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Steroids for Early Treatment of Radiation Retinopathy

Sponsor
The Cleveland Clinic (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03238157
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
7
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Radiation retinopathy is a known complication of ocular radiation therapy. To date there is no known effective treatment. In addition to their anti-vascular endothelial growth factor (VEGF) properties, corticosteroids decrease the retinal capillary permeability by increasing the activity/density of tight junctions and acute inflammatory effects of radiation in various tissues.

Condition or Disease Intervention/Treatment Phase
  • Drug: Fluocinolone Acetonide (FA) implant
 Phase 2/Phase 3

Detailed Description

The purpose of the project is threefold:

  1. To study the natural history of radiation retinopathy using advanced imaging techniques. A combination of macular OCT to evaluate for edema, OCT angiography to evaluate for macular and peri-papillary ischemia and wide-field angiography for peripheral ischemia and leakage. Potential role of OCT angiography in radiation retinopathy will be evaluated by comparison to other eye (control) and FA.

  2. Currently there is no consensus on effective management strategy for radiation retinopathy. Patients in the interventional will be prospectively followed to study efficacy of steroids for early treatment of radiation retinopathy while comparing the multimodal therapeutic approach in a randomized trial.

  3. Patients in the observational arm will be prospectively followed while comparing the multimodal therapeutic approach in a randomized trial.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized to either observation (2:1) (standard of care) or intravitreal Fluocinolone Acetonide (FA) implantRandomized to either observation (2:1) (standard of care) or intravitreal Fluocinolone Acetonide (FA) implant
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Steroids for Early Treatment of Radiation Retinopathy
Anticipated Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Observation

The study will only include those patients that are ascertained be at more than 50% risk for vision loss (20/200 or worse at 3 years) because of total radiation dose of >40 Gy to the center of the macula. These "at risk" patients included in the study will receive intravitreal triamcinolone (4 mg in 0.1 ml) injected at the time of plaque removal. If lack of IOP rise (30 mm Hg or more) at 3 months, then randomized to either observation (2:1) (standard of care).
Active Comparator: Intervention

The study will only include those patients that are ascertained be at more than 50% risk for vision loss (20/200 or worse at 3 years) because of total radiation dose of >40 Gy to the center of the macula.1 These "at risk" patients included in the study will receive intravitreal triamcinolone (4 mg in 0.1 ml) injected at the time of plaque removal. If lack of IOP rise (30 mm Hg or more) at 3 months, then randomized to intravitreal Fluocinolone Acetonide (FA) implant.

Drug: Fluocinolone Acetonide (FA) implant
Fluocinolone Acetonide (FA) implant is designed to release FA at an initial rate of approximately 0.6 g/d, decreasing over the first month to a steady rate of 0.3 to 0.4 g/d with a duration of approximately 30 months.
Other Names:
  • Steroid

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Central subfield retinal thickness by OCT scan [24 months]

      Anatomic outcome

    Secondary Outcome Measures

    1. Best corrected visual acuity [24 months]

      Functional outcome Best corrected Visual acuity and Visual field defect

    Other Outcome Measures

    1. Need for standard of care intervention [24 months]

      standard of care intervention with laser photocoagulation and/ or anti VEGF agents

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Primary uveal melanoma

    • Primary treatment with plaque brachytherapy

    • Baseline visual acuity 20/200 or better

    • Posterior tumor margin >1.50 mm from the center of the macula

    • Posterior tumor margin > 1.50 mm from the closest disc margin

    • Calculated total dose to center of the macula >40 Gy

    Exclusion Criteria:

    • Iris melanoma

    • Opaque media

    • less than 21 years of age

    • Inability to give consent

    • Positive pregnancy test

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cole Eye Instiute Cleveland Ohio United States 44195

    Sponsors and Collaborators

    • The Cleveland Clinic

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Arun SINGH, Professor, The Cleveland Clinic
    ClinicalTrials.gov Identifier:
    NCT03238157
    Other Study ID Numbers:
    • NDA 201923
    First Posted:
    Aug 3, 2017
    Last Update Posted:
    Aug 4, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Retinal Diseases
    Fluocinolone Acetonide

    Study Results

    No Results Posted as of Aug 4, 2021