Steroids for Early Treatment of Radiation Retinopathy

NeuroTherapia, Inc.

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Radiation Retinopathy

Treatments: Drug: Fluocinolone Acetonide (FA) implant

Study type: Interventional

Funder types: Other

Identifiers

NCT03238157

NDA 201923

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Observation

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Drug: Fluocinolone Acetonide (FA) implant