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Edward J Holland - One of the best experts on this subject based on the ideXlab platform.

  • tolerability and toxicity of topically applied Nepafenac 0 3 compared with generic ketorolac 0 5
    Journal of Cataract and Refractive Surgery, 2019
    Co-Authors: John A Hovanesian, Edward J Holland
    Abstract:

    Purpose To compare patient-reported tolerability, impact on quality of life, interference with activities of daily life, and ocular surface toxicity of branded Nepafenac 0.3% and generic ketorolac 0.5% after cataract surgery. Setting Harvard Eye Associates, Laguna Hills, California, and the Cincinnati Eye Institute, Ohio, USA. Design Prospective case series. Methods One eye of each patient was randomized to receive ketorolac 0.5% or Nepafenac 0.3% topical eyedrops for 3 days preoperatively and 28 days postoperatively. Additional medications were moxifloxacin 0.5% 4 times a day 3 days preoperatively and 7 days postoperatively and difluprednate 0.05% twice a day for 1 week postoperatively. Primary endpoints were patient-reported tolerability of each drug, the related impact on quality of life, and activities of daily life. Secondary endpoints were differences in conjunctival hyperemia, anterior chamber inflammation, tear breakup time (TBUT), and corneal staining. Results Baseline characteristics were similar between the Nepafenac group (n = 91) and the ketorolac group (n = 90). Burning and stinging lasted longer in the ketorolac group, while blurry/hazy/foggy vision and a film or coating on the eye lasted longer in the Nepafenac group (all P  Conclusion Branded Nepafenac 0.3%–treated patients had significantly better objective and subjective outcomes after cataract surgery than generic ketorolac 0.5%–treated patients.

  • double masked study of the effects of Nepafenac 0 1 and ketorolac 0 4 on corneal epithelial wound healing and pain after photorefractive keratectomy
    Advances in Therapy, 2007
    Co-Authors: Eric D Donnenfeld, Edward J Holland, Daniel S Durrie, Michael B Raizman
    Abstract:

    Two NSAIDs—Nepafenac 0.1% and ketorolac tromethamine 0.4%—were compared in terms of their effects on corneal reepithelialization and pain after photorefractive keratectomy (PRK) in a randomized, double-masked, contralateral eye, multicenter study. A total of 40 healthy adult patients who were undergoing sequential bilateral PRK received Nepafenac 0.1% and ketorolac 0.4% in contralateral eyes, 1 drop 3 times daily for 3 d after bandage contact lens insertion. Patients were assessed on postoperative days 1, 3, 4, 5, and 7. At each visit, patients provided a general rating of pain. Each patient also assessed the sensation of each eyedrop following instillation (after-drop pain, irritation, burning/stinging, and overall comfort). Starting on day 3, epithelial defect size was assessed. Mean epithelial defect size was similar between treatments at each postoperative visit (P > .05). The average time-to-healing was 4.18 d for Nepafenac 0.1 % and 4.00 d for ketorolac 0.4% (P=.3134). No statistical difference was observed between Nepafenac 0.1% and ketorolac 0.4% in mean postoperative pain scores (P > .05). On day 3, the Nepafenac 0.1% group had significantly lower mean sensation scores than did the ketorolac 0.4% group for after-drop pain (P=.0090), irritation (P=.0007), and burning/ stinging (P=.0003). Mean overall comfort score was also significantly better for Nepafenac 0.1% on day 3 (7.43 vs 6.41; P < .0001). Nepafenac 0.1% and ketorolac 0.4% provide postoperative pain relief after PRK surgery without associated adverse effects on corneal epithelial healing. Nepafenac 0.1 % treatment may offer greater comfort upon instillation in patients who have undergone PRK.

