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Jeffrey S. Heier – One of the best experts on this subject based on the ideXlab platform.

  • improvement in vision related function with intravitreal Aflibercept data from phase 3 studies in wet age related macular degeneration
    Ophthalmology, 2015
    Co-Authors: Mitsuko Yuzawa, Oliver Zeitz, Peter K. Kaiser, Jeffrey S. Heier, Kyoko Fujita, K U Wittrupjensen, Christiane Norenberg, K Adachi, E C Y Wang, Victor Chong
    Abstract:

    Purpose To evaluate the effect of intravitreal Aflibercept injection on visual function in wet age-related macular degeneration (AMD). Design Prospective, multicenter, double-masked, active-controlled, parallel-group, randomized phase 3 clinical studies (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD [VIEW] 1 and 2 [clinicaltrials.gov identifiers, NCT00509795 and NCT00637377, respectively]). Participants Patients (n = 2419) with active, treatment-naive, exudative AMD. This analysis included patients who received intravitreal Aflibercept 2.0 mg every 8 weeks (2q8; n = 607) or ranibizumab 0.5 mg every 4 weeks (0.5q4; n = 595). Intervention Patients were randomized 1:1:1:1 to receive intravitreal Aflibercept 2q8 (after 3 initial monthly doses), intravitreal Aflibercept 2q4, intravitreal Aflibercept 0.5q4, or ranibizumab 0.5q4 in the study eye. Patients in the intravitreal Aflibercept 2q8 group received a sham injection alternating with active treatment. Main Outcome Measures The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) was administered at baseline and at weeks 12, 24, 36, and 52. The NEI VFQ-25 subscale scores were compared between intravitreal Aflibercept 2q8 and ranibizumab 0.5q4 treatment arms, the approved dosing for each agent worldwide. Change in composite NEI VFQ-25 score was evaluated based on categorical change in visual acuity (worsened, unchanged, improved). Results Baseline NEI VFQ-25 scores were similar for both treatments in both studies. Mean change from baseline to 52 weeks was similar for ranibizumab 0.5q4 and intravitreal Aflibercept 2q8 across all 12 subscales, with the greatest improvements noted for mental health and general vision (9.0–11.6 points, both treatments, both studies). Improvement of 4 points or more (both treatments, both studies) also was observed for subscales near vision, distance vision, role difficulties, and dependency. Mean change from baseline to 52 weeks in NEI VFQ-25 composite score (pooled data) stratified by clinical response showed meaningful improvement only in patients who gained 5 Early Treatment Diabetic Retinopathy letters or more (7.3 and 7.8 points for intravitreal Aflibercept 2q8 and ranibizumab 0.5q4, respectively). Conclusions Visual function outcomes were similar across all NEI VFQ-25 subscales over 52 weeks for intravitreal Aflibercept 2q8 and ranibizumab 0.5q4, with clinically meaningful improvement recorded in 6 of 12 subscales.

  • Noninfectious inflammation after intravitreal injection of Aflibercept: clinical characteristics and visual outcomes.
    American journal of ophthalmology, 2014
    Co-Authors: Roger A. Goldberg, Chirag Shah, Torsten W Wiegand, Jeffrey S. Heier
    Abstract:

    Purpose To report the presenting features and clinical outcomes of a series of patients with noninfectious inflammation after intravitreal Aflibercept injection. Design Noncomparative consecutive case series. Methods Medical records of patients who presented with noninfectious inflammation after intravitreal Aflibercept injection between November 18, 2011 and June 30, 2013 were retrospectively reviewed. Results A total of 20 cases of postinjection inflammation were identified in 5356 Aflibercept injections. The patients presented 1–13 days after Aflibercept injection (median 3 days); all noted decreased vision, while 3 of 20 (15%) had pain and 2 of 20 (10%) had conjunctival injection. One patient had a hypopyon (0.5 mm), and the average anterior chamber cell was 1.8+ (range 0 to 4+). All eyes had some degree of vitritis (average 1.8+; range 0.5+ to 4+). Patients on average had received 6 prior Aflibercept injections (range 0–16). Only 1 patient—the first to present with inflammation in this series—received an intravitreal tap (culture negative) and injection of antibiotics. All patients were managed with frequent topical steroids and were followed closely for signs of improvement. All but 1 patient regained their preinjection visual acuity (average: 33 days; range: 7–73 days). Four patients were subsequently rechallenged with Aflibercept, and 1 developed inflammation again after 5 additional Aflibercept injections. The overall incidence of inflammation after intravitreal Aflibercept injection was 20 of 5356 injections (0.37%) or 19 of 844 patients (2.25%). However, a disproportionate number of cases clustered around 1 provider (17/20, 85%; P P Conclusions Noninfectious inflammation after intravitreal Aflibercept injection typically presents without pain, conjunctival injection, or hypopyon, and responds to topical stersteroid therapy. The visual outcomes are generally favorable, though the return to baseline acuity can take many weeks.

