Phase 2
Completed N=263
A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle After Cataract Surgery in Diabetic Retinopathy Patients
Source: ClinicalTrials.gov NCT00782717 ↗Enrolled (actual)
263
Serious AEs
5.1%
Results posted
Sep 2011
Primary outcomePrimary: Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery — 3; 17 Percentage of patients
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery |
3; 17 | — |
| SECONDARY Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA). |
6; 12 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00782717). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.