  • Nepafenac ophthalmic suspension 0 1 for the prevention and treatment of ocular inflammation associated with cataract surgery
    Journal of Cataract and Refractive Surgery, 2007
    Co-Authors: Stephen S Lane, Satish S Modi, Robert Lehmann, Edward J Holland
    Abstract:

    Purpose To determine whether Nepafenac ophthalmic suspension 0.1% decreases the incidence and severity of inflammation and pain after cataract surgery with posterior chamber intraocular lens implantation. Setting Twenty-one ophthalmology clinics in the United States. Methods A randomized double-blind vehicle-controlled trial was conducted in which adult patients were randomly assigned to receive Nepafenac 0.1% or vehicle beginning 1 day before surgery and continuing on the day of surgery (day 0) for 14 days. Patients were evaluated on days 1, 3, 7, and 14. The primary efficacy variable was the percentage of patients cured at day 14 (cure defined as aqueous cells score + aqueous flare score=0). Other efficacy variables included percentage of patients who were pain free at all visits and aqueous cells, flare, and cells plus flare scores. Results The mean age of the 476 patients (243 Nepafenac, 233 vehicle) was 70 years (range 27 to 93 years). At day 14, 152 patients (62.6%) in the Nepafenac group and 40 (17.2%) in the vehicle group were cured ( P P P Conclusion Nepafenac ophthalmic suspension 0.1% was safe and effective for preventing and treating ocular inflammation and pain associated with cataract surgery.

Robert Lehmann - One of the best experts on this subject based on the ideXlab platform.

  • Nepafenac 0 3 after cataract surgery in patients with diabetic retinopathy results of 2 randomized phase 3 studies
    Ophthalmology, 2017
    Co-Authors: Rishi P Singh, Alexis Tsorbatzoglou, Robert Lehmann, Giovanni Staurenghi, Ayala Pollack, Joseph N Martel, Kevin Jong, Guadalupe Cervantescoste Cervantes, Louis Alpern, Satish S Modi
    Abstract:

    Purpose To demonstrate the efficacy and safety of once-daily Nepafenac 0.3% ophthalmic suspension versus vehicle, based on clinical outcomes, after cataract surgery in patients with diabetes. Design Two prospective, randomized, multicenter, double-masked, vehicle-controlled phase 3 studies. Participants Total, 615 patients in study 1 and 605 patients in study 2. Methods Patients were randomized (1:1) to topical Nepafenac 0.3% or vehicle once-daily starting the day before surgery and continuing for 90 days thereafter. Main Outcome Measures Key efficacy variables were: patients (%) in whom macular edema (ME) developed (≥30% increase from preoperative baseline central subfield macular thickness) within 90 days after cataract surgery and the patients (%) with a best-corrected visual acuity (BCVA) improvement of ≥15 letters from preoperative baseline through day 14 maintained through day 90. Secondary end points included: patients (%) with a BCVA improvement of ≥15 letters from preoperative baseline through days 90 and 60 and safety over 3 months. Results A significantly lower percentage of patients demonstrated ME within 90 days after surgery with Nepafenac 0.3% versus vehicle (study 1: 2.3% vs. 17.3%; P P  = 0.001; pooled: 4.1% vs. 15.9%; P P P  = 0.671) in study 2, and 55.4% versus 46.7% ( P  = 0.003) in the pooled analysis. A greater percentage of patients treated with Nepafenac 0.3% versus vehicle in study 1 and similar percentage in study 2 had a BCVA improvement of ≥15 letters from preoperative baseline through day 90 (77.2% vs. 67.7% [ P  = 0.009] and 65.4% vs. 65.9% [ P  = 0.888]) and through day 60 (76.2% vs. 64.7% [ P  = 0.002] and 68.9% vs. 62.1% [ P  = 0.092]). No unanticipated adverse events were observed. Conclusions These studies demonstrated the clinical benefits of Nepafenac 0.3% over vehicle in reducing the risk of postoperative ME, with the integrated analysis showing improved BCVA after cataract surgery in patients with diabetic retinopathy, with no unanticipated safety events.

  • efficacy of Nepafenac ophthalmic suspension 0 1 in improving clinical outcomes following cataract surgery in patients with diabetes an analysis of two randomized studies
    Clinical Ophthalmology, 2017
    Co-Authors: Rishi P Singh, Dana Sager, Giovanni Staurenghi, Ayala Pollack, Adeniyi Adewale, Thomas M Walker, Robert Lehmann
    Abstract:

