriplasmin. Conclusion Ocriplasmin is effective for resolution of VMT without or with MH (≤400 μm); treatment outcomes can be optimized with patient selection.

  • improved efficacy of Ocriplasmin for vitreomacular traction release and transient changes in optic disk morphology
    Retina-the Journal of Retinal and Vitreous Diseases, 2015
    Co-Authors: Koen Willekens, Evelien Vandewalle, Ingeborg Stalmans, Luis Abegao Pinto, Peter Stalmans
    Abstract:

    Purpose To determine the efficacy and safety of Ocriplasmin for vitreomacular traction (VMT) resolution and to study changes in optic disk and peripapillary region. Methods Retrospective, single-center, observational case series. In 38 eyes with VMT (10 with concomitant full-thickness macular hole), determined by optical coherence tomography, a single intravitreal injection of Ocriplasmin was administered. Baseline ocular characteristics included the presence/absence of epiretinal membrane, lens status, and vitreomacular adhesion size. Spectral domain optical coherence tomography and Heidelberg retinal tomography were performed at baseline and follow-up visits. Results A total of 71.1% of eyes treated with Ocriplasmin had VMT resolution, improving to 83.9% after applying MIVI-TRUST selection criteria. A total of 90% of eyes with full-thickness macular hole showed VMT resolution, with 40% of those achieving full-thickness macular hole closure. Subretinal fluid in the macular region was observed in 36.8% of eyes 1 day after injection, and all cleared spontaneously by Day 42. A significant difference was observed in cup/disk area ratio between patients who achieved VMT resolution and patients who did not. Conclusion Careful patient selection improves Ocriplasmin efficacy. Transient optic disk morphology changes such as decreased cup/disk area ratio may occur in patients without VMT resolution.

  • early evolution of the vitreomacular interface and clinical efficacy after Ocriplasmin injection for symptomatic vitreomacular adhesion
    Ophthalmic Surgery and Lasers, 2015
    Co-Authors: Jacob C Meyer, Peter Stalmans, Elias Reichel, Gaurav K Shah, Kevin J Blinder, Nadia K Waheed, Michael Singer, Asheesh Tewari
    Abstract:

    BACKGROUND AND OBJECTIVE To determine early evolution of the vitreomacular interface and clinical efficacy and safety profile after Ocriplasmin treatment. PATIENTS AND METHODS Retrospective, multicenter, observational case series. Patients with vitreomacular adhesion (VMA) confirmed on optical coherence tomography (OCT) received a single intravitreal Ocriplasmin injection. Changes in the vitreomacular interface were evaluated by spectral-domain OCT. Adverse events were monitored at all visits. RESULTS Of 22 patients treated with Ocriplasmin, 14 (64%) had VMA resolution, with six (43%) achieving VMA release within the first week. Eight patients (36%) showed improvement in visual acuity (VA) of at least two Snellen lines. Rate of VMA resolution was 79% for VA less than 20/40 and 38% for VA of 20/40 or greater. Safety findings include changes in the ellipsoid layer (n = 3) and transient increases in subretinal fluid (n = 6). CONCLUSION Ocriplasmin was effective for VMA resolution, with a rapid onset of action. Patients with worse baseline VA showed a higher VMA resolution rate.

  • efficacy of intravitreal Ocriplasmin for treatment of vitreomacular adhesion subgroup analyses from two randomized trials
    Ophthalmology, 2015
    Co-Authors: Julia A Haller, Peter Stalmans, Aniz Girach, Matthew S Benz, Glenn J Jaffe, Arnd Gandorfer, Anselm Kampik, Stephen Pakola, Cynthia A Toth
    Abstract:

    Purpose To evaluate the efficacy of a single intravitreal injection of Ocriplasmin 125 μg across relevant subpopulations of patients with symptomatic vitreomacular adhesion (VMA)/vitreomacular traction (VMT), including when associated with macular hole. Design Two multicenter, randomized, placebo-controlled, double-masked, 6-month studies. Participants A total of 652 randomized patients (464 receiving Ocriplasmin; 188 receiving placebo). Methods A single intravitreal injection of Ocriplasmin 125 μg or placebo in the study eye. Main Outcome Measures Prespecified subgroup analyses were conducted to evaluate the effects on the proportion of patients with nonsurgical resolution of focal VMA at day 28, nonsurgical full-thickness macular hole (FTMH) closure at month 6, and categoric improvement in best-corrected visual acuity (BCVA) at month 6. Results Resolution of VMA at day 28 was achieved more often in younger patients ( Conclusions Subgroup analyses confirmed the positive effect of Ocriplasmin across relevant subpopulations.

Peter K Kaiser - One of the best experts on this subject based on the ideXlab platform.

