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Macular Edema Incidence/Severity Reduction With Nevanac

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

Condition(s) targeted: Diabetic Retinopathy

Intervention: Nepafenac ophthalmic suspension, 0.1% (NEVANAC®) (Drug); Nepafenac ophthalmic suspension vehicle (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Alcon Research

Summary

The purpose of this study is to evaluate NEVANAC in patients with diabetic retinopathy who developed macular edema (ME) within 90 days following cataract surgery.

Clinical Details

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

Primary outcome: Percentage of patients who develop macular edema within 90 days following cataract surgery

Secondary outcome: Mean change in best-corrected visual acuity (BCVA) from baseline to Day 90

Eligibility

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

Criteria:

Inclusion Criteria:

- Planned cataract extraction by phacoemulsification with the implantation of a

posterior chamber intraocular lens (IOL) into the lens capsule.

- History of Type 1 or Type 2 diabetes.

- History of nonproliferative diabetic retinopathy (NPDR), mild, moderate, or severe,

in the study eye as defined by the International Clinical Diabetic Retinopathy Disease Severity Scale.

- Able to understand and sign an informed consent approved by an IRB/IEC.

- Central subfield macular thickness less than or equal to 320 ╬╝m in the study eye

prior to cataract surgery.

- Absence of clinically significant macular edema in the study eye as detected by

clinical exam.

- Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

- Signs of vitreomacular traction or epiretinal membrane in the study eye as detected

by the reading center or Investigator.

- Current or previous ocular disease other than diabetic retinopathy in the study eye

that, in the opinion of the Investigator, would have confounded the assessments of the macula, the retina, or central vision.

- Planned multiple procedures for the study eye during the cataract/IOL implantation

surgery (eg, trabeculoplasty, corneal transplant).

- Corneal transplant in study eye.

- Baseline cumulative corneal fluorescein staining score (ie, sum of scores for all 5

corneal regions) for the study eye greater than or equal to 5, or baseline corneal fluorescein staining score in any single region for the study eye greater than or equal to 3.

- Other protocol-defined exclusion criteria may apply.

Locations and Contacts

Contact Alcon Call Center For Trial Locations, Fort Worth, Texas 76134, United States
Additional Information

Starting date: August 2009
Last updated: October 18, 2012

Page last updated: August 23, 2015

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