    OBJECTIVE: To assess the efficacy of Nepafenac 0.1% ophthalmic suspension in improving the clinical outcomes following cataract surgery (CS) in patients with nonproliferative diabetic retinopathy. METHODS: In two similar multicenter, randomized studies, patients received either Nepafenac 0.1% or vehicle, instilled three times daily starting a day prior to surgery and continuing for 90 days postoperatively. A post hoc analysis of these two studies was conducted to assess 1) the likelihood for development of postoperative macular edema (ME), based on the percentage of patients who developed ME (≥30% increase from preoperative baseline in central subfield macular thickness) within 90 days following CS and 2) best-corrected visual acuity (BCVA) endpoints, including the percentage of patients with a BCVA improvement of ≥15 letters from preoperative baseline to Day 14 and maintained through Day 90. Results for individual studies and their pooled estimates (only visual acuity endpoints) are reported. Primary inference was based on odds ratio (OR). RESULTS: This post hoc analysis included 411 patients (Nepafenac 0.1%: 205; vehicle: 206). The incidence of postoperative ME within 90 days of CS was notably lower in the Nepafenac-treated patients than in vehicle-treated patients (study 1: 3.2% vs 16.7%; OR =0.2, 95% confidence interval [CI] =0.1, 0.5, P=0.001; study 2: 5.0% vs 17.5%; OR =0.2, 95% CI =0.1, 0.8, P=0.018). A higher percentage of Nepafenac-treated patients than vehicle-treated patients gained ≥15 letters from preoperative baseline to Day 14, which was maintained through Day 90 (study 1: 38.4% vs 21.4%; OR =2.4, 95% CI =1.4, 4.2, P=0.003; study 2: 35.0% vs 25.0%; OR =1.6, 95% CI =0.8, 3.2, P=0.172; pooled: 37.1% vs 22.8%; OR =2.0, 95% CI =1.3, 3.1, P=0.001). The odds of >5-letter and >10-letter loss in BCVA from postoperative Day 7 were higher in vehicle-treated than in Nepafenac-treated patients. CONCLUSION: These results support the clinical benefit of prophylactic use of Nepafenac 0.1% for reducing the risk of postoperative ME and for improvement in BCVA outcomes following CS in patients with nonproliferative diabetic retinopathy.

  • in vivo pharmacokinetics and in vitro pharmacodynamics of Nepafenac amfenac ketorolac and bromfenac
    Journal of Cataract and Refractive Surgery, 2007
    Co-Authors: Thomas R Walters, Michael B Raizman, Paul H Ernest, Johnny L Gayton, Robert Lehmann
    Abstract:

    Purpose To evaluate the aqueous humor concentrations and cyclooxygenase (COX) inhibitory activities of Nepafenac, amfenac, ketorolac, and bromfenac after topical ocular administration of Nevanac (Nepafenac 0.1%), Acular LS (ketorolac 0.4%), or Xibrom (bromfenac 0.09%). Setting Five private ophthalmology practices throughout the United States. Methods Patients requiring cataract extraction were randomized to 1 of 3 treatment groups: Nevanac, Acular LS, or Xibrom. Patients were administered 1 drop of the test drug 30, 60, 120, 180, or 240 minutes before cataract surgery. At the time of paracentesis, an aqueous humor sample was collected and later analyzed for drug concentration. In addition, COX-1 (homeostatic) and COX-2 (inducible) inhibitory activities of Nepafenac, amfenac, ketorolac, and bromfenac were determined via the in vitro measurement of prostaglandin E2 (PGE2) inhibition. Results Seventy-five patients participated in the study. The prodrug Nepafenac had the shortest time to peak concentration and the greatest peak aqueous humor concentration (Cmax). The Cmax of Nepafenac was significantly higher than that of the other drugs (P Conclusion Nepafenac showed significantly greater ocular bioavailability and amfenac demonstrated greater potency at COX-2 inhibition than ketorolac or bromfenac.

  • Nepafenac ophthalmic suspension 0 1 for the prevention and treatment of ocular inflammation associated with cataract surgery
    Journal of Cataract and Refractive Surgery, 2007
    Co-Authors: Stephen S Lane, Satish S Modi, Robert Lehmann, Edward J Holland
    Abstract:

