Macular Edema Incidence/Severity Reduction With Nevanac

October 18, 2012 updated by: Alcon Research
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

175

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76134
        • Contact Alcon Call Center for Trial Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 μm 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NEVANAC
One drop instilled in the study eye 3 times daily (morning, midafternoon, and bedtime) beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery
Drug: Nepafenac ophthalmic suspension, 0.1% (NEVANAC®)
One drop instilled in the study eye 3 times daily (morning, midafternoon, and bedtime) beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery
Other Names:
  • NEVANAC®
Placebo Comparator: Nepafenac Vehicle
One drop instilled in the study eye 3 times daily (morning, midafternoon, and bedtime) beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery
Drug: Nepafenac ophthalmic suspension vehicle
One drop instilled in the study eye 3 times daily (morning, midafternoon, and bedtime) beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients who develop macular edema within 90 days following cataract surgery
Time Frame: Time to event
Time to event

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean change in best-corrected visual acuity (BCVA) from baseline to Day 90
Time Frame: Baseline, Day 90
Baseline, Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

July 10, 2009

First Submitted That Met QC Criteria

July 13, 2009

First Posted (Estimate)

July 14, 2009

Study Record Updates

Last Update Posted (Estimate)

October 23, 2012

Last Update Submitted That Met QC Criteria

October 18, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-09-003
  • EudraCT Number: 2009-010536-17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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