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A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle After Cataract Surgery in Diabetic Retinopathy Patients

Primary Purpose

Macular Edema

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Nepafenac ophthalmic suspension, 0.1% (NEVANAC)
Nepafenac ophthalmic suspension vehicle
Prednisolone acetate ophthalmic suspension (OMNIPRED)
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Macular Edema focused on measuring diabetic retinopathy, cystoid macular edema;

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with non-proliferative diabetic retinopathy (mild, moderate or severe) and planned cataract extraction by phacoemulsification.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Central subfiled macular thickness greater than or equal to 250 microns
  • CME in either eye.
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    NEVANAC

    Nepafenac Vehicle

    Arm Description

    One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.

    One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.

    Outcomes

    Primary Outcome Measures

    Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery
    Macular edema (thickening of the center of the back of the eye) was defined as 30% or greater increase from pre-operative baseline measurement in central subfield macular thickness as measured using Optical Coherence Tomography(OCT).

    Secondary Outcome Measures

    Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA).
    BCVA was measured using the procedure developed for the Early Treatment Diabetic Retinopathy Study.

    Full Information

    First Posted
    October 29, 2008
    Last Updated
    October 22, 2012
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00782717
    Brief Title
    A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle After Cataract Surgery in Diabetic Retinopathy Patients
    Official Title
    A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle Following Cataract Surgery in Diabetic Retinopathy Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2008 (undefined)
    Primary Completion Date
    July 2010 (Actual)
    Study Completion Date
    July 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 determine whether nepafenac is safe and effective for reducing the incidence of macular edema following cataract surgery in diabetic retinopathy patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Macular Edema
    Keywords
    diabetic retinopathy, cystoid macular edema;

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    263 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    NEVANAC
    Arm Type
    Experimental
    Arm Description
    One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
    Arm Title
    Nepafenac Vehicle
    Arm Type
    Placebo Comparator
    Arm Description
    One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
    Intervention Type
    Drug
    Intervention Name(s)
    Nepafenac ophthalmic suspension, 0.1% (NEVANAC)
    Other Intervention Name(s)
    NEVANAC
    Intervention Description
    1 drop TID beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery.
    Intervention Type
    Other
    Intervention Name(s)
    Nepafenac ophthalmic suspension vehicle
    Intervention Description
    1 drop TID beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery
    Intervention Type
    Drug
    Intervention Name(s)
    Prednisolone acetate ophthalmic suspension (OMNIPRED)
    Other Intervention Name(s)
    OMNIPRED
    Intervention Description
    One drop in the study eye 4 times daily (morning, late morning, late afternoon, and bedtime)for two weeks postsurgery.
    Primary Outcome Measure Information:
    Title
    Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery
    Description
    Macular edema (thickening of the center of the back of the eye) was defined as 30% or greater increase from pre-operative baseline measurement in central subfield macular thickness as measured using Optical Coherence Tomography(OCT).
    Time Frame
    3 Months
    Secondary Outcome Measure Information:
    Title
    Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA).
    Description
    BCVA was measured using the procedure developed for the Early Treatment Diabetic Retinopathy Study.
    Time Frame
    From Day 7 to Day 90 (or Early Exit)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with non-proliferative diabetic retinopathy (mild, moderate or severe) and planned cataract extraction by phacoemulsification. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Central subfiled macular thickness greater than or equal to 250 microns CME in either eye. Other protocol-defined exclusion criteria may apply.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22927737
    Citation
    Singh R, Alpern L, Jaffe GJ, Lehmann RP, Lim J, Reiser HJ, Sall K, Walters T, Sager D. Evaluation of nepafenac in prevention of macular edema following cataract surgery in patients with diabetic retinopathy. Clin Ophthalmol. 2012;6:1259-69. doi: 10.2147/OPTH.S31902. Epub 2012 Aug 3.
    Results Reference
    result
    PubMed Identifier
    27388251
    Citation
    Pollack A, Staurenghi G, Sager D, Mukesh B, Reiser H, Singh RP. Prospective randomised clinical trial to evaluate the safety and efficacy of nepafenac 0.1% treatment for the prevention of macular oedema associated with cataract surgery in patients with diabetic retinopathy. Br J Ophthalmol. 2017 Apr;101(4):423-427. doi: 10.1136/bjophthalmol-2016-308617. Epub 2016 Jul 7.
    Results Reference
    derived

    Learn more about this trial

    A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle After Cataract Surgery in Diabetic Retinopathy Patients

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