    Purpose To determine whether Nepafenac ophthalmic suspension 0.1% decreases the incidence and severity of inflammation and pain after cataract surgery with posterior chamber intraocular lens implantation. Setting Twenty-one ophthalmology clinics in the United States. Methods A randomized double-blind vehicle-controlled trial was conducted in which adult patients were randomly assigned to receive Nepafenac 0.1% or vehicle beginning 1 day before surgery and continuing on the day of surgery (day 0) for 14 days. Patients were evaluated on days 1, 3, 7, and 14. The primary efficacy variable was the percentage of patients cured at day 14 (cure defined as aqueous cells score + aqueous flare score=0). Other efficacy variables included percentage of patients who were pain free at all visits and aqueous cells, flare, and cells plus flare scores. Results The mean age of the 476 patients (243 Nepafenac, 233 vehicle) was 70 years (range 27 to 93 years). At day 14, 152 patients (62.6%) in the Nepafenac group and 40 (17.2%) in the vehicle group were cured ( P P P Conclusion Nepafenac ophthalmic suspension 0.1% was safe and effective for preventing and treating ocular inflammation and pain associated with cataract surgery.

Satish S Modi - One of the best experts on this subject based on the ideXlab platform.

  • Nepafenac 0 3 after cataract surgery in patients with diabetic retinopathy results of 2 randomized phase 3 studies
    Ophthalmology, 2017
    Co-Authors: Rishi P Singh, Alexis Tsorbatzoglou, Robert Lehmann, Giovanni Staurenghi, Ayala Pollack, Joseph N Martel, Kevin Jong, Guadalupe Cervantescoste Cervantes, Louis Alpern, Satish S Modi
    Abstract:

    Purpose To demonstrate the efficacy and safety of once-daily Nepafenac 0.3% ophthalmic suspension versus vehicle, based on clinical outcomes, after cataract surgery in patients with diabetes. Design Two prospective, randomized, multicenter, double-masked, vehicle-controlled phase 3 studies. Participants Total, 615 patients in study 1 and 605 patients in study 2. Methods Patients were randomized (1:1) to topical Nepafenac 0.3% or vehicle once-daily starting the day before surgery and continuing for 90 days thereafter. Main Outcome Measures Key efficacy variables were: patients (%) in whom macular edema (ME) developed (≥30% increase from preoperative baseline central subfield macular thickness) within 90 days after cataract surgery and the patients (%) with a best-corrected visual acuity (BCVA) improvement of ≥15 letters from preoperative baseline through day 14 maintained through day 90. Secondary end points included: patients (%) with a BCVA improvement of ≥15 letters from preoperative baseline through days 90 and 60 and safety over 3 months. Results A significantly lower percentage of patients demonstrated ME within 90 days after surgery with Nepafenac 0.3% versus vehicle (study 1: 2.3% vs. 17.3%; P P  = 0.001; pooled: 4.1% vs. 15.9%; P P P  = 0.671) in study 2, and 55.4% versus 46.7% ( P  = 0.003) in the pooled analysis. A greater percentage of patients treated with Nepafenac 0.3% versus vehicle in study 1 and similar percentage in study 2 had a BCVA improvement of ≥15 letters from preoperative baseline through day 90 (77.2% vs. 67.7% [ P  = 0.009] and 65.4% vs. 65.9% [ P  = 0.888]) and through day 60 (76.2% vs. 64.7% [ P  = 0.002] and 68.9% vs. 62.1% [ P  = 0.092]). No unanticipated adverse events were observed. Conclusions These studies demonstrated the clinical benefits of Nepafenac 0.3% over vehicle in reducing the risk of postoperative ME, with the integrated analysis showing improved BCVA after cataract surgery in patients with diabetic retinopathy, with no unanticipated safety events.

  • once daily Nepafenac ophthalmic suspension 0 3 to prevent and treat ocular inflammation and pain after cataract surgery phase 3 study
    Journal of Cataract and Refractive Surgery, 2014
    Co-Authors: Satish S Modi, Robert P Lehmann, Thomas R Walters, Raymond Fong, William C Christie, Lawrence Roel, David Nethery, Dana Sager, Alexis Tsorbatzoglou, Bo Philipson
    Abstract:

