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

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.

Study Overview

• Status: Terminated
• Conditions: Macular Edema; Macular Thickening
• Intervention / Treatment: Drug: Nepafenac; Other: Lubricant

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 004030
    • Asociación para Evitar la Ceguera en México I.A.P.
  • Mexico City, Mexico, 04030
    • Asociación para Evitar la Ceguera en México I.A.P.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1: 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.	Drug: 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.; Other Names: Nevanac 0.1%
Placebo Comparator: 2: placebo; 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	Other: 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; Other Names: Systane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Central macular thickening	2 weeks after each laser session and 1 and 2 months after last laser session

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Asociación para Evitar la Ceguera en México
• Investigators: Principal Investigator: Dulce O Rascon-Vargas, Fellow, Asociación para Evitar la Ceguera en México I.A.P.; Study Chair: Guadalupe Cervantes-Coste, Asociación para Evitar la Ceguera en México I.A.P.; Study Director: Jans Fromow-Guerra, Asociación para Evitar la Ceguera en México I.A.P.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: December 3, 2008
• First Submitted That Met QC Criteria: December 3, 2008
• First Posted (Estimated): December 4, 2008

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 29, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Macular edema; Macular thickening; Pan-retinal photocoagulation; Nepafenac; Topical non-steroidal anti inflammatory agents
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Nepafenac
• Other Study ID Numbers: NEPAFENAC IN PRFC; NEPAFENACO