  • Ocriplasmin treatment leads to symptomatic vitreomacular adhesion vitreomacular traction resolution in the real world setting the phase iv orbit study
    Ophthalmology Retina, 2019
    Co-Authors: Arshad M Khanani, Peter K Kaiser, Petra Kozma, Jay S Duker, Daniel F Rosberger, Jeffrey S Heier, Brian C Joondeph, Mathew Maccumber, David S Boyer, Dante J Pieramici
    Abstract:

    Purpose To evaluate clinical outcomes and safety up to 12 months after Ocriplasmin injection for the treatment of patients with symptomatic vitreomacular adhesion (VMA)/vitreomacular traction (VMT) in a real-world setting. Design The Phase IV Ocriplasmin Research to Better Inform Treatment (ORBIT) trial ( NCT02079883 ) was a Phase IV multicenter, prospective, observational study. Participants Patients aged ≥18 years with symptomatic VMA/VMT treated with Ocriplasmin. Methods Patients received a single 0.125 mg intravitreal injection of Ocriplasmin. All assessments and treatment decisions were at the discretion of the treating physician. Spectral-domain OCT (SD-OCT) images were analyzed by an independent central reading center (CRC). All enrolled patients were included in demographic, baseline characteristics, and safety analyses. Patients with symptomatic VMA/VMT at baseline determined by CRC were included in baseline ocular characteristics and efficacy analyses. Main Outcome Measures Clinical outcomes were measured up to 12 months and included resolution of symptomatic VMA, closure of full-thickness macular hole (FTMH), mean change from baseline in best-corrected visual acuity (BCVA), incidence of vitrectomy, and time to first vitrectomy. Safety outcomes included the incidence and timing of onset of adverse drug reactions (ADRs). Results Of the 539 patients enrolled, 480 were determined to have symptomatic VMA/VMT at baseline post-CRC assessment. After treatment with Ocriplasmin, the rate of VMA/VMT resolution was 45.8% (95% confidence interval [CI], 41.3–50.4) at month 1 and 59% (95% CI, 54.4–63.4) at months 10 to 12. The rate of FTMH closure was 30.5% (95% CI, 22.4–39.7) at month 1 and 32.2% (95% CI, 23.9–41.4) at months 10 to 12. Mean (standard deviation) change from baseline in BCVA was 1.5 (11.19) letters at month 1 and 5.2 (13.60) letters at months 10 to 12. Vitrectomy was performed in 28.5% of patients, with a median time to vitrectomy of 63 days. Adverse drug reactions were reported by 30.6% of patients; 5.2% experienced a serious ADR. Conclusions Results from the ORBIT study demonstrate that treatment with Ocriplasmin is effective and well tolerated in patients with symptomatic VMA/VMT in a real-world setting. The percentage of patients with VMA/VMT resolution at month 1 was higher than previously reported in well-controlled clinical trials. No new safety signals were identified.

  • budget impact analysis of Ocriplasmin for the treatment of symptomatic vitreomacular adhesion in the usa
    Journal of Comparative Effectiveness Research, 2018
    Co-Authors: Pravin U Dugel, Julia A Haller, Peter K Kaiser, Renee Jg Arnold
    Abstract:

    BACKGROUND Vitreomacular traction (VMT) treatment options include watchful waiting, vitrectomy and intravitreal Ocriplasmin injection (Jetrea®). This analysis used results from the recently completed OASIS randomized clinical trial to evaluate the 2-year budget impact of Ocriplasmin injection availability for treatment of Stage I or II VMT without epiretinal membrane formation in a modeled US health plan. MATERIALS & METHODS VMT prevalence, treatment patterns and disease resolution rates were from literature, a US retinal-specialist survey and the OASIS trial. Medicare payment rates were applied and a national scenario analysis was conducted. RESULTS With Ocriplasmin available, vitrectomy use and complications-related costs decreased. Budget impact of Ocriplasmin to the health plan was US$143,599 over 2 years or US$0.0060 per-member per-month. CONCLUSION Ocriplasmin was projected to be minimally cost-additive at US$0.0060 per-member per-month over 2 years.

  • improvement in patient reported visual function after Ocriplasmin for vitreomacular adhesion results of the microplasmin for intravitreous injection traction release without surgical treatment mivi trust trials
    JAMA Ophthalmology, 2015
    Co-Authors: Rohit Varma, Julia A Haller, Peter K Kaiser
    Abstract:

    Importance The impact of vitreomacular adhesion (VMA) resolution on patient-reported visual function in symptomatic VMA/vitreomacular traction (VMT) has not yet been documented, to our knowledge. Objective To determine the impact of intravitreal Ocriplasmin on patient-reported visual function using the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) during a 6-month follow-up in patients with symptomatic VMA. Design, Setting, and Participants Two multicenter, randomized, masked, phase 3 clinical trials (studies TG-MV-006 [between December 2008 and April 2010] and TG-MV-007 [between December 2008 and July 2010]) at clinic-based centers in the United States and Europe. A total of 652 patients with symptomatic VMA/VMT, including when associated with a macular hole 400 μm or smaller, were studied. Analysis was by intent-to-treat population and performed in May 2013. Interventions Patients with symptomatic VMA/VMT were randomly assigned (2:1 or 3:1 in study TG-MV-006 and study TG-MV-007, respectively) to receive a single intravitreal injection of Ocriplasmin, 125 μg, or placebo-injected vehicle (placebo). The NEI VFQ-25 was administered at baseline and 6 months following Ocriplasmin injection. Main Outcomes and Measures Mean changes between baseline and 6-month follow-up NEI VFQ-25 composite and subscale scores and the proportion of patients with a clinically meaningful change (≥5 points) in scores. Results Across the 2 studies, 464 patients received Ocriplasmin and 188 received placebo. At 6 months, the Ocriplasmin group reported greater mean improvements from baseline in the NEI VFQ-25 composite score than the placebo group (mean change, 3.4 vs 0.7, respectively; P  = .005). Improvements were also noted in subscale scores, with the following respective mean changes for the Ocriplasmin vs placebo groups: vision-related dependency, 1.7 vs −2.1 ( P  = .009); driving difficulty, 2.7 vs −1.5 ( P  = .03); distance vision activities, 4.1 vs 0.8 ( P  = .03); and general vision, 6.1 vs 2.1 ( P  = .003). A higher proportion of the Ocriplasmin group had a clinically meaningful (≥5-point) improvement in NEI VFQ-25 composite score from baseline than the placebo group (36.0% vs 27.2%, respectively; P  = .03). Fewer Ocriplasmin-treated patients had a clinically meaningful worsening in their visual function than the placebo group (15.0% vs 24.3%, respectively; P  = .005). Changes in NEI VFQ-25 composite score and various subscale scores were observed in Ocriplasmin-treated patients who achieved VMA resolution at day 28. Conclusions and Relevance Ocriplasmin produces clinically meaningful improvement in patient-reported visual function in symptomatic VMA/VMT. Trial Registration clinicaltrials.gov Identifiers:NCT00781859andNCT00798317

  • improvement in patient reported visual function after Ocriplasmin for vitreomacular adhesion results of the microplasmin for intravitreous injection traction release without surgical treatment mivi trust trials
    JAMA Ophthalmology, 2015
    Co-Authors: Rohit Varma, Julia A Haller, Peter K Kaiser
    Abstract:

    Importance The impact of vitreomacular adhesion (VMA) resolution on patient-reported visual function in symptomatic VMA/vitreomacular traction (VMT) has not yet been documented, to our knowledge. Objective To determine the impact of intravitreal Ocriplasmin on patient-reported visual function using the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) during a 6-month follow-up in patients with symptomatic VMA. Design, Setting, and Participants Two multicenter, randomized, masked, phase 3 clinical trials (studies TG-MV-006 [between December 2008 and April 2010] and TG-MV-007 [between December 2008 and July 2010]) at clinic-based centers in the United States and Europe. A total of 652 patients with symptomatic VMA/VMT, including when associated with a macular hole 400 μm or smaller, were studied. Analysis was by intent-to-treat population and performed in May 2013. Interventions Patients with symptomatic VMA/VMT were randomly assigned (2:1 or 3:1 in study TG-MV-006 and study TG-MV-007, respectively) to receive a single intravitreal injection of Ocriplasmin, 125 μg, or placebo-injected vehicle (placebo). The NEI VFQ-25 was administered at baseline and 6 months following Ocriplasmin injection. Main Outcomes and Measures Mean changes between baseline and 6-month follow-up NEI VFQ-25 composite and subscale scores and the proportion of patients with a clinically meaningful change (≥5 points) in scores. Results Across the 2 studies, 464 patients received Ocriplasmin and 188 received placebo. At 6 months, the Ocriplasmin group reported greater mean improvements from baseline in the NEI VFQ-25 composite score than the placebo group (mean change, 3.4 vs 0.7, respectively; P  = .005). Improvements were also noted in subscale scores, with the following respective mean changes for the Ocriplasmin vs placebo groups: vision-related dependency, 1.7 vs −2.1 ( P  = .009); driving difficulty, 2.7 vs −1.5 ( P  = .03); distance vision activities, 4.1 vs 0.8 ( P  = .03); and general vision, 6.1 vs 2.1 ( P  = .003). A higher proportion of the Ocriplasmin group had a clinically meaningful (≥5-point) improvement in NEI VFQ-25 composite score from baseline than the placebo group (36.0% vs 27.2%, respectively; P  = .03). Fewer Ocriplasmin-treated patients had a clinically meaningful worsening in their visual function than the placebo group (15.0% vs 24.3%, respectively; P  = .005). Changes in NEI VFQ-25 composite score and various subscale scores were observed in Ocriplasmin-treated patients who achieved VMA resolution at day 28. Conclusions and Relevance Ocriplasmin produces clinically meaningful improvement in patient-reported visual function in symptomatic VMA/VMT. Trial Registration clinicaltrials.gov Identifiers:NCT00781859andNCT00798317

  • safety profile of Ocriplasmin for the pharmacologic treatment of symptomatic vitreomacular adhesion traction
    Retina-the Journal of Retinal and Vitreous Diseases, 2015
    Co-Authors: Peter K Kaiser, Baruch D. Kuppermann, Aniz Girach, Anselm Kampik, Stanislao Rizzo, Robert C Sergott
    Abstract:

    Purpose:To report the safety of intravitreal Ocriplasmin injection based on 2 Phase 3 clinical trials in patients with symptomatic vitreomacular adhesion/vitreomacular traction, including when associated with full-thickness macular holes.Methods:Safety analyses were based on 2 completed Phase 3 stud

Justis P Ehlers - One of the best experts on this subject based on the ideXlab platform.

