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Steroids for Early Treatment of Radiation Retinopathy

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ClinicalTrials.gov Identifier: NCT03238157
Recruitment Status : Suspended (Lack of funding)
First Posted : August 3, 2017
Last Update Posted : January 26, 2021
Sponsor:
Information provided by (Responsible Party):
Arun SINGH, The Cleveland Clinic

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
Radiation Retinopathy 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized 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
Estimated Study Start Date : February 1, 2021
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine


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 Name: Steroid




Primary Outcome Measures :
  1. Central subfield retinal thickness by OCT scan [ Time Frame: 24 months ]
    Anatomic outcome


Secondary Outcome Measures :
  1. Best corrected visual acuity [ Time Frame: 24 months ]
    Functional outcome Best corrected Visual acuity and Visual field defect


Other Outcome Measures:
  1. Need for standard of care intervention [ Time Frame: 24 months ]
    standard of care intervention with laser photocoagulation and/ or anti VEGF agents



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03238157


Locations
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United States, Ohio
Cole Eye Instiute
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
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Responsible Party: Arun SINGH, Professor, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03238157    
Other Study ID Numbers: NDA 201923
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: January 26, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Retinal Diseases
Eye Diseases
Fluocinolone Acetonide
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs