Role of Nepafenac in Reducing Macular Volume After Epiretinal Membrane Surgery

Epiretinal Membrane Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00818844
• Other study ID #: SMA-08-10
• Status: Completed
• Phase: Phase 4
• First received: January 6, 2009
• Last updated: July 27, 2015
• Start date: January 2009
• Est. completion date: June 2010

Study information

• Verified date: February 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Epiretinal Membrane

Intervention

Drug:
• Nepafenac 0.1%
NSAID

Other:
• BSS
BSS

Locations

Country	Name	City	State
United States	Dan Miller	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Macular thickness	Macular thickness as measured by SD-OCT	12 weeks post operative	Yes
Secondary	Visual Acuity		3 months	Yes