  • longitudinal ellipsoid zone and subretinal fluid mapping following Ocriplasmin injection in the prospective observational orbit trial
    British Journal of Ophthalmology, 2020
    Co-Authors: Jeremy A Lavine, Sunil K Srivastava, Neeley Dukles, Jamie Reese, Justis P Ehlers
    Abstract:

    Background Ocriplasmin is approved for the treatment of symptomatic vitreomacular traction (VMT). However, several retrospective reports have identified ellipsoid zone (EZ) alterations on spectral domain optical coherence tomography (SDOCT) after Ocriplasmin injection. This report quantitatively analysed outer retinal changes after intravitreal Ocriplasmin. Methods Ocriplasmin Research to Better Inform Treatment is a prospective, observational phase IV clinical study where subjects received a single intravitreal injection of Ocriplasmin for symptomatic VMT. Macular cube scans were imported into a semiautomated EZ mapping and fluid feature extraction software for SDOCT analysis. Change in visual acuity, VMT release, macular hole (MH) closure, EZ integrity/volume and subretinal fluid (SRF) volume on SDOCT macular cube scans were recorded and analysed. Results This analysis included 55 participants with 6 months of follow-up. Intravitreal Ocriplasmin injection caused VMT release in 67% and MH closure in 82% of participants. Visual acuity improved by 4.5 letters (p Conclusion Ocriplasmin treatment resulted in VMT release, MH closure and visual acuity gains in a significant portion of eyes. EZ volume was significantly reduced at week 1, but recovered to baseline levels by final follow-up and was not associated with final visual acuity.

  • ellipsoid zone mapping and outer retinal characterization after intravitreal Ocriplasmin
    Retina-the Journal of Retinal and Vitreous Diseases, 2016
    Co-Authors: Yuji Itoh, Justis P Ehlers
    Abstract:

    PURPOSE To assess outer retinal architectural alterations after intravitreal Ocriplasmin with a novel automated ellipsoid zone (EZ) mapping algorithm. METHODS A single-center, retrospective, consecutive case series of image analysis was performed. Quantitative assessment of EZ status imaged with spectral-domain optical coherence tomography was performed before and after single intravitreal injection of 0.125 mg of Ocriplasmin (Jetrea, Thrombogenics). A novel EZ mapping algorithm was used to assess the EZ retinal pigment epithelium (RPE) central area, EZ-RPE macular volume, and en face EZ integrity based on the percentage of sampling areas with 20 μm or greater EZ-RPE thickness. Longitudinal assessment of these changes with custom optical coherence tomography reading software was completed. Clinical characteristics and outcomes were compared with these retinal changes. RESULTS Nineteen eyes were included in this study. The retinal volume between EZ and RPE was significantly reduced at 1 week after Ocriplasmin (P = 0.0036). Seven of 19 patients (36.8%) complained of color abnormalities or brightness reduction after injection. All of these seven patients had increased subretinal fluid after Ocriplasmin and EZ attenuation. The EZ-RPE volume was reduced at 1 week (P = 0.0036), 1 month (P = 0.015) after Ocriplasmin, and restored by 3 months. The area with EZ-RPE thickness below 20 μm was increased at 1 week (P = 0.046) after Ocriplasmin and recovered with time. CONCLUSION Mapping of EZ is feasible to assess EZ-RPE volume and overall EZ integrity with en face thickness mapping. Alterations in EZ occur in a significant proportion of eyes after Ocriplasmin therapy. The EZ-RPE volume and the EZ-RPE central foveal area typically recover to baseline by 3 months. This effect appears to be panretinal and associated with subjective symptoms.

  • assessment of retinal alterations after intravitreal Ocriplasmin with spectral domain optical coherence tomography
    Ophthalmology, 2014
    Co-Authors: Yuji Itoh, Sunil K Srivastava, Peter K Kaiser, Rishi P Singh, Justis P Ehlers
    Abstract:

