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

Phase 2

Completed

• Conditions: Macular Edema
• Interventions: Drug: Nepafenac ophthalmic suspension, 0.1% (NEVANAC); Other: Nepafenac ophthalmic suspension vehicle; Drug: Prednisolone acetate ophthalmic suspension (OMNIPRED)

• Registration Number: NCT00782717
• Lead Sponsor: Alcon Research

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

Not available

Study Timeline

• Study First Submitted: 2008-10-29
• Study First Submitted QC: 2008-10-29
• Study First Posted: 2008-10-31
• Study Start: 2008-11
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Results First Submitted: 2011-08-17
• Results First Submitted QC: 2011-08-17
• Results First Posted: 2011-09-21
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-22
• Last Update Posted: 2012-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 263

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NEVANAC	Nepafenac ophthalmic suspension, 0.1% (NEVANAC)	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.
NEVANAC	Prednisolone acetate ophthalmic suspension (OMNIPRED)	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.
Nepafenac Vehicle	Nepafenac ophthalmic suspension vehicle	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.
Nepafenac Vehicle	Prednisolone acetate ophthalmic suspension (OMNIPRED)	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.

Primary Outcome Measures

Name	Time	Method
Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery	3 Months	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).

Secondary Outcome Measures

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