    Purpose To evaluate once-daily Nepafenac 0.3% to prevent and treat ocular pain and inflammation after cataract surgery. Setting Sixty-five centers in the United States and Europe. Design Randomized double-masked vehicle- and active-controlled phase 3 study. Methods Patients received Nepafenac 0.3% once daily, Nepafenac 0.1% 3 times daily, or their respective vehicles from day −1 to day 14 after cataract extraction. An additional drop of study drug was administered 30 to 120 minutes preoperatively. The primary endpoint was the percentage of patients with a cure for inflammation (score of 0 for both aqueous cells and flare) at day 14. Results Of randomized patients, 817 received Nepafenac 0.3%, 819 received Nepafenac 0.1%, and 200 and 206 received the respective vehicles. Significantly more Nepafenac 0.3% patients had no inflammation (68.4% versus 34.0%) and were pain free (91.0% versus 49.7%) at day 14 than vehicle patients (both P P ≤.0012) and more clinical successes ( P ≤.0264) were observed with Nepafenac 0.3% versus vehicle. Nepafenac 0.3% was well tolerated and had a safety profile comparable to that of Nepafenac 0.1%. Conclusions Once-daily Nepafenac 0.3% was noninferior to Nepafenac 0.1% 3 times daily for prevention and treatment of ocular inflammation and pain following cataract surgery. The safety of Nepafenac 0.3% was comparable to that of Nepafenac 0.1%, with the added convenience of once-daily dosing. Financial Disclosure Drs. Modi, Lehmann, Walters, Fong, Christie, Roel, Nethery, and Reiser have been paid consultants to Alcon Research, Ltd. Ms. Sager is an employee of Alcon Research, Ltd. Drs. Tsorbatzoglou, Philipson, and Traverso have no financial or proprietary interest in any material or method mentioned.

  • Nepafenac ophthalmic suspension 0 1 for the prevention and treatment of ocular inflammation associated with cataract surgery
    Journal of Cataract and Refractive Surgery, 2007
    Co-Authors: Stephen S Lane, Satish S Modi, Robert Lehmann, Edward J Holland
    Abstract:

    Purpose To determine whether Nepafenac ophthalmic suspension 0.1% decreases the incidence and severity of inflammation and pain after cataract surgery with posterior chamber intraocular lens implantation. Setting Twenty-one ophthalmology clinics in the United States. Methods A randomized double-blind vehicle-controlled trial was conducted in which adult patients were randomly assigned to receive Nepafenac 0.1% or vehicle beginning 1 day before surgery and continuing on the day of surgery (day 0) for 14 days. Patients were evaluated on days 1, 3, 7, and 14. The primary efficacy variable was the percentage of patients cured at day 14 (cure defined as aqueous cells score + aqueous flare score=0). Other efficacy variables included percentage of patients who were pain free at all visits and aqueous cells, flare, and cells plus flare scores. Results The mean age of the 476 patients (243 Nepafenac, 233 vehicle) was 70 years (range 27 to 93 years). At day 14, 152 patients (62.6%) in the Nepafenac group and 40 (17.2%) in the vehicle group were cured ( P P P Conclusion Nepafenac ophthalmic suspension 0.1% was safe and effective for preventing and treating ocular inflammation and pain associated with cataract surgery.

Tumay Orsel - One of the best experts on this subject based on the ideXlab platform.

  • comparison of subtenon triamcinolone acetonide injection with topical Nepafenac for the treatment of pseudophakic cystoid macular edema
    Ocular Immunology and Inflammation, 2017
    Co-Authors: Bora Yuksel, Umut Duygu Uzunel, Suleyman Gokhan Kerci, Levent Sagban, Tuncay Kusbeci, Tumay Orsel
    Abstract:

    ABSTRACTPurpose: To compare the efficacy and safety of subtenon triamcinolone acetonide (TA) injection with topical Nepafenac 0.1% for the treatment of pseudophakic cystoid macular edema (CME).Methods: In this prospective study, the TA group comprised 24 eyes and the Nepafenac group 24 eyes. Best-corrected visual acuity (BCVA), central retinal thickness (CRT), intraocular pressure measurements, and slit-lamp fundoscopy were performed in all subjects at baseline, 1, 2, 3, and 6 months.Results: Changes in BCVA and CRT over four follow-up visits were statistically significant (p<0.001). The mean CRT decreased from 513.3 to 318.9 μm in the TA group and from 483.7 to 278.0 μm in the Nepafenac group. This reduction was statistically significant (p<0.001 for both groups).Conclusions: Our visual and OCT results suggest that both treatment modalities are effective with few side-effects. However, Nepafenac is more efficacious than subtenon TA in terms of visual gain and its correlation with the reduction in CRT.

