---
title: Effect of Topical Nepafenac in Macular Thickening Related to Pan-retinal Photocoagulation
nct_id: NCT00801905
overall_status: TERMINATED
phase: PHASE2
sponsor: Asociación para Evitar la Ceguera en México
study_type: INTERVENTIONAL
primary_condition: Macular Thickening
countries: Mexico
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00801905.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00801905"
ct_last_update_post_date: 2024-05-30
last_seen_at: "2026-05-12T06:21:30.188Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effect of Topical Nepafenac in Macular Thickening Related to Pan-retinal Photocoagulation

**NCT ID:** [NCT00801905](https://clinicaltrials.gov/study/NCT00801905)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** undefined
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 50
- **Lead Sponsor:** Asociación para Evitar la Ceguera en México
- **Conditions:** Macular Thickening, Macular Edema
- **Start Date:** 2008-08
- **Completion Date:** 2009-03
- **CT.gov Last Update:** 2024-05-30

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **1: Nepafenac** (ACTIVE_COMPARATOR) — 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** (PLACEBO_COMPARATOR) — 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

## Interventions

- **Nepafenac** (DRUG) — 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.
- **Lubricant** (OTHER) — 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 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)_

## 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

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.asociación para evitar la ceguera en méxico i.a.p.|mexico city||mexico` — added _(2026-05-12)_
- `locations.asociacion para evitar la ceguera en mexico i.a.p.|mexico city||mexico` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00801905.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00801905*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*