  • Initial utilization of Aflibercept in exudative age-related macular degeneration.
    European journal of ophthalmology, 2014
    Co-Authors: Hyung Cho, Chirag Shah, Marissa L. Weber, Jeffrey S. Heier
    Abstract:

    PURPOSE Intravitreal Aflibercept, a fusion protein with high affinity for vascular endothelial growth factor, offers an alternative treatment for exudative age-related macular degeneration. Preclinical studies and early and late phase clinical trials suggest that Aflibercept‘s high binding affinity may impart greater durability of activity and increased efficacy compared to ranibizumab or bevacizumab. METHODS A total of 266 eyes of 249 patients with exudative age-related macular degeneration who received Aflibercept after treatment with bevacizumab and/or ranibizumab were included in a retrospective review. Mean central subfoveal thickness on spectral-domain optical coherence tomography and mean logarithm of the minimal angle of resolution (logMAR) visual acuity were calculated at 1, 3, 6, and 12 months after the first Aflibercept injection. Subgroup analyses were performed in eyes receiving at least 5 bevacizumab and/or ranibizumab injections in the 6 months prior to Aflibercept and in eyes receiving at least 10 injections in the 12 months prior to Aflibercept. RESULTS Eyes received an average of 14.7 (range 1-43) ranibizumab and/or bevacizumab treatments prior to initiation of Aflibercept therapy. The mean central subfoveal thickness decreased from 300 to 275 µm at 1 month (p

Jeanfrancois Korobelnik – One of the best experts on this subject based on the ideXlab platform.

  • intravitreal Aflibercept injection in patients with myopic choroidal neovascularization the myrror study
    Ophthalmology, 2015
    Co-Authors: Yasushi Ikuno, Kyoko Ohnomatsui, Tien Yin Wong, Jeanfrancois Korobelnik, Robert Vitti, Tummy Li, Brigitte Stemper, Friedrich Asmus
    Abstract:

    Purpose To evaluate intravitreal Aflibercept 2 mg in patients with myopic choroidal neovascularization (CNV). Design An international, phase III, multicenter, randomized, double-masked, sham-controlled study. Participants Patients aged ≥18 years with high myopia (≤−6.0 diopters or axial length of ≥26.5 mm), active myopic CNV, and best-corrected visual acuity (BCVA) of 73–35 Early Treatment Diabetic Retinopathy Study letters in the study eye were included. Methods Patients were randomized 3:1 to intravitreal Aflibercept or sham. In the intravitreal Aflibercept arm, patients received 1 injection at baseline. Additional injections were performed in case of CNV persistence or recurrence at monthly visits through week 44. In the sham arm, patients received sham injections through week 20. At week 24, after assessment of the primary efficacy end point, sham patients received a mandatory intravitreal Aflibercept injection followed by intravitreal Aflibercept (if disease persisted/recurred) or sham injection every 4 weeks. Main Outcome Measures Mean change in BCVA from baseline to week 24. Results A total of 122 patients were randomized to intravitreal Aflibercept (n = 91) or sham (n = 31). Baseline demographics were similar across groups. At week 24, patients in the intravitreal Aflibercept and sham groups gained 12.1 and lost 2 letters, respectively ( P Conclusions Intravitreal Aflibercept 2 mg was effective for treatment of myopic CNV with clinically important visual and anatomic benefits achieved with a limited number of injections given in the first 8 weeks of treatment. No new safety concerns occurred with treatment. Intravitreal Aflibercept should be considered as a treatment option for myopic CNV.