  • Comparison of Subtenon Triamcinolone Acetonide Injection with Topical Nepafenac for the Treatment of Pseudophakic Cystoid Macular Edema.
    Ocular Immunology and Inflammation, 2016
    Co-Authors: Bora Yuksel, Umut Duygu Uzunel, Suleyman Gokhan Kerci, Levent Sagban, Tuncay Kusbeci, Tumay Orsel
    Abstract:

    ABSTRACTPurpose: To compare the efficacy and safety of subtenon triamcinolone acetonide (TA) injection with topical Nepafenac 0.1% for the treatment of pseudophakic cystoid macular edema (CME).Methods: In this prospective study, the TA group comprised 24 eyes and the Nepafenac group 24 eyes. Best-corrected visual acuity (BCVA), central retinal thickness (CRT), intraocular pressure measurements, and slit-lamp fundoscopy were performed in all subjects at baseline, 1, 2, 3, and 6 months.Results: Changes in BCVA and CRT over four follow-up visits were statistically significant (p

Rishi P Singh - One of the best experts on this subject based on the ideXlab platform.

  • Nepafenac 0 3 after cataract surgery in patients with diabetic retinopathy results of 2 randomized phase 3 studies
    Ophthalmology, 2017
    Co-Authors: Rishi P Singh, Alexis Tsorbatzoglou, Robert Lehmann, Giovanni Staurenghi, Ayala Pollack, Joseph N Martel, Kevin Jong, Guadalupe Cervantescoste Cervantes, Louis Alpern, Satish S Modi
    Abstract:

    Purpose To demonstrate the efficacy and safety of once-daily Nepafenac 0.3% ophthalmic suspension versus vehicle, based on clinical outcomes, after cataract surgery in patients with diabetes. Design Two prospective, randomized, multicenter, double-masked, vehicle-controlled phase 3 studies. Participants Total, 615 patients in study 1 and 605 patients in study 2. Methods Patients were randomized (1:1) to topical Nepafenac 0.3% or vehicle once-daily starting the day before surgery and continuing for 90 days thereafter. Main Outcome Measures Key efficacy variables were: patients (%) in whom macular edema (ME) developed (≥30% increase from preoperative baseline central subfield macular thickness) within 90 days after cataract surgery and the patients (%) with a best-corrected visual acuity (BCVA) improvement of ≥15 letters from preoperative baseline through day 14 maintained through day 90. Secondary end points included: patients (%) with a BCVA improvement of ≥15 letters from preoperative baseline through days 90 and 60 and safety over 3 months. Results A significantly lower percentage of patients demonstrated ME within 90 days after surgery with Nepafenac 0.3% versus vehicle (study 1: 2.3% vs. 17.3%; P P  = 0.001; pooled: 4.1% vs. 15.9%; P P P  = 0.671) in study 2, and 55.4% versus 46.7% ( P  = 0.003) in the pooled analysis. A greater percentage of patients treated with Nepafenac 0.3% versus vehicle in study 1 and similar percentage in study 2 had a BCVA improvement of ≥15 letters from preoperative baseline through day 90 (77.2% vs. 67.7% [ P  = 0.009] and 65.4% vs. 65.9% [ P  = 0.888]) and through day 60 (76.2% vs. 64.7% [ P  = 0.002] and 68.9% vs. 62.1% [ P  = 0.092]). No unanticipated adverse events were observed. Conclusions These studies demonstrated the clinical benefits of Nepafenac 0.3% over vehicle in reducing the risk of postoperative ME, with the integrated analysis showing improved BCVA after cataract surgery in patients with diabetic retinopathy, with no unanticipated safety events.

