Nepafenac Once Daily for Macular Edema - Study 1
Condition: Non-Proliferative Diabetic Retinopathy; Cataract
MeSH terms: Cataract; Retinal Diseases; Diabetic Retinopathy
Intervention: Nepafenac Ophthalmic Suspension, 0.3%; Nepafenac vehicle; Prednisolone acetate
Intervention description: Test intervention; Inactive ingredients used as placebo comparator; 1 drop instilled in the operative eye 4 times daily beginning post-operatively on the day of surgery for the first 2 weeks, followed by 2 times daily for the next 2 weeks
Intervention MeSH terms: Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Nepafenac; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 881.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetes Type I; Diabetes Type II; non-proliferative diabetic retinopathy; macular edema; Cataract

Summary:

      The purpose of this study is to demonstrate superiority of Nepafenac Ophthalmic Suspension,
      0.3% dosed once daily relative to Nepafenac Vehicle based upon clinical outcomes among
      diabetic subjects following cataract surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Planned cataract extraction by phacoemulsification with implantation of a posterior
             chamber intraocular lens;

          -  History of Type 1 or 2 diabetes and non-proliferative diabetic retinopathy (NPDR)
             (mild, moderate, or severe) in the study eye;

          -  Best corrected visual acuity (BCVA) of 73 letters or worse in the study eye with
             expectation of improvement after surgery;

          -  Understand and sign an informed consent document;

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Pre-existing macular edema in the study eye;

          -  History in the study eye of retinal detachment, wet age-related macular degeneration,
             chronic or recurrent inflammatory eye disease, or prior procedures;

          -  Planned cataract surgery in the fellow eye after randomization and prior to the Day 90
             postoperative study visit or through study exit;

          -  Planned multiple procedures for the study eye during the cataract/intraocular lens
             implantation surgery;

          -  Use of exclusionary medications, including nonsteroidal anti-inflammatory drugs
             (NSAIDs) and steroids, as specified in protocol.

          -  Participation in any other clinical study within 30 days of the screening visit;

          -  Females of childbearing potential who are breast feeding, have a positive urine
             pregnancy test at screening, are not willing to undergo a urine pregnancy test upon
             entering or exiting the study, intend to become pregnant during the study, or do not
             agree to use adequate birth control methods for the duration of the study;

          -  Other protocol-defined exclusion criteria may apply.