  • Original articleIntravitreal Aflibercept Injection in Patients with Myopic Choroidal Neovascularization: The MYRROR Study
    Ophthalmology, 2015
    Co-Authors: Yasushi Ikuno, Friedrich Asmus, Tien Yin Wong, Jeanfrancois Korobelnik, Robert Vitti, Brigitte Stemper, Kyoko Ohno-matsui, Oliver Zeitz, Tatsuro Ishibashi
    Abstract:

    Purpose To evaluate intravitreal Aflibercept 2 mg in patients with myopic choroidal neovascularization (CNV). Design An international, phase III, multicenter, randomized, double-masked, sham-controlled study. Participants Patients aged ≥18 years with high myopia (≤−6.0 diopters or axial length of ≥26.5 mm), active myopic CNV, and best-corrected visual acuity (BCVA) of 73–35 Early Treatment Diabetic Retinopathy Study letters in the study eye were included. Methods Patients were randomized 3:1 to intravitreal Aflibercept or sham. In the intravitreal Aflibercept arm, patients received 1 injection at baseline. Additional injections were performed in case of CNV persistence or recurrence at monthly visits through week 44. In the sham arm, patients received sham injections through week 20. At week 24, after assessment of the primary efficacy end point, sham patients received a mandatory intravitreal Aflibercept injection followed by intravitreal Aflibercept (if disease persisted/recurred) or sham injection every 4 weeks. Main Outcome Measures Mean change in BCVA from baseline to week 24. Results A total of 122 patients were randomized to intravitreal Aflibercept (n = 91) or sham (n = 31). Baseline demographics were similar across groups. At week 24, patients in the intravitreal Aflibercept and sham groups gained 12.1 and lost 2 letters, respectively ( P Conclusions Intravitreal Aflibercept 2 mg was effective for treatment of myopic CNV with clinically important visual and anatomic benefits achieved with a limited number of injections given in the first 8 weeks of treatment. No new safety concerns occurred with treatment. Intravitreal Aflibercept should be considered as a treatment option for myopic CNV.

  • intravitreal Aflibercept for macular edema secondary to central retinal vein occlusion 18 month results of the phase 3 galileo study
    American Journal of Ophthalmology, 2014
    Co-Authors: Yuichiro Ogura, Ursula Schmidterfurth, Christian Simader, Jeanfrancois Korobelnik, Robert Vitti, J Roider, Frank G Holz, Alyson J Berliner, Florian Hiemeyer
    Abstract:

    Purpose To evaluate intravitreal Aflibercept for treatment of macular edema secondary to central retinal vein occlusion (CRVO). Design Randomized, double-masked, phase 3 study. Methods A total of 177 patients with macular edema secondary to CRVO were randomized to receive 2 mg intravitreal Aflibercept (n = 106) or sham (n = 71) every 4 weeks for 20 weeks. From weeks 24 to 48, patients were monitored every 4 weeks; the former group received intravitreal Aflibercept as needed (PRN), and the sham group received sham. From weeks 52 to 76, patients were monitored every 8 weeks, and both groups received intravitreal Aflibercept PRN. The primary endpoint (proportion of patients who gained ≥15 letters) was at week 24. This study reports exploratory outcomes at week 76. Results The proportion of patients who gained ≥15 letters in the intravitreal Aflibercept and sham groups was 60.2% vs 22.1% at week 24 (patients discontinued before week 24 were considered nonresponders; P P P .001). Mean μm change from baseline central retinal thickness was −448.6 vs −169.3 at week 24 ( P P P  = .1122). Over 76 weeks, the most common ocular serious adverse event in the intravitreal Aflibercept group was macular edema (3.8%). Conclusions The visual and anatomic improvements seen after fixed, monthly dosing at week 24 were largely maintained when treatment intervals were extended. Patients with macular edema following CRVO benefited from early treatment with intravitreal Aflibercept.

David S. Boyer – One of the best experts on this subject based on the ideXlab platform.

  • long term outcomes with as needed Aflibercept in diabetic macular oedema 2 year outcomes of the endurance extension study
    British Journal of Ophthalmology, 2018
    Co-Authors: Charles C Wykoff, Rahul N. Khurana, David M Brown, Lloyd W Clark, David S. Boyer
    Abstract:

