Evaluation of nepafenac in prevention of macular edema following cataract surgery in patients with diabetic retinopathy

Rishi Singh,1 Louis Alpern,2 Glenn J Jaffe,3 Robert P Lehmann,4 John Lim,5 Harvey J Reiser,6 Kenneth Sall,7 Thomas Walters,8 Dana Sager91Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, OH, 2The Cataract, Glaucoma, and Refractive Surgery Center, El Paso, TX, 3Duke Eye Center, Duke Reading...

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Autores principales:	Singh R, Alpern L, Jaffe GJ, Lehmann RP, Lim J, Reiser HJ, Sall K, Walters T, Sager D
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2012
Materias:	Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/68e55cef097947b2af6c0e2cb449dc7a
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spelling	oai:doaj.org-article:68e55cef097947b2af6c0e2cb449dc7a2021-12-02T07:40:26ZEvaluation of nepafenac in prevention of macular edema following cataract surgery in patients with diabetic retinopathy1177-54671177-5483https://doaj.org/article/68e55cef097947b2af6c0e2cb449dc7a2012-08-01T00:00:00Zhttp://www.dovepress.com/evaluation-of-nepafenac-in-prevention-of-macular-edema-following-catar-a10604https://doaj.org/toc/1177-5467https://doaj.org/toc/1177-5483Rishi Singh,1 Louis Alpern,2 Glenn J Jaffe,3 Robert P Lehmann,4 John Lim,5 Harvey J Reiser,6 Kenneth Sall,7 Thomas Walters,8 Dana Sager91Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, OH, 2The Cataract, Glaucoma, and Refractive Surgery Center, El Paso, TX, 3Duke Eye Center, Duke Reading Center, Duke University, Durham, NC, 4Lehmann Eye Center, Nacogdoches, TX, 5Houston Eye Associates, Houston, TX, 6Eye Care Specialists, Kingston, PA, 7Sall Research Medical Center, Artesia, CA, 8Texan Eye, Austin, TX, 9Alcon Research Ltd, Fort Worth, TX, USABackground: The purpose of this study was to evaluate nepafenac ophthalmic suspension 0.1% (Nevanac&reg;; Alcon Research Ltd) in the prevention of macular edema following cataract surgery in diabetic retinopathy patients.Methods: This was a multicenter, randomized, double-masked, vehicle-controlled study of 263 adult diabetic patients with nonproliferative diabetic retinopathy requiring cataract surgery. Patients were randomized (1:1) to instill nepafenac or vehicle three times daily beginning 1 day prior to surgery through day 90. Efficacy included the percentage of patients who developed macular edema (&ge;30% increase in central subfield macular thickness from baseline) and the percentage of patients with decreases of more than five letters in best-corrected visual acuity from day 7 to 90.Results: A significantly lower percentage of patients in the nepafenac group developed macular edema relative to patients in the vehicle group (3.2% versus 16.7%; P &lt; 0.001). A significantly lower percentage of patients in the nepafenac group had best-corrected visual acuity decreases of more than five letters relative to patients in the vehicle group on day 30 (P &lt; 0.001), day 60 (P = 0.002), and day 90 (P = 0.006). The mean central subfield macular thickness and mean percent change from baseline in macular volume were also significantly lower in the nepafenac group versus the vehicle group at days 14 through 90 (P &le; 0.005). No safety issues or trends were identified when dosing was increased to 90 days that negatively impacted the favorable benefit/risk profile of nepafenac.Conclusion: Nepafenac demonstrated statistically significant and clinically relevant advantages compared with vehicle in preventing macular edema and maintaining visual acuity in diabetic patients following cataract surgery. These advantages were seen at multiple time points over the course of the 90-day therapy period. There was no clinically relevant increase in risk from 90 days dosing compared with 14 days. Therefore, with a similar safety profile and benefit in preventing macular edema and maintaining vision, the risk/benefit to the diabetic patient undergoing cataract surgery appears to be positive.Keywords: cataract extraction, diabetes, macular edema, nonsteroidal anti-inflammatory drug, topical, ocular surgery, retinopathySingh RAlpern LJaffe GJLehmann RPLim JReiser HJSall KWalters TSager DDove Medical PressarticleOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2012, Iss default, Pp 1259-1269 (2012)
institution	DOAJ
collection	DOAJ
language	EN
topic	Ophthalmology RE1-994
