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Nepafenac Once Daily for Macular Edema - Study 1

Primary Purpose

Non-Proliferative Diabetic Retinopathy, Cataract

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Nepafenac Ophthalmic Suspension, 0.3%
Nepafenac vehicle
Prednisolone acetate
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Proliferative Diabetic Retinopathy focused on measuring Diabetes Type I, Diabetes Type II, non-proliferative diabetic retinopathy, macular edema, Cataract

Eligibility Criteria

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

Inclusion Criteria:

  • Planned cataract extraction by phacoemulsification with implantation of a posterior chamber intraocular lens;
  • History of Type 1 or 2 diabetes and non-proliferative diabetic retinopathy (NPDR) (mild, moderate, or severe) in the study eye;
  • Best corrected visual acuity (BCVA) of 73 letters or worse in the study eye with expectation of improvement after surgery;
  • Understand and sign an informed consent document;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Pre-existing macular edema in the study eye;
  • History in the study eye of retinal detachment, wet age-related macular degeneration, chronic or recurrent inflammatory eye disease, or prior procedures;
  • Planned cataract surgery in the fellow eye after randomization and prior to the Day 90 postoperative study visit or through study exit;
  • Planned multiple procedures for the study eye during the cataract/intraocular lens implantation surgery;
  • Use of exclusionary medications, including nonsteroidal anti-inflammatory drugs (NSAIDs) and steroids, as specified in protocol.
  • Participation in any other clinical study within 30 days of the screening visit;
  • Females of childbearing potential who are breast feeding, have a positive urine pregnancy test at screening, are not willing to undergo a urine pregnancy test upon entering or exiting the study, intend to become pregnant during the study, or do not agree to use adequate birth control methods for the duration of the study;
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Nepafenac

    Vehicle

    Arm Description

    With prednisolone acetate standard of care, Nepafenac Ophthalmic Suspension, 0.3%, 1 drop instilled in the operative eye 1 day prior to surgery, continuing on the day of surgery, and for 90 days following surgery. An additional 1 drop will be administered 30 to 120 minutes prior to surgery.

    With prednisolone acetate standard of care, Nepafenac vehicle, 1 drop instilled in the operative eye 1 day prior to surgery, continuing on the day of surgery, and for 90 days following surgery. An additional 1 drop will be administered 30 to 120 minutes prior to surgery.

    Outcomes

    Primary Outcome Measures

    Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90
    BCVA (with spectacles or other visual corrective devices) was reported in letters read correctly, using the Early Treatment Diabetic Retinopathy Study (ETDRS) test of 70 letters. Improvement of BCVA was defined as an increase (gain) in the number of letters read, compared to the baseline assessment. One eye (study eye) contributed to the analysis.
    Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)
    Macular edema was defined as ≥ 30% Increase from pre-operative baseline in central subfield macular thickness, as measured with Spectral Domain Ocular Coherence Tomography (SD-OCT). One eye (study eye) contributed to the analysis.

    Secondary Outcome Measures

    Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90
    Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60
    Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit [Time Frame: Day 7 up to Any Visit]
    Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit

    Full Information

    First Posted
    May 10, 2013
    Last Updated
    June 23, 2016
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01853072
    Brief Title
    Nepafenac Once Daily for Macular Edema - Study 1
    Official Title
    Randomized, Double-Masked, Vehicle Controlled, Clinical Evaluation To Assess The Safety And Efficacy Of Nepafenac Ophthalmic Suspension, 0.3% For Improvement In Clinical Outcomes Among Diabetic Subjects Following Cataract Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2013 (undefined)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    May 2015 (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 demonstrate superiority of Nepafenac Ophthalmic Suspension, 0.3% dosed once daily relative to Nepafenac Vehicle based upon clinical outcomes among diabetic subjects following cataract surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-Proliferative Diabetic Retinopathy, Cataract
    Keywords
    Diabetes Type I, Diabetes Type II, non-proliferative diabetic retinopathy, macular edema, Cataract