    Background/aims To evaluate the efficacy and safety of individualised 2.0 mg intravitreal Aflibercept retreatment for diabetic macular oedema (DME) through the fifth year of management. Methods This is a phase IV, 2-year, open-label extension study. Sixty patients completing the 3-year VISTA DME (Study of Intravitreal Aflibercept Injection in Patients With Diabetic Macular Edema) phase III trial enrolled in the ENDURANCE (Long-Term Efficacy and Safety of Intravitreal Aflibercept for the Treatment of DME in Subjects Who Completed the VISTA DME Trial) extension study. All patients received Aflibercept in the presence of clinically relevant DME. Intervals between visits were prescribed according to disease activity. The main outcome measure was mean Aflibercept injections given through 2 years. Results A mean of 7.7 Aflibercept injections were administered through 2 years. Fifteen (25%) patients required no retreatment and 48% (n=29) of patients received five or fewer injections through 2 years. Among patients who received at least one Aflibercept retreatment during ENDURANCE, the mean number of injections through 2 years was 9.5. The mean visual acuity and central retinal thickness gains achieved during VISTA DME were maintained and stable during ENDURANCE. The most notable safety signal was progression of diabetic retinopathy. Six (10%) patients converted from non-proliferative to proliferative diabetic retinopathy (PDR), and a total of eight patients experienced PDR events occurring at a mean of 387 days following the previous Aflibercept treatment. Conclusion The need for Aflibercept retreatment was substantially reduced in the fourth and fifth years of Aflibercept dosing for DME following initiation of therapy in the VISTA DME trial. While vision gains achieved during the 3-year VISTA DME trial were maintained through ENDURANCE with a reduced treatment burden, clinically relevant worsening of diabetic retinopathy was observed with progression to PDR in 10% of the eyes. Trial registration number NCT02299336

  • safety profiles of anti vegf drugs bevacizumab ranibizumab Aflibercept and ziv Aflibercept on human retinal pigment epithelium cells in culture
    British Journal of Ophthalmology, 2014
    Co-Authors: Deepika Malik, Mohamed Tarek, Claudio Ramirez, David S. Boyer, Javier Caceres Del Carpio, Cristina M Kenney, Baruch D. Kuppermann
    Abstract:

    PURPOSE: To compare the safety profiles of antivascular endothelial growth factor (VEGF) drugs ranibizumab, bevacizumab, Aflibercept and ziv-Aflibercept on retinal pigment epithelium cells in culture. METHODS: Human retinal pigment epithelium cells (ARPE-19) were exposed for 24 h to four anti-VEGF drugs at 1/2×, 1×, 2× and 10× clinical concentrations. Cell viability and mitochondrial membrane potential assay were performed to evaluate early apoptotic changes and rate of overall cell death. RESULTS: Cell viability decreased at 10× concentrations in bevacizumab (82.38%, p=0.0001), Aflibercept (82.68%, p=0.0002) and ziv-Aflibercept (77.25%, p<0.0001), but not at lower concentrations. However, no changes were seen in cell viability in ranibizumab-treated cells at all concentrations including 10×. Mitochondrial membrane potential was slightly decreased in 10× ranibizumab-treated cells (89.61%, p=0.0006) and 2× and 10× Aflibercept-treated cells (88.76%, 81.46%; p<0.01, respectively). A larger reduction in mitochondrial membrane potential was seen at 1×, 2× and 10× concentrations of bevacizumab (86.53%, 74.38%, 66.67%; p<0.01) and ziv-Aflibercept (73.50%, 64.83% and 49.65% p<0.01) suggestive of early apoptosis at lower doses, including the clinical doses. CONCLUSIONS: At clinical doses, neither ranibizumab nor Aflibercept produced evidence of mitochondrial toxicity or cell death. However, bevacizumab and ziv-Aflibercept showed mild mitochondrial toxicity at clinically relevant doses.

  • Safety profiles of anti-VEGF drugs: bevacizumab, ranibizumab, Aflibercept and ziv-Aflibercept on human retinal pigment epithelium cells in culture
    British Journal of Ophthalmology, 2014
    Co-Authors: Deepika Malik, Mohamed Tarek, Javier Caceres Del Carpio, Claudio Ramirez, David S. Boyer, M. Cristina Kenney, Baruch D. Kuppermann
    Abstract:

    Purpose To compare the safety profiles of antivascular endothelial growth factor (VEGF) drugs ranibizumab, bevacizumab, Aflibercept and ziv-Aflibercept on retinal pigment epithelium cells in culture. Methods Human retinal pigment epithelium cells (ARPE-19) were exposed for 24 h to four anti-VEGF drugs at 1/2×, 1×, 2× and 10× clinical concentrations. Cell viability and mitochondrial membrane potential assay were performed to evaluate early apoptotic changes and rate of overall cell death. Results Cell viability decreased at 10× concentrations in bevacizumab (82.38%, p=0.0001), Aflibercept (82.68%, p=0.0002) and ziv-Aflibercept (77.25%, p Conclusions At clinical doses, neither ranibizumab nor Aflibercept produced evidence of mitochondrial toxicity or cell death. However, bevacizumab and ziv-Aflibercept showed mild mitochondrial toxicity at clinically relevant doses.

