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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.
The purpose of the project is threefold:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation | No 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. 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). | |
| Intervention | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluocinolone Acetonide (FA) implant | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Central subfield retinal thickness by OCT scan | Anatomic outcome | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Best corrected visual acuity | Functional outcome Best corrected Visual acuity and Visual field defect | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Need for standard of care intervention | standard of care intervention with laser photocoagulation and/ or anti VEGF agents | 24 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cole Eye Instiute | Cleveland | Ohio | 44195 | United States |
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| ID | Term |
|---|---|
| D005446 | Fluocinolone Acetonide |
| D013256 | Steroids |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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Randomized to either observation (2:1) (standard of care) or intravitreal Fluocinolone Acetonide (FA) implant
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|
| D013259 |
| Steroids, Fluorinated |