spellingShingle	Ophthalmology RE1-994 Singh R Alpern L Jaffe GJ Lehmann RP Lim J Reiser HJ Sall K Walters T Sager D Evaluation of nepafenac in prevention of macular edema following cataract surgery in patients with diabetic retinopathy
description	Rishi Singh,1 Louis Alpern,2 Glenn J Jaffe,3 Robert P Lehmann,4 John Lim,5 Harvey J Reiser,6 Kenneth Sall,7 Thomas Walters,8 Dana Sager91Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, OH, 2The Cataract, Glaucoma, and Refractive Surgery Center, El Paso, TX, 3Duke Eye Center, Duke Reading Center, Duke University, Durham, NC, 4Lehmann Eye Center, Nacogdoches, TX, 5Houston Eye Associates, Houston, TX, 6Eye Care Specialists, Kingston, PA, 7Sall Research Medical Center, Artesia, CA, 8Texan Eye, Austin, TX, 9Alcon Research Ltd, Fort Worth, TX, USABackground: The purpose of this study was to evaluate nepafenac ophthalmic suspension 0.1% (Nevanac&reg;; Alcon Research Ltd) in the prevention of macular edema following cataract surgery in diabetic retinopathy patients.Methods: This was a multicenter, randomized, double-masked, vehicle-controlled study of 263 adult diabetic patients with nonproliferative diabetic retinopathy requiring cataract surgery. Patients were randomized (1:1) to instill nepafenac or vehicle three times daily beginning 1 day prior to surgery through day 90. Efficacy included the percentage of patients who developed macular edema (&ge;30% increase in central subfield macular thickness from baseline) and the percentage of patients with decreases of more than five letters in best-corrected visual acuity from day 7 to 90.Results: A significantly lower percentage of patients in the nepafenac group developed macular edema relative to patients in the vehicle group (3.2% versus 16.7%; P &lt; 0.001). A significantly lower percentage of patients in the nepafenac group had best-corrected visual acuity decreases of more than five letters relative to patients in the vehicle group on day 30 (P &lt; 0.001), day 60 (P = 0.002), and day 90 (P = 0.006). The mean central subfield macular thickness and mean percent change from baseline in macular volume were also significantly lower in the nepafenac group versus the vehicle group at days 14 through 90 (P &le; 0.005). No safety issues or trends were identified when dosing was increased to 90 days that negatively impacted the favorable benefit/risk profile of nepafenac.Conclusion: Nepafenac demonstrated statistically significant and clinically relevant advantages compared with vehicle in preventing macular edema and maintaining visual acuity in diabetic patients following cataract surgery. These advantages were seen at multiple time points over the course of the 90-day therapy period. There was no clinically relevant increase in risk from 90 days dosing compared with 14 days. Therefore, with a similar safety profile and benefit in preventing macular edema and maintaining vision, the risk/benefit to the diabetic patient undergoing cataract surgery appears to be positive.Keywords: cataract extraction, diabetes, macular edema, nonsteroidal anti-inflammatory drug, topical, ocular surgery, retinopathy
format	article
author	Singh R Alpern L Jaffe GJ Lehmann RP Lim J Reiser HJ Sall K Walters T Sager D
author_facet	Singh R Alpern L Jaffe GJ Lehmann RP Lim J Reiser HJ Sall K Walters T Sager D
author_sort	Singh R
title	Evaluation of nepafenac in prevention of macular edema following cataract surgery in patients with diabetic retinopathy
title_short	Evaluation of nepafenac in prevention of macular edema following cataract surgery in patients with diabetic retinopathy
title_full	Evaluation of nepafenac in prevention of macular edema following cataract surgery in patients with diabetic retinopathy
title_fullStr	Evaluation of nepafenac in prevention of macular edema following cataract surgery in patients with diabetic retinopathy
title_full_unstemmed	Evaluation of nepafenac in prevention of macular edema following cataract surgery in patients with diabetic retinopathy
title_sort	evaluation of nepafenac in prevention of macular edema following cataract surgery in patients with diabetic retinopathy
publisher	Dove Medical Press
publishDate	2012
url	https://doaj.org/article/68e55cef097947b2af6c0e2cb449dc7a
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Evaluation of nepafenac in prevention of macular edema following cataract surgery in patients with diabetic retinopathy

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