A Clinical Safety and Efficacy Comparison of NEVANAC® 0.1% to Vehicle Following Cataract Surgery in Diabetic Retinopathy Patients - Macular Edema Incidence/Severity Reduction with NEVANAC®

Active, not recruiting

• Conditions: macular edema following cataract surgery; MedDRA version: 9.1Level: LLTClassification code 10051240Term: Cystoid macular edema; MedDRA version: 9.1Level: LLTClassification code 10054467Term: Macular edema

• Registration Number: EUCTR2009-010536-17-NL
• Lead Sponsor: ALCON RESEARCH, LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-03
• Last Update Posted: 29 May 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

1)Patients must be 18 years of age and older, of any race and either sex, who have a cataract, and are planning to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens into the lens capsule
2)History of Type 1 or Type 2 diabetes
3)NPDR (mild, moderate or severe) in the study eye as defined by the International Clinical Diabetic Retinopathy Disease Severity Scale

4)Central subfield macular thickness = 320 µm in the study eye prior to cataract surgery as determined by SD-OCT and confirmed by the reading center
5)Absence of CME or cystoid abnormalities in the study eye as detected by SD-OCT and confirmed by the reading center
6)Absence of clinically significant macular edema (CSME) in the study eye as detected by clinical exam

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusions related to patient history or current ocular conditions:
4)Signs of vitreomacular traction or epiretinal membrane in the study eye as detected by SD-OCT or fundus exam per reading center or investigator
5)Current or previous ocular disease in the study eye that in the opinion of the investigator may confound assessment of the macula, the retina, or central vision, other that diabetic retinopathy, such as retinal vascular disease, macular surgery, retinal detachment involving the macula, wet macular degeneration or geographic atrophy in the study eye
6)Prior focal photocoagulation for the treatment of diabetic macular edema in the study eye within 6 months of the pre-operative baseline visit (Note: peripheral retina treatment for retinal tear or lattice degeneration is permitted)
7)Prior panretinal photocoagulation in the study eye
8)Planned multiple procedures for study eye during the cataract/IOL implantation surgery (e.g., trabeculoplasty, corneal transplant)
9)Patients who have received corneal transplants in the study eye
10)Use of daily doses of topical ocular NSAIDs (Voltaren, Acular LS, etc.), in the study eye, within 7 days prior to surgery
11)Use of daily doses of systemic NSAIDs (ibuprofen, naproxen, etc.) within 7 days prior to surgery (through study exit), with the exception of 325 mg of aspirin which will be allowed during the study.
12)Use of systemic steroids within 14 days prior to surgery (through study exit)
13)Use of daily doses of topical ocular NSAIDs (Voltaren, Acular LS, etc.) in the nonstudy eye through study exit (Note: All topical ocular NSAIDs must be discontinued 1 day prior to surgery)
14)Use of daily doses of topical ocular steroids in the nonstudy eye through study exit (Note: All topical ocular steroids must be discontinued 1 day prior to surgery)
15)Use of topical ocular steroids, in the study eye, within 14 days prior to surgery
16)Treatment with intraocular or periocular steroids in the study eye within 6 months prior to surgery

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Demonstrate superiority of NEVANAC® (nepafenac ophthalmic suspension) 0.1% relative to nepafenac vehicle based on the percentage of diabetic retinopathy patients who develop macular edema (defined as =30% increase from pre-operative baseline in central subfield macular thickness) within 90 days following cataract surgery.;Secondary Objective: not applicable;Primary end point(s): percentage of patients who develop macular edema (defined as =30% increase from pre-operative baseline in central subfield macular thickness) within 90 days following cataract surgery