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

Sponsor:	Alcon Research
Information provided by (Responsible Party):	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:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Cataract Diabetic Eye Problems Edema Retinal Disorders

Drug Information available for: Nepafenac

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

The Percentage of Diabetic Retinopathy Patients Who Develop Macular Edema (ME) Within 90 Days Following Cataract Surgery [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
Development of macular edema (thickening of the center of the back of the eye) was defined as 30% or greater increase from pre-operative Baseline in central subfield macular thickness as measured using Optical Coherence Tomography(OCT).

Secondary Outcome Measures:

The Percentage of Patients Who Had a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA). [ Time Frame: From day 7 to day 90 (or Early Exit) ] [ Designated as safety issue: No ]
BCVA was measured using the procedure developed for the Early Treatment Diabetic Retinopathy Study.

Enrollment:	263
Study Start Date:	October 2008
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 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
Placebo Comparator: 2 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

Locations

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

Sponsors and Collaborators

Alcon Research

More Information

No publications provided

Responsible Party:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00782717 History of Changes
Other Study ID Numbers:	C-07-43
Study First Received:	October 29, 2008
Results First Received:	August 17, 2011
Last Updated:	November 28, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alcon Research:

diabetic retinopathy; cystoid macular edema;

Additional relevant MeSH terms:

Diabetic Retinopathy
Edema
Macular Edema
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases

Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Macular Degeneration
Retinal Degeneration

ClinicalTrials.gov processed this record on February 09, 2012