Robert Vitti – One of the best experts on this subject based on the ideXlab platform.

  • intravitreal Aflibercept injection in patients with myopic choroidal neovascularization the myrror study
    Ophthalmology, 2015
    Co-Authors: Yasushi Ikuno, Kyoko Ohnomatsui, Tien Yin Wong, Jeanfrancois Korobelnik, Robert Vitti, Tummy Li, Brigitte Stemper, Friedrich Asmus
    Abstract:

    Purpose To evaluate intravitreal Aflibercept 2 mg in patients with myopic choroidal neovascularization (CNV). Design An international, phase III, multicenter, randomized, double-masked, sham-controlled study. Participants Patients aged ≥18 years with high myopia (≤−6.0 diopters or axial length of ≥26.5 mm), active myopic CNV, and best-corrected visual acuity (BCVA) of 73–35 Early Treatment Diabetic Retinopathy Study letters in the study eye were included. Methods Patients were randomized 3:1 to intravitreal Aflibercept or sham. In the intravitreal Aflibercept arm, patients received 1 injection at baseline. Additional injections were performed in case of CNV persistence or recurrence at monthly visits through week 44. In the sham arm, patients received sham injections through week 20. At week 24, after assessment of the primary efficacy end point, sham patients received a mandatory intravitreal Aflibercept injection followed by intravitreal Aflibercept (if disease persisted/recurred) or sham injection every 4 weeks. Main Outcome Measures Mean change in BCVA from baseline to week 24. Results A total of 122 patients were randomized to intravitreal Aflibercept (n = 91) or sham (n = 31). Baseline demographics were similar across groups. At week 24, patients in the intravitreal Aflibercept and sham groups gained 12.1 and lost 2 letters, respectively ( P Conclusions Intravitreal Aflibercept 2 mg was effective for treatment of myopic CNV with clinically important visual and anatomic benefits achieved with a limited number of injections given in the first 8 weeks of treatment. No new safety concerns occurred with treatment. Intravitreal Aflibercept should be considered as a treatment option for myopic CNV.

  • Original articleIntravitreal Aflibercept Injection in Patients with Myopic Choroidal Neovascularization: The MYRROR Study
    Ophthalmology, 2015
    Co-Authors: Yasushi Ikuno, Friedrich Asmus, Tien Yin Wong, Jeanfrancois Korobelnik, Robert Vitti, Brigitte Stemper, Kyoko Ohno-matsui, Oliver Zeitz, Tatsuro Ishibashi
    Abstract:

    Purpose To evaluate intravitreal Aflibercept 2 mg in patients with myopic choroidal neovascularization (CNV). Design An international, phase III, multicenter, randomized, double-masked, sham-controlled study. Participants Patients aged ≥18 years with high myopia (≤−6.0 diopters or axial length of ≥26.5 mm), active myopic CNV, and best-corrected visual acuity (BCVA) of 73–35 Early Treatment Diabetic Retinopathy Study letters in the study eye were included. Methods Patients were randomized 3:1 to intravitreal Aflibercept or sham. In the intravitreal Aflibercept arm, patients received 1 injection at baseline. Additional injections were performed in case of CNV persistence or recurrence at monthly visits through week 44. In the sham arm, patients received sham injections through week 20. At week 24, after assessment of the primary efficacy end point, sham patients received a mandatory intravitreal Aflibercept injection followed by intravitreal Aflibercept (if disease persisted/recurred) or sham injection every 4 weeks. Main Outcome Measures Mean change in BCVA from baseline to week 24. Results A total of 122 patients were randomized to intravitreal Aflibercept (n = 91) or sham (n = 31). Baseline demographics were similar across groups. At week 24, patients in the intravitreal Aflibercept and sham groups gained 12.1 and lost 2 letters, respectively ( P Conclusions Intravitreal Aflibercept 2 mg was effective for treatment of myopic CNV with clinically important visual and anatomic benefits achieved with a limited number of injections given in the first 8 weeks of treatment. No new safety concerns occurred with treatment. Intravitreal Aflibercept should be considered as a treatment option for myopic CNV.

