Macular Edema Incidence/Severity Reduction With Nevanac - Full Text View

Sponsor:	Alcon Research
Information provided by (Responsible Party):	Alcon Research
ClinicalTrials.gov Identifier:	NCT00939276

Purpose

The purpose of this study is to determine the safety and efficacy of Nevanac for the prevention of macular edema in patients with diabetic retinopathy within 90 days following cataract surgery.

Condition	Intervention	Phase
Diabetic Retinopathy	Drug: nepafenac (Nevanac) Drug: nepafenac (Nevanac) vehicle	Phase III

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:

percentage of patients who develop macular edema 90 days following surgery [ Time Frame: preoperative screening and postoperative days 7, 14, 30, 60, 90 ] [ Designated as safety issue: Yes ]

Enrollment:	166
Study Start Date:	July 2009
Study Completion Date:	August 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 nepafenac (Nevanac)	Drug: nepafenac (Nevanac) 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 (Nevanac) 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:	No

Criteria

Inclusion Criteria:

NPDR (mild, moderate or severe) in the study eye as defined by the International Clinical Diabetic Retinopathy Disease Severity Scale
Central subfield macular thickness < or = 320 micron in the study eye prior to cataract surgery as determined by SD-OCT and confirmed by the reading center
Absence of CME or cystoid abnormalities in the study eye as detected by SD-OCT and confirmed by the reading center

Exclusion Criteria:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00939276

Locations

United States, Texas
Contact 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:	NCT00939276 History of Changes
Other Study ID Numbers:	C-09-003, EudraCT Number: 2009-010536-17
Study First Received:	July 10, 2009
Last Updated:	November 10, 2011
Health Authority:	United States: Food and Drug Administration; France: Afssaps - French Health Products Safety Agency

Keywords provided by Alcon Research:

cataract surgery
macular edema
prevention

Additional relevant MeSH terms:

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

Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Macular Degeneration
Retinal Degeneration

ClinicalTrials.gov processed this record on February 09, 2012