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    881 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Nepafenac
    Arm Type
    Experimental
    Arm Description
    With prednisolone acetate standard of care, Nepafenac Ophthalmic Suspension, 0.3%, 1 drop instilled in the operative eye 1 day prior to surgery, continuing on the day of surgery, and for 90 days following surgery. An additional 1 drop will be administered 30 to 120 minutes prior to surgery.
    Arm Title
    Vehicle
    Arm Type
    Placebo Comparator
    Arm Description
    With prednisolone acetate standard of care, Nepafenac vehicle, 1 drop instilled in the operative eye 1 day prior to surgery, continuing on the day of surgery, and for 90 days following surgery. An additional 1 drop will be administered 30 to 120 minutes prior to surgery.
    Intervention Type
    Drug
    Intervention Name(s)
    Nepafenac Ophthalmic Suspension, 0.3%
    Other Intervention Name(s)
    Nepafenac
    Intervention Description
    Test intervention
    Intervention Type
    Other
    Intervention Name(s)
    Nepafenac vehicle
    Intervention Description
    Inactive ingredients used as placebo comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Prednisolone acetate
    Other Intervention Name(s)
    Omnipred™, Prednisolone acetate ophthalmic suspension
    Intervention Description
    1 drop instilled in the operative eye 4 times daily beginning post-operatively on the day of surgery for the first 2 weeks, followed by 2 times daily for the next 2 weeks
    Primary Outcome Measure Information:
    Title
    Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90
    Description
    BCVA (with spectacles or other visual corrective devices) was reported in letters read correctly, using the Early Treatment Diabetic Retinopathy Study (ETDRS) test of 70 letters. Improvement of BCVA was defined as an increase (gain) in the number of letters read, compared to the baseline assessment. One eye (study eye) contributed to the analysis.
    Time Frame
    Baseline to Day 14, and maintained through Day 90
    Title
    Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)
    Description
    Macular edema was defined as ≥ 30% Increase from pre-operative baseline in central subfield macular thickness, as measured with Spectral Domain Ocular Coherence Tomography (SD-OCT). One eye (study eye) contributed to the analysis.
    Time Frame
    Day 0 to Day 90
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90
    Time Frame
    Baseline to Day 90
    Title
    Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60
    Time Frame
    Baseline to Day 60
    Title
    Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit [Time Frame: Day 7 up to Any Visit]
    Time Frame
    Day 7 up to any visit through Day 90
    Title
    Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit
    Time Frame
    Day 7 up to any visit through Day 90

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Planned cataract extraction by phacoemulsification with implantation of a posterior chamber intraocular lens; History of Type 1 or 2 diabetes and non-proliferative diabetic retinopathy (NPDR) (mild, moderate, or severe) in the study eye; Best corrected visual acuity (BCVA) of 73 letters or worse in the study eye with expectation of improvement after surgery; Understand and sign an informed consent document; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Pre-existing macular edema in the study eye; History in the study eye of retinal detachment, wet age-related macular degeneration, chronic or recurrent inflammatory eye disease, or prior procedures; Planned cataract surgery in the fellow eye after randomization and prior to the Day 90 postoperative study visit or through study exit; Planned multiple procedures for the study eye during the cataract/intraocular lens implantation surgery; Use of exclusionary medications, including nonsteroidal anti-inflammatory drugs (NSAIDs) and steroids, as specified in protocol. Participation in any other clinical study within 30 days of the screening visit; Females of childbearing potential who are breast feeding, have a positive urine pregnancy test at screening, are not willing to undergo a urine pregnancy test upon entering or exiting the study, intend to become pregnant during the study, or do not agree to use adequate birth control methods for the duration of the study; Other protocol-defined exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Clinical Project Lead GCRA, Pharma
    Organizational Affiliation
    Alcon Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Nepafenac Once Daily for Macular Edema - Study 1

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