  • intravitreal Aflibercept for macular edema secondary to central retinal vein occlusion 18 month results of the phase 3 galileo study
    American Journal of Ophthalmology, 2014
    Co-Authors: Yuichiro Ogura, Ursula Schmidterfurth, Christian Simader, Jeanfrancois Korobelnik, Robert Vitti, J Roider, Frank G Holz, Alyson J Berliner, Florian Hiemeyer
    Abstract:

    Purpose To evaluate intravitreal Aflibercept for treatment of macular edema secondary to central retinal vein occlusion (CRVO). Design Randomized, double-masked, phase 3 study. Methods A total of 177 patients with macular edema secondary to CRVO were randomized to receive 2 mg intravitreal Aflibercept (n = 106) or sham (n = 71) every 4 weeks for 20 weeks. From weeks 24 to 48, patients were monitored every 4 weeks; the former group received intravitreal Aflibercept as needed (PRN), and the sham group received sham. From weeks 52 to 76, patients were monitored every 8 weeks, and both groups received intravitreal Aflibercept PRN. The primary endpoint (proportion of patients who gained ≥15 letters) was at week 24. This study reports exploratory outcomes at week 76. Results The proportion of patients who gained ≥15 letters in the intravitreal Aflibercept and sham groups was 60.2% vs 22.1% at week 24 (patients discontinued before week 24 were considered nonresponders; P P P .001). Mean μm change from baseline central retinal thickness was −448.6 vs −169.3 at week 24 ( P P P  = .1122). Over 76 weeks, the most common ocular serious adverse event in the intravitreal Aflibercept group was macular edema (3.8%). Conclusions The visual and anatomic improvements seen after fixed, monthly dosing at week 24 were largely maintained when treatment intervals were extended. Patients with macular edema following CRVO benefited from early treatment with intravitreal Aflibercept.

Ursula Schmidterfurth – One of the best experts on this subject based on the ideXlab platform.

  • morphology and visual acuity in Aflibercept and ranibizumab therapy for neovascular age related macular degeneration in the view trials
    Ophthalmology, 2016
    Co-Authors: Sebastian M Waldstein, Christian Simader, Giovanni Staurenghi, Victor N Chong, Paul Mitchell, Glenn J Jaffe, Todd A Katz, Ursula Schmidterfurth
    Abstract:

    Purpose To compare the efficacy of intravitreal Aflibercept and ranibizumab on the exudative activity of neovascular age-related macular degeneration (nAMD) using optical coherence tomography (OCT) and to correlate morphologic findings with visual acuity (VA) outcomes. Design Post hoc analysis of the prospective VIEW trials. Participants Data of 1815 patients randomized to 0.5 mg ranibizumab every 4 weeks (Q4wks), 2 mg Aflibercept Q4wks, or 2 mg Aflibercept every 8 weeks (Q8wks). Methods Standardized OCT evaluation was performed by masked reading centers for the presence of intraretinal cystoid fluid (IRC), subretinal fluid (SRF), and pigment epithelial detachment (PED). Rates of feature resolution were compared between drugs and regimen. Associations between morphologic features and VA were analyzed using multivariate modeling. Main Outcome Measures Resolution rates of IRC, SRF, and PED, and associations between morphology and VA. Results At baseline, the proportions of eyes with IRC, SRF, and PED were balanced between the Aflibercept and ranibizumab groups. At week 12, IRC resolved in 50% of eyes with both agents. Subretinal fluid resolved in 70% of pooled Aflibercept-treated eyes and in 59% of ranibizumab-treated eyes, and PED resolved in 29% and 24% of pooled Aflibercept-treated eyes and ranibizumab-treated eyes, respectively. At week 52, IRC resolved in 57% (Aflibercept Q4wks), 50% (Aflibercept Q8wks), and 52% (ranibizumab) of patients; SRF resolved in 75% (both Aflibercept Q4wks/Q8wks) and 66% (ranibizumab) of patients; and PED resolved in 40% (Aflibercept Q4wks), 34% (Aflibercept Q8wks), and 28% (ranibizumab) of patients. During fixed dosing (weeks 12–52) all exudative features showed synchronized fluctuations after treatment-free visits in the Q8wks Aflibercept regimen. During pro re nata dosing (weeks 52–96), greater proportions of patients showed recurrent fluid in all treatment arms. Presence of IRC was generally associated with lower VA at baseline, which translated into poorer final VA outcomes. Conclusions Fluid resolution in all compartments was consistently greater for Aflibercept Q4wks than for Aflibercept Q8wks and ranibizumab. At week 52, Q8wks Aflibercept–treated eyes were, on average, as dry as or drier than with ranibizumab despite the extended treatment interval. Independent of agent or regimen, preexisting morphologic features of the retina at baseline markedly influenced VA outcomes.

