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

This study is currently recruiting participants.

Verified by Alcon Research, September 2009

First Received: October 29, 2008 Last Updated: September 22, 2009 History of Changes

Sponsor:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00782717

Purpose

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.

Condition	Intervention	Phase
Macular Edema	Drug: nepafenac Drug: Nepafenac vehicle	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Cataract Diabetic Eye Problems Edema Retinal Disorders Surgery

Drug Information available for: Nepafenac

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

percentage of patients who develop macular edema (defined as 30% or greater increase from preoperative baseline in central subfield macular thickness) within 90 days following cataract surgery [ Time Frame: preoperative baseline and postoperative days 7, 14, 30, 60, 90 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

percentage of patients with best-corrected visual acuity (BCVA) decrease of >5 ETDR letters from the Day 7 postoperative visit [ Time Frame: preoperative baseline and postoperative days 7, 14, 30, 60, 90 ] [ Designated as safety issue: No ]

Estimated Enrollment:	260
Study Start Date:	October 2008
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental NEVANAC	Drug: nepafenac 1 drop TID beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery
2: Placebo Comparator Nepafenac vehicle	Drug: Nepafenac vehicle 1 drop TID beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

patients with non-proliferative diabetic retinopathy (mild, moderate or severe) and planned cataract extraction by phacoemulsification

Exclusion Criteria:

central subfiled macular thickness greater than or equal to 250 microns; CME in either eye

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782717

Contacts

Contact: Alcon Call Center

1-888-451-3937

Locations

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

Sponsors and Collaborators

Alcon Research

More Information

No publications provided

Responsible Party:	Alcon Research, Ltd. ( Dana Sager, Associate Director )
Study ID Numbers:	C-07-43
Study First Received:	October 29, 2008
Last Updated:	September 22, 2009
ClinicalTrials.gov Identifier:	NCT00782717 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alcon Research:

diabetic retinopathy; cystoid macular edema;

Additional relevant MeSH terms:

Eye Diseases
Vascular Diseases
Diabetes Mellitus
Retinal Degeneration
Edema
Endocrine System Diseases
Macular Degeneration

Diabetic Angiopathies
Macular Edema
Signs and Symptoms
Diabetic Retinopathy
Cardiovascular Diseases
Retinal Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on February 08, 2010