  • efficacy of Nepafenac ophthalmic suspension 0 1 in improving clinical outcomes following cataract surgery in patients with diabetes an analysis of two randomized studies
    Clinical Ophthalmology, 2017
    Co-Authors: Rishi P Singh, Dana Sager, Giovanni Staurenghi, Ayala Pollack, Adeniyi Adewale, Thomas M Walker, Robert Lehmann
    Abstract:

    OBJECTIVE: To assess the efficacy of Nepafenac 0.1% ophthalmic suspension in improving the clinical outcomes following cataract surgery (CS) in patients with nonproliferative diabetic retinopathy. METHODS: In two similar multicenter, randomized studies, patients received either Nepafenac 0.1% or vehicle, instilled three times daily starting a day prior to surgery and continuing for 90 days postoperatively. A post hoc analysis of these two studies was conducted to assess 1) the likelihood for development of postoperative macular edema (ME), based on the percentage of patients who developed ME (≥30% increase from preoperative baseline in central subfield macular thickness) within 90 days following CS and 2) best-corrected visual acuity (BCVA) endpoints, including the percentage of patients with a BCVA improvement of ≥15 letters from preoperative baseline to Day 14 and maintained through Day 90. Results for individual studies and their pooled estimates (only visual acuity endpoints) are reported. Primary inference was based on odds ratio (OR). RESULTS: This post hoc analysis included 411 patients (Nepafenac 0.1%: 205; vehicle: 206). The incidence of postoperative ME within 90 days of CS was notably lower in the Nepafenac-treated patients than in vehicle-treated patients (study 1: 3.2% vs 16.7%; OR =0.2, 95% confidence interval [CI] =0.1, 0.5, P=0.001; study 2: 5.0% vs 17.5%; OR =0.2, 95% CI =0.1, 0.8, P=0.018). A higher percentage of Nepafenac-treated patients than vehicle-treated patients gained ≥15 letters from preoperative baseline to Day 14, which was maintained through Day 90 (study 1: 38.4% vs 21.4%; OR =2.4, 95% CI =1.4, 4.2, P=0.003; study 2: 35.0% vs 25.0%; OR =1.6, 95% CI =0.8, 3.2, P=0.172; pooled: 37.1% vs 22.8%; OR =2.0, 95% CI =1.3, 3.1, P=0.001). The odds of >5-letter and >10-letter loss in BCVA from postoperative Day 7 were higher in vehicle-treated than in Nepafenac-treated patients. CONCLUSION: These results support the clinical benefit of prophylactic use of Nepafenac 0.1% for reducing the risk of postoperative ME and for improvement in BCVA outcomes following CS in patients with nonproliferative diabetic retinopathy.

  • prospective randomised clinical trial to evaluate the safety and efficacy of Nepafenac 0 1 treatment for the prevention of macular oedema associated with cataract surgery in patients with diabetic retinopathy
    British Journal of Ophthalmology, 2017
    Co-Authors: Ayala Pollack, Dana Sager, Giovanni Staurenghi, Bickol Mukesh, Harvey Reiser, Rishi P Singh
    Abstract:

    Background/aims This study evaluated Nepafenac ophthalmic suspension 0.1% for prevention of macular oedema (MO) when used 90 days following cataract surgery in patients with diabetic retinopathy (DR). Methods Randomised, double-masked, vehicle-controlled, parallel group study conducted at 32 centres across the world. Participants were patients with diabetes with non-proliferative diabetic retinopathy scheduled for cataract surgery with (posterior chamber) intraocular lens implantation. Patients were randomised to Nepafenac ophthalmic suspension 0.1% or vehicle three times daily, beginning on the day before surgery and continuing through the last study visit (day 90 or early exit). All patients were instilled one drop of tobramycin 0.3% and dexamethasone 0.1% four times daily for 2 weeks after surgery. Primary efficacy end point was the percentage of patients who developed MO (defined as ≥30% increase in central subfield macular thickness from baseline) within 90 days following surgery. The secondary end point was mean change in best-corrected visual acuity (BCVA) from baseline to day 90. Results A total of 175 patients were randomised, with 87 and 88 patients in the Nepafenac and vehicle groups, respectively. A significantly greater percentage of eyes in the vehicle group (17.5%; 95% CI 9.9% to 27.6%) developed MO within 90 days following surgery compared with the Nepafenac group (5.0%; 95% CI 1.4% to 12.3%, p=0.01). Mean change in BCVA from baseline to day 90 following surgery was greater in the Nepafenac group (17.7±14.6 letters) relative to the vehicle group (14.3±13.9 letters), though the difference was not statistically significant (p=0.14). No new safety issues or trends were identified. Conclusions A 90-day Nepafenac treatment regimen prevented MO after cataract surgery in patients with DR and demonstrated no safety issues within this study group. Trial registration number NTC00782717 and NCT00939276.