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Role of Nepafenac in Reducing Macular Volume After Epiretinal Membrane Surgery

Primary Purpose

Epiretinal Membrane

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nepafenac 0.1%
BSS
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Epiretinal Membrane focused on measuring Nepafenac, vitrectomy surgery, Epiretinal membrane surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dan Miller

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nepafenac

BSS

Arm Description

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

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

Outcomes

Primary Outcome Measures

Macular thickness
Macular thickness as measured by SD-OCT

Secondary Outcome Measures

Visual Acuity

Full Information

First Posted
January 6, 2009
Last Updated
July 27, 2015
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00818844
Brief Title
Role of Nepafenac in Reducing Macular Volume After Epiretinal Membrane Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiretinal Membrane
Keywords
Nepafenac, vitrectomy surgery, Epiretinal membrane surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nepafenac
Arm Type
Experimental
Arm Description
Nepafenac 0.1% dosed topically TID for 3 months after Epiretinal Membrane (ERM) Surgery
Arm Title
BSS
Arm Type
Placebo Comparator
Arm Description
BSS dosed topically TID for 3 months after Epiretinal Membrane (ERM) Surgery
Intervention Type
Drug
Intervention Name(s)
Nepafenac 0.1%
Intervention Description
NSAID
Intervention Type
Other
Intervention Name(s)
BSS
Intervention Description
BSS
Primary Outcome Measure Information:
Title
Macular thickness
Description
Macular thickness as measured by SD-OCT
Time Frame
12 weeks post operative
Secondary Outcome Measure Information:
Title
Visual Acuity
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. 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.
Facility Information:
Facility Name
Dan Miller
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21724047
Citation
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.
Results Reference
derived

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Role of Nepafenac in Reducing Macular Volume After Epiretinal Membrane Surgery

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