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Role of Nepafenac in Reducing Macular Volume After Epiretinal Membrane Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00818844
First received: January 6, 2009
Last updated: April 7, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention Phase
Epiretinal Membrane
 Drug: Nepafenac 0.1%
Other: BSS
 Phase 4

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

Resource links provided by NLM:

Drug Information available for: Nepafenac
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Macular thickness [ Time Frame: 12 weeks post operative ] [ Designated as safety issue: Yes ]
    Macular thickness as measured by SD-OCT


Secondary Outcome Measures:
  • Visual Acuity [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: January 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nepafenac
Nepafenac 0.1% dosed topically TID for 3 months after Epiretinal Membrane (ERM) Surgery
 Drug: Nepafenac 0.1%
NSAID
Placebo Comparator: BSS
BSS dosed topically TID for 3 months after Epiretinal Membrane (ERM) Surgery
 Other: BSS
BSS

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

    • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00818844

Locations
United States, Ohio
Dan Miller
Cincinnati, Ohio, United States, 45242
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided by Alcon Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00818844     History of Changes
Other Study ID Numbers: SMA-08-10
Study First Received: January 6, 2009
Last Updated: April 7, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alcon Research:
Nepafenac
vitrectomy surgery
Epiretinal membrane surgery

Additional relevant MeSH terms:
Epiretinal Membrane
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013