Steroids for Early Treatment of Radiation Retinopathy
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 4/17/2018 |
| Start Date: | July 1, 2018 |
| End Date: | September 1, 2019 |
| Contact: | Arun D Singh, MD |
| Email: | singha@ccf.org |
| Phone: | 2164459479 |
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.
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:
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
