Role of Nepafenac in Reducing Macular Volume After Epiretinal Membrane Surgery

NCT ID: NCT00818844

Last Updated: 2015-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-06-30

Brief 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.

Conditions

Epiretinal Membrane

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Nepafenac

Nepafenac 0.1% dosed topically TID for 3 months after Epiretinal Membrane (ERM) Surgery

Group Type: EXPERIMENTAL

Nepafenac 0.1%

Intervention Type: DRUG

NSAID

BSS

BSS dosed topically TID for 3 months after Epiretinal Membrane (ERM) Surgery

Group Type: PLACEBO_COMPARATOR

BSS

Intervention Type: OTHER

BSS

Interventions

Nepafenac 0.1%

NSAID

Intervention Type: DRUG

BSS

BSS

Intervention Type: OTHER

Eligibility 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 eye will receive the same study treatment as first eye.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dan Miller

Cincinnati, Ohio, United States

Countries

United States

References

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. doi: 10.1016/j.ophtha.2011.01.034. No abstract available.

Reference Type: DERIVED

PMID: 21724047 (View on PubMed)

Other Identifiers

SMA-08-10

Identifier Type: -

Identifier Source: org_study_id