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Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy (AL)

Primary Purpose

Radiation Retinopathy, Visual Impairment

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Faricimab
fluocinolone acetonide
Sponsored by
Jaeb Center for Health Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Radiation Retinopathy focused on measuring Visual Acuity, Radiation retinopathy, Faricima, Fluocinolone Acetonide

Eligibility Criteria

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

Key Inclusion Criteria Primary uveal melanoma (excluding iris melanoma) receiving primary treatment with plaque brachytherapy Absence of unrelated cause of visual loss Baseline visual acuity ≥ 34 letters (20/200 Snellen equivalent or better) Posterior tumor margin >0 mm from the center of the macula (i.e., tumor is NOT under the geometric center of the fovea) Posterior tumor margin >0 mm from the closest disc margin (i.e., tumor is not touching the edge of the optic disc) Calculated total dose to center of the macula ≥30 Gy Key Exclusion Criteria Opaque media Inability to undergo fluorescein angiography Less than 18 years of age Prior vitrectomy Intraocular pressure (IOP) ≥ 25 mmHg or history of steroid- induced IOP elevation that required treatment at baseline IOP ≥ 25 mmHg at randomization or increase in IOP ≥ 8 mmHg from baseline to randomization (following steroid challenge

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    No Intervention

    Arm Label

    Intravitreal faricimab

    Fluocinolone Acetonide Intravitreal Implants

    Observation

    Arm Description

    Study eyes assigned to receive faricimab will receive a dose of 6.0 mg of faricimab. Faricimab is supplied in a single use vial.

    Study eyes assigned to receive fluocinolone acetonide intravitreal implant will receive a dose of 0.19 mg fluocinolone acetonide intravitreal implant (Iluvien). The implant is supplied in a sterile single use applicator with a 25-gauge needle

    Outcomes

    Primary Outcome Measures

    Change in visual acuity from baseline
    Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.
    Loss of 15 or more letters of visual acuity from baseline
    Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 25, 2023
    Last Updated
    September 26, 2023
    Sponsor
    Jaeb Center for Health Research
    Collaborators
    National Eye Institute (NEI), National Institutes of Health (NIH), Alimera Sciences, Genentech, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05844982
    Brief Title
    Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy
    Acronym
    AL
    Official Title
    A Trial Evaluating Intravitreal Faricimab (6.0 mg) Injections or Fluocinolone Acetonide (0.19 mg Intravitreal Implants vs Observation for Prevention of Visual Acuity Loss Due to Radiation Retinopathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 26, 2023 (Anticipated)
    Primary Completion Date
    October 26, 2026 (Anticipated)
    Study Completion Date
    October 26, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Jaeb Center for Health Research
    Collaborators
    National Eye Institute (NEI), National Institutes of Health (NIH), Alimera Sciences, Genentech, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This randomized controlled trial will evaluate the effect of intravitreal faricimab or fluocinolone acetonide (FAc) intravitreal implant compared with observation on long-term visual acuity following treatment of choroidal melanoma with iodine-125 plaque brachytherapy.
    Detailed Description
    The primary objectives are to compare long-term visual acuity outcomes in eyes that receive repeated treatment with faricimab or fluocinolone acetonide intravitreal implants with those observed initially and treated only if macular edema (ME) develops. The secondary objectives are to determine if repeated treatment with faricimab or fluocinolone acetonide intravitreal implants versus observation can prevent or alter the course of ME from radiation retinopathy and to evaluate the natural history of radiation retinopathy with multimodal imaging including widefield color photographs, widefield fluorescein angiography and OCTA.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Radiation Retinopathy, Visual Impairment
    Keywords
    Visual Acuity, Radiation retinopathy, Faricima, Fluocinolone Acetonide

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    600 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intravitreal faricimab
    Arm Type
    Active Comparator
    Arm Description
    Study eyes assigned to receive faricimab will receive a dose of 6.0 mg of faricimab. Faricimab is supplied in a single use vial.
    Arm Title
    Fluocinolone Acetonide Intravitreal Implants
    Arm Type
    Active Comparator
    Arm Description
    Study eyes assigned to receive fluocinolone acetonide intravitreal implant will receive a dose of 0.19 mg fluocinolone acetonide intravitreal implant (Iluvien). The implant is supplied in a sterile single use applicator with a 25-gauge needle
    Arm Title
    Observation
    Arm Type
    No Intervention
    Intervention Type
    Drug
    Intervention Name(s)
    Faricimab
    Intervention Description
    6.0 mg intravitreal injection at randomization and every 3 months
    Intervention Type
    Drug
    Intervention Name(s)
    fluocinolone acetonide
    Intervention Description
    0.19 mg fluocinolone acetonide intravitreal implant (Iluvien) at randomization and at 24 months
    Primary Outcome Measure Information:
    Title
    Change in visual acuity from baseline
    Description
    Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.
    Time Frame
    from baseline at 3 years
    Title
    Loss of 15 or more letters of visual acuity from baseline
    Description
    Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.
    Time Frame
    from baseline at 3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Key Inclusion Criteria Primary uveal melanoma (excluding iris melanoma) receiving primary treatment with plaque brachytherapy Absence of unrelated cause of visual loss Baseline visual acuity ≥ 34 letters (20/200 Snellen equivalent or better) Posterior tumor margin >0 mm from the center of the macula (i.e., tumor is NOT under the geometric center of the fovea) Posterior tumor margin >0 mm from the closest disc margin (i.e., tumor is not touching the edge of the optic disc) Calculated total dose to center of the macula ≥30 Gy Key Exclusion Criteria Opaque media Inability to undergo fluorescein angiography Less than 18 years of age Prior vitrectomy Intraocular pressure (IOP) ≥ 25 mmHg or history of steroid- induced IOP elevation that required treatment at baseline IOP ≥ 25 mmHg at randomization or increase in IOP ≥ 8 mmHg from baseline to randomization (following steroid challenge
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cynthia Stockdale, MPH
    Phone
    8139758690
    Email
    DRCRNET@JAEB.ORG

    12. IPD Sharing Statement

    Learn more about this trial

    Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy

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