Status:

COMPLETED

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

Lead Sponsor:

Alcon Research

Conditions:

Macular Edema

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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.

Eligibility Criteria

Inclusion

  • Patients with non-proliferative diabetic retinopathy (mild, moderate or severe) and planned cataract extraction by phacoemulsification.
  • Other protocol-defined inclusion criteria may apply.

Exclusion

  • Central subfiled macular thickness greater than or equal to 250 microns
  • CME in either eye.
  • Other protocol-defined exclusion criteria may apply.

Key Trial Info

Start Date :

November 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2010

Estimated Enrollment :

263 Patients enrolled

Trial Details

Trial ID

NCT00782717

Start Date

November 1 2008

End Date

July 1 2010

Last Update

October 26 2012

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