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

Phase 2

Terminated

• Conditions: Macular Thickening; Macular Edema
• Interventions: Drug: Nepafenac; Other: Lubricant

• Registration Number: NCT00801905
• Lead Sponsor: Asociación para Evitar la Ceguera en México

Brief 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.

Detailed 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 Timeline

• Study Start: 2008-08
• Primary Completion: 2008-12
• Study First Submitted: 2008-12-03
• Study First Submitted QC: 2008-12-03
• Study First Posted: 2008-12-04
• Study Completion: 2009-03
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients with Severe and proliferative Diabetic Retinopathy
• Symmetric severity grade on both eyes
• Best corrected visual acuity better than 20/80

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1: Nepafenac	Nepafenac	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.
2: placebo	Lubricant	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

Primary Outcome Measures

Name	Time	Method
Central macular thickening	2 weeks after each laser session and 1 and 2 months after last laser session

Secondary Outcome Measures

Name	Time	Method
Best corrected visual acuity	2 weeks after each laser session, 1, 2 and 3 months after pan-retinal photocoagulation is completed

Trial Locations

Locations (2)

Asociacion para Evitar la Ceguera en Mexico I.A.P.; 🇲🇽 Mexico City, Mexico

Asociación Para Evitar la Ceguera en México I.A.P.; 🇲🇽 Mexico City, Mexico