- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00818844
Role of Nepafenac in Reducing Macular Volume After Epiretinal Membrane Surgery
July 27, 2015 updated by: Alcon Research
The purpose of this study is 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45242
- Dan Miller
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
- Other protocol-defined inclusion criteria may apply.
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 eye will receive the same study treatment as first eye.
- Other protocol-defined exclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nepafenac
Nepafenac 0.1% dosed topically TID for 3 months after Epiretinal Membrane (ERM) Surgery
|
NSAID
|
Placebo Comparator: BSS
BSS dosed topically TID for 3 months after Epiretinal Membrane (ERM) Surgery
|
BSS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Macular thickness
Time Frame: 12 weeks post operative
|
Macular thickness as measured by SD-OCT
|
12 weeks post operative
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visual Acuity
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
January 6, 2009
First Submitted That Met QC Criteria
January 7, 2009
First Posted (Estimate)
January 8, 2009
Study Record Updates
Last Update Posted (Estimate)
August 14, 2015
Last Update Submitted That Met QC Criteria
July 27, 2015
Last Verified
February 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMA-08-10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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