    Ocriplasmin (Jetrea, Thrombogenics, Leuvin, Belgium) was recently FDA-approved for the treatment of symptomatic vitreomacular traction (VMT). The MIVI-TRUST phase 3 randomized control trials revealed that intravitreal Ocriplasmin had superior efficacy for VMT resolution compared to placebo vehicle injection.1 Qualitative identification of outer retinal changes following Ocriplasmin injection that were not previously recognized in the MIVI-TRUST trials have recently been described.2, 3, 4 In those reports, the outer segment ellipsoid zone (EZ), also referred to as inner segment/outer segment (IS/OS) junction, appeared to be most impacted. Another retinal alteration that has been described following Ocriplasmin injection is increased subretinal fluid (SRF).2 The purpose of this study was to quantitatively evaluate retinal structural changes with spectral domain OCT (SD-OCT) following Ocriplasmin therapy. This was an IRB-approved retrospective consecutive case series and adhered to the tenets of the Declaration of Helsinki. Inclusion criteria included eyes that received intravitreal Ocriplasmin and SD-OCT imaging at baseline and at least 1 week following injection. Exclusion criteria included poor quality SD-OCT and concurrent macular disease that could affect visual acuity (VA) and/or retinal architecture. All eyes received intravitreal Ocriplasmin (125 µg). The SD-OCT examinations were performed with a Cirrus HD-OCT (Cirrus V.6.1 software, Carl Zeiss Meditec, Dublin, CA) at baseline and at post-injection time points. Inner, middle and outer retinal thicknesses 1.2 mm nasal, temporal, superior, and inferior to the fovea were calculated as previously described.5 Additionally, the distance between the EZ to retinal pigmentary epithelium (EZ-RPE height) was quantified. All measurements were performed in a masked fashion. For SRF volumetric analysis, a custom OCT software analysis program was utilized to manually segment the SRF volume. To compare two groups, Mann-Whitney U tests were used with nonparametric distribution data. Multivariate analysis was used to investigate the relationships between retinal architectural alterations and VA. Spearman’s rank correlation was also performed, as appropriate. A p-value of < 0.05 was considered to be significant. Nineteen eyes of 19 patients were identified that met the inclusion/exclusion criteria for this study. Mean age was 69.6 years (59–85) with 5 men (26%) and 14 women (74%). Twelve (63%) eyes were phakic and 7 (37%) eyes were pseudophakic. The mean visual acuity was 20/40 at baseline, 20/43 at 1 week post-injection, 20/38 at 1 month, and 20/32 at 3 months. Three months after injection, VMT release following Ocriplasmin injection was observed in 9 of 19 (47%) eyes. On SD-OCT analysis, 10 of 19 (53 %) eyes exhibited transient EZ loss [Figures 1 and 2 (available at http://aaojournal.org)]. Inner and middle retinal thicknesses were unchanged following Ocriplasmin therapy. Mean outer retinal thickness significantly decreased at 1 week (p = 0.00029), but gradually recovered at 1 month (p = 0.09) and 3 months (p = 0.91) following injection. The mean EZ-RPE height at baseline was significantly reduced at 1 week, at 1 month and at 3 months (p = 0.0001, < 0.0001, 0.00099, respectively) following injection (Figure 1). Figure 1 (A) Features identified on OCT 1 week following intravitreal Ocriplasmin, including vitreomacular traction release, ellipsoid zone (EZ) loss and subretinal fluid (SRF) accumulation. (B) Bar graph comparing value of EZ-retinal pigment epithelium (RPE) ... Retinal thickness assessments based on VMT release and SRF accumulation were also performed. One week after injection, EZ-RPE height was reduced in eyes with VMT release (14.9 ± 9.1µm compared to baseline) and without VMT release (8.9 ± 13.2 µm). One week following injection, the EZ-RPE height was reduced in eyes with increased SRF (21.9 ± 4.5 µm) but not in eyes without increased SRF (−0.52 ± 2.0 µm) and this was significantly different (p = 0.00024), Figure 1 and Table 1 (available at http://aaojournal.org). The amount of decreased EZ-RPE height was strongly correlated to accumulation of SRF accumulation (p = 0.00021, correlation coefficient = 0.88), Figure 1. As with any retrospective analysis, there are limitations to this study. The follow-up period is relatively short and the sample size small. Due to the retrospective nature, standardized follow-up could not be achieved. This study was also not controlled and did not have a comparison group, such as surgery, placebo injection, or pneumatic vitreolysis. Functional analysis within this study did not include potential important diagnostic testing, including ERG and microperimetry. Recent case reports following Ocriplasmin suggests similar acute panretinal dysfunction in rare cases. Outer retinal changes on SD-OCT and significant reduction in ERG amplitudes were present.3, 4 One report suggests that these changes may reflect degradation of laminin resulting in panretinal dysfunction secondary to Ocriplasmin.4 In our study, 10 of 19 eyes showed decreased length between the EZ and RPE (EZ-RPE height) one week after Ocriplasmin injection. All of these cases also exhibited increased SRF. This EZ-RPE height loss gradually recovered with time. Three months following injection, outer retinal thickness recovered to baseline. The origin of the increased SRF remains unclear. Potential hypotheses include alterations from vitreoretinal traction, transient breakdown of the outer blood-retinal barrier, inherent RPE dysfunction, and accumulation of photoreceptor outer segments. All cases that showed reduction in EZ-RPE height also showed an increase in volume of the SRF compared to baseline. There was a strong correlation in the change in EZ-RPE height and increase in SRF. This may support that the SRF origin is related to the degradation of photoreceptor outer segments. Although the hyporeflective nature of the SRF seen in our cases does not correspond with the typical OCT reflectivity of outer segments, in the presence of potential enzymatic changes it is unclear what characteristics outer segments would have on OCT. In addition, the the loss of standard directional orientation of the outer segments would change the OCT appearance. It is important to recognize that although the EZ band appears to rapidly reappear on the OCT qualitatively within a few weeks, it takes significantly longer for the baseline EZ-RPE height to be restored to preinjection levels. This may reflect the slow reaccumulation of the outer segments. Based on our review of the literature, we believe this represents the first quantitative assessment of the retinal alterations associated with Ocriplasmin therapy. Our study suggests that the outer retinal changes and subretinal fluid accumulation appear to be common findings following intravitreal Ocriplasmin injection and potentially interrelated. Retinal alterations appear to nearly normalize by 3 months, but the long-term implications of these findings need further prospective research.

