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

Phase 2TerminatedNCT00801905

Asociación para Evitar la Ceguera en México50 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Macular Thickening Macular Edema

Interventions

NepafenacDRUG

Topical nepafenac 0.1% is administrated every 6 hour 1 week before start pan-retinal photocoagulation and 4 weeks during all laser session performed biweekly, and 4 weeks after last laser sessión was completed.

LubricantOTHER

Topical lubricating is administrated every 6 hours at fellow eye 1 week before start pan-retinal photocoagulation, 4 weeks during each laser session performed biweekly, and 4 weeks after last laser sessión was completed

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with Severe and proliferative Diabetic Retinopathy * Symmetric severity grade on both eyes * Best corrected visual acuity better than 20/80 Exclusion Criteria: * Clinical significant macular edema * Lens opacity * Ocular surgery 6 months or less before recruit * Uveitis history * Actual use of topical or systemic non-steroidal anti inflammatory agents * Actual or history of other macular diseases * Ocular surface diseases * Vitreomacular traction syndrome * Other vascular retinal diseases different to diabetic retinopathy * Actual or history of use of topical prostaglandin analogues

Locations (2)

Asociación Para Evitar la Ceguera en México I.A.P.

Mexico City, Mexico

Asociacion para Evitar la Ceguera en Mexico I.A.P.

Mexico City, Mexico

Outcomes

Primary Outcomes

Central macular thickening

Time frame: 2 weeks after each laser session and 1 and 2 months after last laser session

Secondary Outcomes

Best corrected visual acuity

Time frame: 2 weeks after each laser session, 1, 2 and 3 months after pan-retinal photocoagulation is completed

Data from ClinicalTrials.gov

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