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Role of Nepafenac in Reducing Macular Volume After Epiretinal Membrane Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00818844
Recruitment Status : Completed
First Posted : January 8, 2009
Last Update Posted : August 14, 2015
Information provided by (Responsible Party):
Alcon Research

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.

Condition or disease Intervention/treatment Phase
Epiretinal Membrane Drug: Nepafenac 0.1% Other: BSS Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Study Start Date : January 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Nepafenac

Arm Intervention/treatment
Experimental: Nepafenac
Nepafenac 0.1% dosed topically TID for 3 months after Epiretinal Membrane (ERM) Surgery
Drug: Nepafenac 0.1%

Placebo Comparator: BSS
BSS dosed topically TID for 3 months after Epiretinal Membrane (ERM) Surgery
Other: BSS

Primary Outcome Measures :
  1. Macular thickness [ Time Frame: 12 weeks post operative ]
    Macular thickness as measured by SD-OCT

Secondary Outcome Measures :
  1. Visual Acuity [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00818844

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United States, Ohio
Dan Miller
Cincinnati, Ohio, United States, 45242
Sponsors and Collaborators
Alcon Research
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Alcon Research Identifier: NCT00818844    
Other Study ID Numbers: SMA-08-10
First Posted: January 8, 2009    Key Record Dates
Last Update Posted: August 14, 2015
Last Verified: February 2012
Keywords provided by Alcon Research:
vitrectomy surgery
Epiretinal membrane surgery
Additional relevant MeSH terms:
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Epiretinal Membrane
Retinal Diseases
Eye Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents