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

October 22, 2012 updated by: Alcon Research

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

263

Phase

  • Phase 2

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NEVANAC
One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
Drug: Nepafenac ophthalmic suspension, 0.1% (NEVANAC)
1 drop TID beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery.
Other Names:
  • NEVANAC
Drug: Prednisolone acetate ophthalmic suspension (OMNIPRED)
One drop in the study eye 4 times daily (morning, late morning, late afternoon, and bedtime)for two weeks postsurgery.
Other Names:
  • OMNIPRED
Placebo Comparator: Nepafenac Vehicle
One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
Drug: Prednisolone acetate ophthalmic suspension (OMNIPRED)
One drop in the study eye 4 times daily (morning, late morning, late afternoon, and bedtime)for two weeks postsurgery.
Other Names:
  • OMNIPRED
Other: Nepafenac ophthalmic suspension vehicle
1 drop TID 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
Measure Description
Time Frame
Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery
Time Frame: 3 Months
Macular edema (thickening of the center of the back of the eye) was defined as 30% or greater increase from pre-operative baseline measurement in central subfield macular thickness as measured using Optical Coherence Tomography(OCT).
3 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA).
Time Frame: From Day 7 to Day 90 (or Early Exit)
BCVA was measured using the procedure developed for the Early Treatment Diabetic Retinopathy Study.
From Day 7 to Day 90 (or Early Exit)

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

November 1, 2008

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

October 29, 2008

First Submitted That Met QC Criteria

October 29, 2008

First Posted (Estimate)

October 31, 2008

Study Record Updates

Last Update Posted (Estimate)

October 26, 2012

Last Update Submitted That Met QC Criteria

October 22, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-07-43

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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