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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Topical Nepafenac in Macular Thickening Related to Pan-Retinal Photocoagulation

Conditions
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Macular Thickening, Macular Edema

Intervention / Treatment
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* Drug: Nepafenac
* Other: Lubricant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1: Nepafenac<br>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<br>* 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.<br>* Other names: Nevanac 0.1%;|
| Placebo Comparator: 2: placebo<br>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<br>* 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<br>* Other names: Systane;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Macular thickening, Macular edema, Pan-retinal photocoagulation, Nepafenac, Topical non-steroidal anti inflammatory agents