Koen Willekens - One of the best experts on this subject based on the ideXlab platform.

  • phase i trial on robot assisted retinal vein cannulation with Ocriplasmin infusion for central retinal vein occlusion
    Acta Ophthalmologica, 2021
    Co-Authors: Koen Willekens, Jean H. M. Feyen, Andy Gijbels, Jonas Smits, Laurent Schoevaerdts, Johan Blanckaert, Dominiek Reynaerts, Peter Stalmans
    Abstract:

    PURPOSE To evaluate the safety and feasibility of robot-assisted retinal vein cannulation with Ocriplasmin infusion for central retinal vein occlusion. METHODS Prospective phase I trial including four patients suffering from central retinal vein occlusion (CRVO). Diagnosis was confirmed by preoperative fluo-angiography and followed by a standard three-port pars plana vitrectomy. Afterwards, a custom-built microneedle was inserted into a branch retinal vein with robotic assistance and infusion of Ocriplasmin started. Primary outcomes were the occurrence of intra-operative complications and success of cannulation. Secondary outcomes were change in visual acuity, central macular thickness (CMT) and venous filling times (VFT) during fluo-angiography two weeks after the intervention. RESULTS Cannulation with infusion of Ocriplasmin was successful in all four eyes with a mean total infusion time of 355 ± 204 seconds (range 120-600 seconds). Best corrected visual acuity (BCVA) remained counting fingers (CF) in case 3 and 4, increased in case 1 from CF to 0.9LogMAR and decreased in case 2 from 0.4 to 1.3 LogMAR. CMT and VFT both showed a trend towards significant decrease comparing preoperative measurements with two weeks postintervention (1061 ± 541 μm versus 477 ± 376 μm, p = 0.068) and 24 ll 4 seconds versus 15 ± 1 seconds, p = 0.068, respectively). In one eye a needle tip broke and could be removed with an endoforceps. There were no other intervention-related complications. CONCLUSION Robot-assisted retinal vein cannulation is feasible and safe. Local intravenous infusion with Ocriplasmin led to an improved retinal circulation.

  • improved efficacy of Ocriplasmin for vitreomacular traction release and transient changes in optic disk morphology
    Retina-the Journal of Retinal and Vitreous Diseases, 2015
    Co-Authors: Koen Willekens, Evelien Vandewalle, Ingeborg Stalmans, Luis Abegao Pinto, Peter Stalmans
    Abstract:

    Purpose To determine the efficacy and safety of Ocriplasmin for vitreomacular traction (VMT) resolution and to study changes in optic disk and peripapillary region. Methods Retrospective, single-center, observational case series. In 38 eyes with VMT (10 with concomitant full-thickness macular hole), determined by optical coherence tomography, a single intravitreal injection of Ocriplasmin was administered. Baseline ocular characteristics included the presence/absence of epiretinal membrane, lens status, and vitreomacular adhesion size. Spectral domain optical coherence tomography and Heidelberg retinal tomography were performed at baseline and follow-up visits. Results A total of 71.1% of eyes treated with Ocriplasmin had VMT resolution, improving to 83.9% after applying MIVI-TRUST selection criteria. A total of 90% of eyes with full-thickness macular hole showed VMT resolution, with 40% of those achieving full-thickness macular hole closure. Subretinal fluid in the macular region was observed in 36.8% of eyes 1 day after injection, and all cleared spontaneously by Day 42. A significant difference was observed in cup/disk area ratio between patients who achieved VMT resolution and patients who did not. Conclusion Careful patient selection improves Ocriplasmin efficacy. Transient optic disk morphology changes such as decreased cup/disk area ratio may occur in patients without VMT resolution.

  • treatment of vitreomacular traction with Ocriplasmin in a non reimbursed setting
    Acta Ophthalmologica, 2014
    Co-Authors: Koen Willekens, L A Pinto, Evelien Vandewalle, Ingeborg Stalmans, Peter Stalmans
    Abstract:

    Purpose Vitreomacular adhesion can lead to vitreomacular traction (VMT) and macular hole (MH) formation. Intravitreal Ocriplasmin provides a non-surgical solution to release VMT with or without macular hole. A series of 37 patients treated with Ocriplasmin is presented. Since Ocriplasmin was used in a non-reimbursed setting, the injection was only recommended when a high success chance was anticipated (e.g. excluding patients with a concomitant epiretinal membrane). Methods An observational trial was conducted on 37 patients with VMT +/- MH treated with Ocriplasmin with a minimal follow up time of 28 days. Patients had OCT scans of the macular and papillary region prior to the treatment and regularly in the following month. Data on papillary changes were also recorded by Heidelberg Retinal Tomography. Results Overall, 38 eyes of 37 patients were treated (27 with VMT and 11 with VMT+MH). VMT resolved in 28 cases (74%) and macular holes closed in 4 cases (36%). The cup/disc ratio transiently became smaller, associated with a small increase in retinal nerve fiber layer thickness. Interestingly, formation of transient subretinal fluid was observed in the subfoveal and peripapillar region in some patients and a subfoveal drusenoid deposit disappeared in two patients after injection. Conclusion A high success rate of VMT release can be obtained after injection of Ocriplasmin when patients are carefully selected. Further research on observed transient changes in the appearance of subretinal fluid and the peripapillary nerve fiber layer thickness is needed.

