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
|Condition or disease||Intervention/treatment||Phase|
|Radiation Retinopathy||Drug: Fluocinolone Acetonide (FA) implant||Phase 2 Phase 3|
The purpose of the project is threefold:
- 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.
- 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.
- Patients in the observational arm will be prospectively followed while comparing the multimodal therapeutic approach in a randomized trial.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|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)|
|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|
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
- Central subfield retinal thickness by OCT scan [ Time Frame: 24 months ]Anatomic outcome
- Best corrected visual acuity [ Time Frame: 24 months ]Functional outcome Best corrected Visual acuity and Visual field defect
- Need for standard of care intervention [ Time Frame: 24 months ]standard of care intervention with laser photocoagulation and/ or anti VEGF agents
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
|United States, Ohio|
|Cole Eye Instiute|
|Cleveland, Ohio, United States, 44195|