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

Sponsored by:	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

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Cataract Diabetic Eye Problems Edema Retinal Disorders

Drug Information available for: Nepafenac

U.S. FDA Resources

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

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:	September 2009 (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

Sponsors and Collaborators

Alcon Research

More Information

Responsible Party:	Principal Clinical Research Associate ( Matt Walker, PhD )
Study ID Numbers:	C-07-43
Study First Received:	October 29, 2008
Last Updated:	October 29, 2008
ClinicalTrials.gov Identifier:	NCT00782717
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alcon Research:

diabetic retinopathy; cystoid macular edema;

Study placed in the following topic categories:

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

Macular Edema
Signs and Symptoms
Diabetic Retinopathy
Cataract
Endocrinopathy
Retinal Diseases
Diabetes Complications
Retinal degeneration

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009