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  • cost effectiveness analysis of Ocriplasmin versus watchful waiting for treatment of symptomatic vitreomacular adhesion in the us
    Journal of Comparative Effectiveness Research, 2020
    Co-Authors: Arshad M Khanani, Pravin U Dugel, Julia A Haller, Alan L Wagner, Benedicte Lescrauwaet, Ralph Schmidt, Craig Bennison
    Abstract:

    Aim: Evaluate the cost-effectiveness of Ocriplasmin in symptomatic vitreomacular adhesion (VMA) with or without full-thickness macular hole ≤400 μm versus standard of care. Methods: A state-transition model simulated a cohort through disease health states; assignment of utilities to health states reflected the distribution of visual acuity. Efficacy of Ocriplasmin was derived from logistic regression models using Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole trial data. Model inputs were extracted from Phase III trials and published literature. The analysis was conducted from a US Medicare perspective. Results: Lifetime incremental cost-effectiveness ratio was US$4887 per quality-adjusted life year gained in the total population, US$4255 and US$10,167 in VMA subgroups without and with full-thickness macular hole, respectively. Conclusion: Ocriplasmin was cost effective compared with standard of care in symptomatic VMA.

  • budget impact analysis of Ocriplasmin for the treatment of symptomatic vitreomacular adhesion in the usa
    Journal of Comparative Effectiveness Research, 2018
    Co-Authors: Pravin U Dugel, Julia A Haller, Peter K Kaiser, Renee Jg Arnold
    Abstract:

    BACKGROUND Vitreomacular traction (VMT) treatment options include watchful waiting, vitrectomy and intravitreal Ocriplasmin injection (Jetrea®). This analysis used results from the recently completed OASIS randomized clinical trial to evaluate the 2-year budget impact of Ocriplasmin injection availability for treatment of Stage I or II VMT without epiretinal membrane formation in a modeled US health plan. MATERIALS & METHODS VMT prevalence, treatment patterns and disease resolution rates were from literature, a US retinal-specialist survey and the OASIS trial. Medicare payment rates were applied and a national scenario analysis was conducted. RESULTS With Ocriplasmin available, vitrectomy use and complications-related costs decreased. Budget impact of Ocriplasmin to the health plan was US$143,599 over 2 years or US$0.0060 per-member per-month. CONCLUSION Ocriplasmin was projected to be minimally cost-additive at US$0.0060 per-member per-month over 2 years.

  • Ocriplasmin for Treatment of Vitreomacular Traction: An Update
    Ophthalmology and Therapy, 2016
    Co-Authors: Mohammed Ali Khan, Julia A Haller
    Abstract:

    Pharmacologic vitreolysis with Ocriplasmin, a 27 kilodalton serine protease, is an effective nonsurgical treatment option for vitreomacular traction (VMT). Data from phase III clinical studies, including the Microplasmin for Intravitreal Injection—Traction Release without Surgical Treatment (MIVI-TRUST) and Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole (OASIS) studies, have demonstrated the treatment efficacy of Ocriplasmin for VMT and full-thickness macular hole (FTMH). Subgroup analysis of these clinical trials as well as post-marketing clinical series have aided in patient selection by identifying features associated with successful pharmacologic release of VMT with Ocriplasmin, including adhesion diameter ≤1500 μm, absence of epiretinal membrane, phakic status, and age younger than 65. As a first-in-class therapeutic, Ocriplasmin and its side effects have been carefully monitored by the vitreoretinal community. The following categories of related or possibly related adverse events have been identified: acute reduction in visual acuity, ERG changes, dyschromatopsia, retinal tear or detachment, lens subluxation or phacodonesis, abnormal pupillary reflex, retinal vascular changes, and OCT ellipsoid zone alterations. Adverse events have almost all been transient with restoration of visual acuity; however, in select patients, alterations may persist.

  • improvement in patient reported visual function after Ocriplasmin for vitreomacular adhesion results of the microplasmin for intravitreous injection traction release without surgical treatment mivi trust trials
    JAMA Ophthalmology, 2015
    Co-Authors: Rohit Varma, Julia A Haller, Peter K Kaiser
    Abstract:

