Macular Edema Incidence/Severity Reduction With Nevanac

Phase 3 Terminated 175 enrolled Alcon Research

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate NEVANAC in patients with diabetic retinopathy who developed macular edema (ME) within 90 days following cataract surgery.

Timeline

Start: 2009-08
Primary completion: 2011-05
Completion: 2011-08

Outcome

Met primary endpoint

Stopped (Enrollment): “Patient recruitment difficulties”

paper 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). PMID 27388251 ↗

Publications

Pollack A, Staurenghi G, Sager D, Mukesh B, Reiser H, Singh RP. 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. Br J Ophthalmol. 2017 Apr;101(4):423-427. doi: 10.1136/bjophthalmol-2016-308617. Epub 2016 Jul 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nepafenac	Other / unclassified	0.1 %	Topical