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Effect of Topical Nepafenac in Macular Thickening Related to Pan-retinal Photocoagulation — NEPAF  

Macular Edema Clinical Trial

Official title:
Effect of Topical Nepafenac in Macular Thickening Related to Pan-retinal Photocoagulation

Clinical Trial Summary

The purpose of this study is to determine whether topical nepafenac (qid) is effective in preventing and treating macular thickening related pan-retinal photocoagulation in patients with diabetic retinopathy.

Clinical Trial Description

Objective: To evaluate the effect of topical nepafenac 0.1 %, in preventing and in treating macular thickening related to pan-retinal photocoagulation in diabetic patients. Material and methods: This is a prospective, longitudinal, and controlled study in patients with diabetic retinopathy (severe non-proliferative and proliferative retinopathy), with a symmetric severity in both eyes and without a clinical significant macular edema. The best corrected visual acuity (BCVA) in all patients was 20/80 or better. All patients will undergo pan-retinal photocoagulation in three different sessions (with 2 weeks in apart between them). Each patient will receive topical nepafenac 0.1% (qid) on one eye, and placebo (qid) at the fellow eye, starting 1 week before the first retinal photocoagulation session and continued for 9 weeks ( ending 4 weeks after pan-retinal photocoagulation is completed). Spectral domain OCT and BCVA in ETDRS scale will be performed before and at 2 weeks after each laser session, and at 1, 2 and 3 months after treatment completed. BCVA and OCT outcomes of each studied period will be compared on both eyes, and side effects will be recorded. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00801905
Study type Interventional
Source Asociación para Evitar la Ceguera en México
Contact
Status Terminated
Phase Phase 2
Start date August 2008
Completion date March 2009
View Details
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