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

Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Macular Edema

Intervention: Nepafenac ophthalmic suspension, 0.1% (NEVANAC) (Drug); Nepafenac ophthalmic suspension vehicle (Other); Prednisolone acetate ophthalmic suspension (OMNIPRED) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Alcon Research

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.

Clinical Details

Official title: A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle Following Cataract Surgery in Diabetic Retinopathy Patients

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery

Secondary outcome: Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA).

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Additional Information

Starting date: November 2008
Last updated: October 22, 2012

Page last updated: August 23, 2015

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