Conditions: Macular Edema
Keywords: diabetic retinopathy cystoid macular edema;
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 263
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: Nepafenac ophthalmic suspension, 0.1% (NEVANAC) intervention 2: Nepafenac ophthalmic suspension vehicle intervention 3: Prednisolone acetate ophthalmic suspension (OMNIPRED)
Intervention descriptions: intervention 1: 1 drop TID beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery. intervention 2: 1 drop TID beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery intervention 3: One drop in the study eye 4 times daily (morning, late morning, late afternoon, and bedtime)for two weeks postsurgery.

Protocol document: