A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle After Cataract Surgery in Diabetic Retinopathy Patients

Study Overview
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Brief Summary
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The purpose of this study is to determine whether nepafenac is safe and effective for reducing the incidence of macular edema following cataract surgery in diabetic retinopathy patients.

Official Title
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A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle Following Cataract Surgery in Diabetic Retinopathy Patients

Conditions
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Macular Edema

Intervention / Treatment
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* Drug: Nepafenac ophthalmic suspension, 0.1% (NEVANAC)
* Other: Nepafenac ophthalmic suspension vehicle
* Drug: Prednisolone acetate ophthalmic suspension (OMNIPRED)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with non-proliferative diabetic retinopathy (mild, moderate or severe) and planned cataract extraction by phacoemulsification. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Central subfiled macular thickness greater than or equal to 250 microns CME in either eye. Other protocol-defined exclusion criteria may apply.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NEVANAC<br>One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter. | Drug: Nepafenac ophthalmic suspension, 0.1% (NEVANAC)<br>* 1 drop TID beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery.<br>* Other names: NEVANAC;Drug: Prednisolone acetate ophthalmic suspension (OMNIPRED)<br>* One drop in the study eye 4 times daily (morning, late morning, late afternoon, and bedtime)for two weeks postsurgery.<br>* Other names: OMNIPRED;|
| Placebo Comparator: Nepafenac Vehicle<br>One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter. | Other: Nepafenac ophthalmic suspension vehicle<br>* 1 drop TID beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery<br>Drug: Prednisolone acetate ophthalmic suspension (OMNIPRED)<br>* One drop in the study eye 4 times daily (morning, late morning, late afternoon, and bedtime)for two weeks postsurgery.<br>* Other names: OMNIPRED;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery | Macular edema (thickening of the center of the back of the eye) was defined as 30% or greater increase from pre-operative baseline measurement in central subfield macular thickness as measured using Optical Coherence Tomography(OCT). | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA). | BCVA was measured using the procedure developed for the Early Treatment Diabetic Retinopathy Study. | From Day 7 to Day 90 (or Early Exit) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic retinopathy, cystoid macular edema;