Macular Edema Incidence/Severity Reduction With Nevanac

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate NEVANAC in patients with diabetic retinopathy who developed macular edema (ME) within 90 days following cataract surgery.

Conditions
-----------------
Diabetic Retinopathy

Intervention / Treatment
-----------------
* Drug: Nepafenac ophthalmic suspension, 0.1% (NEVANAC®)
* Drug: Nepafenac ophthalmic suspension vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens (IOL) into the lens capsule. History of Type 1 or Type 2 diabetes. History of nonproliferative diabetic retinopathy (NPDR), mild, moderate, or severe, in the study eye as defined by the International Clinical Diabetic Retinopathy Disease Severity Scale. Able to understand and sign an informed consent approved by an IRB/IEC. Central subfield macular thickness less than or equal to 320 μm in the study eye prior to cataract surgery. Absence of clinically significant macular edema in the study eye as detected by clinical exam. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Signs of vitreomacular traction or epiretinal membrane in the study eye as detected by the reading center or Investigator. Current or previous ocular disease other than diabetic retinopathy in the study eye that, in the opinion of the Investigator, would have confounded the assessments of the macula, the retina, or central vision. Planned multiple procedures for the study eye during the cataract/IOL implantation surgery (eg, trabeculoplasty, corneal transplant). Corneal transplant in study eye. Baseline cumulative corneal fluorescein staining score (ie, sum of scores for all 5 corneal regions) for the study eye greater than or equal to 5, or baseline corneal fluorescein staining score in any single region for the study eye greater than or equal to 3. Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NEVANAC<br>One drop instilled in the study eye 3 times daily (morning, midafternoon, and bedtime) beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery | Drug: Nepafenac ophthalmic suspension, 0.1% (NEVANAC®)<br>* One drop instilled in the study eye 3 times daily (morning, midafternoon, and bedtime) beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery<br>* Other names: NEVANAC®;|
| Placebo Comparator: Nepafenac Vehicle<br>One drop instilled in the study eye 3 times daily (morning, midafternoon, and bedtime) beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery | Drug: Nepafenac ophthalmic suspension vehicle<br>* One drop instilled in the study eye 3 times daily (morning, midafternoon, and bedtime) beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who develop macular edema within 90 days following cataract surgery |  | Time to event | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in best-corrected visual acuity (BCVA) from baseline to Day 90 |  | Baseline, Day 90 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cataract surgery, macular edema, prevention