NCT00818844

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

August 14, 2015

Status Verified

February 1, 2012

Enrollment Period

1.4 years

First QC Date

January 6, 2009

Last Update Submit

July 27, 2015

Conditions

Epiretinal Membrane

Keywords

Nepafenacvitrectomy surgeryEpiretinal membrane surgery

Outcome Measures

Primary Outcomes (1)

  • Macular thickness

    Macular thickness as measured by SD-OCT

    12 weeks post operative

Secondary Outcomes (1)

  • Visual Acuity

    3 months

Study Arms (2)

Nepafenac

EXPERIMENTAL

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

Drug: Nepafenac 0.1%

BSS

PLACEBO COMPARATOR

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

Other: BSS

Interventions

Nepafenac 0.1%DRUG

NSAID

Nepafenac
BSSOTHER

BSS

BSS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dan Miller

Cincinnati, Ohio, 45242, United States

Location

Related Publications (1)

  • 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.

    PMID: 21724047DERIVED

MeSH Terms

Conditions

Epiretinal Membrane

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2009

First Posted

January 8, 2009

Study Start

January 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

August 14, 2015

Record last verified: 2012-02

Locations

US(1)