Role of Nepafenac in Reducing Macular Volume After Epiretinal Membrane Surgery

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2010 by Alcon Research. Recruitment status was Recruiting

First Received on January 6, 2009. Last Updated on January 27, 2010 History of Changes

Sponsor:	Alcon Research
Collaborator:	University of Cincinnati
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00818844

Purpose

To compare the macular volume of patients treated with a 3-month course of topical Nepafenac (0.1% solution) to patients treated with a placebo course following epiretinal membrane surgery.

Condition	Intervention
Epiretinal Membrane	Drug: Nepafenac Drug: BSS

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention

Resource links provided by NLM:

Drug Information available for: Nepafenac

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Effect of Nepafenac on macular volume after epiretinal surgery as measured by OCT analysis [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Visual Acuity [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	January 2008
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Nepafenac 0.1% TID - 3 months	Drug: Nepafenac NSAID
Placebo Comparator: 2 BSS - TID - 3 months	Drug: BSS BSS

Eligibility

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

Criteria

Inclusion Criteria:

18 year of age or older, of any race and either sex.
Able to understand and sign an informed consent that has been approved by an Institutional Review Board.
Must agree to comply with study visit schedule and other study requirements.
Must have vision loss associated with idiopathic epiretinal membrane and secondary retinal edema.
Must have pre-operative central foveal thickness greater than 300 microns.
Prior cataract surgery must be at least 6 months postoperative.

Exclusion Criteria:

Vision loss associated with maculopathies other than idiopathic epiretinal membrane and secondary retinal edema (e.g. branch retinal vein occlusion, central retinal vein occlusion, wet macular degeneration, diabetic retinopathy, posterior uveitis).
Dry macular degeneration (drusen) with central geographic atrophy.
Concomitant cataract surgery performed at the time of study vitrectomy.
Prior vitrectomy surgery in the study eye(s).
Prior macula laser treatment in the study eye(s).
Prior periocular steroid injections in the study eye(s) within preceding 6 months.
Prior cataract surgery in the study eye(s) within the last 6 months.
Any systemic or ocular disease or disorder, complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
Use of topical ocular medications during the study period.
Antibiotics (systemic or topical) outside of study protocol may not be used within 7 days of preoperative/baseline visit or anytime after this visit for the duration of the study.
Women of childbearing potential not using reliable means of birth control.
Women who are pregnant or lactating.
Enrollment of more than one person per household at the same time.
Enrollment of the investigator or his or her staff, family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals.
Participation in any investigational drug or device study within 30 days of entering this study. Note: Patients may have both eyes enrolled in this study provided that 2nd eye enrollment takes place 30 days after completion of the first eye. Second eyes will receive the same study treatment as first eyes.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00818844

Contacts

Contact: Dan Miller

513-984-5133

Locations

United States, Ohio
Dan Miller	Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Dan Miller 513-984-5133

Sponsors and Collaborators

Alcon Research

University of Cincinnati

More Information

No publications provided by Alcon Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Schoenberger SD, Miller DM, Petersen MR, Foster RE, Riemann CD, Sisk RA. Nepafenac for epiretinal membrane surgery. Ophthalmology. 2011 Jul;118(7):1482.e1-3. No abstract available.

Responsible Party:	Dan Miller, MD, Phd, Voluntary Assistant Clinical Professor, Dept of Ophthalmology, Univ. of Cincinnati College of Medicine, Cincinnati Eye Institute
ClinicalTrials.gov Identifier:	NCT00818844 History of Changes
Other Study ID Numbers:	SMA-08-10
Study First Received:	January 6, 2009
Last Updated:	January 27, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alcon Research:

Nepafenac
vitrectomy surgery
Epiretinal membrane surgery

Additional relevant MeSH terms:

Epiretinal Membrane
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on February 09, 2012