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OpenTrials
Completed

NCT Number: NCT00818844

Role of Nepafenac in Reducing Macular Volume After Epiretinal Membrane Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dan Miller

Cincinnati, Ohio, 45242, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nepafenac 0.1%

Drug

NSAID

BSS

Other

BSS

Primary outcomes

  1. Macular thickness

    Time frame: 12 weeks post operative

    Macular thickness as measured by SD-OCT

Secondary outcomes

  1. Visual Acuity

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 8, 2009
Registry last updated
Aug 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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