    Importance The impact of vitreomacular adhesion (VMA) resolution on patient-reported visual function in symptomatic VMA/vitreomacular traction (VMT) has not yet been documented, to our knowledge. Objective To determine the impact of intravitreal Ocriplasmin on patient-reported visual function using the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) during a 6-month follow-up in patients with symptomatic VMA. Design, Setting, and Participants Two multicenter, randomized, masked, phase 3 clinical trials (studies TG-MV-006 [between December 2008 and April 2010] and TG-MV-007 [between December 2008 and July 2010]) at clinic-based centers in the United States and Europe. A total of 652 patients with symptomatic VMA/VMT, including when associated with a macular hole 400 μm or smaller, were studied. Analysis was by intent-to-treat population and performed in May 2013. Interventions Patients with symptomatic VMA/VMT were randomly assigned (2:1 or 3:1 in study TG-MV-006 and study TG-MV-007, respectively) to receive a single intravitreal injection of Ocriplasmin, 125 μg, or placebo-injected vehicle (placebo). The NEI VFQ-25 was administered at baseline and 6 months following Ocriplasmin injection. Main Outcomes and Measures Mean changes between baseline and 6-month follow-up NEI VFQ-25 composite and subscale scores and the proportion of patients with a clinically meaningful change (≥5 points) in scores. Results Across the 2 studies, 464 patients received Ocriplasmin and 188 received placebo. At 6 months, the Ocriplasmin group reported greater mean improvements from baseline in the NEI VFQ-25 composite score than the placebo group (mean change, 3.4 vs 0.7, respectively; P  = .005). Improvements were also noted in subscale scores, with the following respective mean changes for the Ocriplasmin vs placebo groups: vision-related dependency, 1.7 vs −2.1 ( P  = .009); driving difficulty, 2.7 vs −1.5 ( P  = .03); distance vision activities, 4.1 vs 0.8 ( P  = .03); and general vision, 6.1 vs 2.1 ( P  = .003). A higher proportion of the Ocriplasmin group had a clinically meaningful (≥5-point) improvement in NEI VFQ-25 composite score from baseline than the placebo group (36.0% vs 27.2%, respectively; P  = .03). Fewer Ocriplasmin-treated patients had a clinically meaningful worsening in their visual function than the placebo group (15.0% vs 24.3%, respectively; P  = .005). Changes in NEI VFQ-25 composite score and various subscale scores were observed in Ocriplasmin-treated patients who achieved VMA resolution at day 28. Conclusions and Relevance Ocriplasmin produces clinically meaningful improvement in patient-reported visual function in symptomatic VMA/VMT. Trial Registration clinicaltrials.gov Identifiers:NCT00781859andNCT00798317

  • improvement in patient reported visual function after Ocriplasmin for vitreomacular adhesion results of the microplasmin for intravitreous injection traction release without surgical treatment mivi trust trials
    JAMA Ophthalmology, 2015
    Co-Authors: Rohit Varma, Julia A Haller, Peter K Kaiser
    Abstract:

    Importance The impact of vitreomacular adhesion (VMA) resolution on patient-reported visual function in symptomatic VMA/vitreomacular traction (VMT) has not yet been documented, to our knowledge. Objective To determine the impact of intravitreal Ocriplasmin on patient-reported visual function using the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) during a 6-month follow-up in patients with symptomatic VMA. Design, Setting, and Participants Two multicenter, randomized, masked, phase 3 clinical trials (studies TG-MV-006 [between December 2008 and April 2010] and TG-MV-007 [between December 2008 and July 2010]) at clinic-based centers in the United States and Europe. A total of 652 patients with symptomatic VMA/VMT, including when associated with a macular hole 400 μm or smaller, were studied. Analysis was by intent-to-treat population and performed in May 2013. Interventions Patients with symptomatic VMA/VMT were randomly assigned (2:1 or 3:1 in study TG-MV-006 and study TG-MV-007, respectively) to receive a single intravitreal injection of Ocriplasmin, 125 μg, or placebo-injected vehicle (placebo). The NEI VFQ-25 was administered at baseline and 6 months following Ocriplasmin injection. Main Outcomes and Measures Mean changes between baseline and 6-month follow-up NEI VFQ-25 composite and subscale scores and the proportion of patients with a clinically meaningful change (≥5 points) in scores. Results Across the 2 studies, 464 patients received Ocriplasmin and 188 received placebo. At 6 months, the Ocriplasmin group reported greater mean improvements from baseline in the NEI VFQ-25 composite score than the placebo group (mean change, 3.4 vs 0.7, respectively; P  = .005). Improvements were also noted in subscale scores, with the following respective mean changes for the Ocriplasmin vs placebo groups: vision-related dependency, 1.7 vs −2.1 ( P  = .009); driving difficulty, 2.7 vs −1.5 ( P  = .03); distance vision activities, 4.1 vs 0.8 ( P  = .03); and general vision, 6.1 vs 2.1 ( P  = .003). A higher proportion of the Ocriplasmin group had a clinically meaningful (≥5-point) improvement in NEI VFQ-25 composite score from baseline than the placebo group (36.0% vs 27.2%, respectively; P  = .03). Fewer Ocriplasmin-treated patients had a clinically meaningful worsening in their visual function than the placebo group (15.0% vs 24.3%, respectively; P  = .005). Changes in NEI VFQ-25 composite score and various subscale scores were observed in Ocriplasmin-treated patients who achieved VMA resolution at day 28. Conclusions and Relevance Ocriplasmin produces clinically meaningful improvement in patient-reported visual function in symptomatic VMA/VMT. Trial Registration clinicaltrials.gov Identifiers:NCT00781859andNCT00798317