  • intravitreal Aflibercept for macular edema secondary to central retinal vein occlusion 18 month results of the phase 3 galileo study
    American Journal of Ophthalmology, 2014
    Co-Authors: Yuichiro Ogura, Ursula Schmidterfurth, Christian Simader, Jeanfrancois Korobelnik, Robert Vitti, J Roider, Frank G Holz, Alyson J Berliner, Florian Hiemeyer
    Abstract:

    Purpose To evaluate intravitreal Aflibercept for treatment of macular edema secondary to central retinal vein occlusion (CRVO). Design Randomized, double-masked, phase 3 study. Methods A total of 177 patients with macular edema secondary to CRVO were randomized to receive 2 mg intravitreal Aflibercept (n = 106) or sham (n = 71) every 4 weeks for 20 weeks. From weeks 24 to 48, patients were monitored every 4 weeks; the former group received intravitreal Aflibercept as needed (PRN), and the sham group received sham. From weeks 52 to 76, patients were monitored every 8 weeks, and both groups received intravitreal Aflibercept PRN. The primary endpoint (proportion of patients who gained ≥15 letters) was at week 24. This study reports exploratory outcomes at week 76. Results The proportion of patients who gained ≥15 letters in the intravitreal Aflibercept and sham groups was 60.2% vs 22.1% at week 24 (patients discontinued before week 24 were considered nonresponders; P P P .001). Mean μm change from baseline central retinal thickness was −448.6 vs −169.3 at week 24 ( P P P  = .1122). Over 76 weeks, the most common ocular serious adverse event in the intravitreal Aflibercept group was macular edema (3.8%). Conclusions The visual and anatomic improvements seen after fixed, monthly dosing at week 24 were largely maintained when treatment intervals were extended. Patients with macular edema following CRVO benefited from early treatment with intravitreal Aflibercept.

  • intravitreal Aflibercept injection for macular edema resulting from central retinal vein occlusion one year results of the phase 3 galileo study
    Ophthalmology, 2014
    Co-Authors: Ursula Schmidterfurth, Christian Simader, Jeanfrancois Korobelnik, Yuichiro Ogura, J Roider, Frank G Holz, Katrin Lorenz, Miki Honda, Robert Vitti
    Abstract:

    Purpose To evaluate the efficacy and safety of intravitreal Aflibercept injections for treatment of macular edema secondary to central retinal vein occlusion (CRVO). Design A randomized, multicenter, double-masked phase 3 study. Participants A total of 177 treatment-naive patients with macular edema secondary to CRVO were randomized in a 3:2 ratio. Methods Patients received either 2-mg intravitreal Aflibercept or sham injections every 4 weeks for 20 weeks. From week 24 to 48, the Aflibercept group received Aflibercept as needed (pro re nata [PRN]), and the sham group continued receiving sham injections. Main Outcome Measures The primary efficacy end point was the proportion of patients who gained 15 letters or more in best-corrected visual acuity (BCVA) at week 24. This study reports week 52 results including the proportion of patients who gained 15 letters or more in BCVA and the mean change from baseline BCVA and central retinal thickness. Efficacy end points at week 52 were all exploratory. Results At week 52, the mean percentage of patients gaining 15 letters or more was 60.2% in the Aflibercept group and 32.4% in the sham group ( P  = 0.0004). Aflibercept patients, compared with sham patients, had a significantly higher mean improvement in BCVA (+16.9 letters vs. +3.8 letters, respectively) and reduction in central retinal thickness (−423.5 μm vs. −219.3 μm, respectively) at week 52 ( P Conclusions Treatment with intravitreal Aflibercept provided significant functional and anatomic benefits after 52 weeks as compared with sham. The improvements achieved after 6 monthly doses at week 24 largely were maintained until week 52 with as-needed dosing. Intravitreal Aflibercept generally was well tolerated.