Steroids for Early Treatment of Radiation Retinopathy

Radiation Retinopathy Clinical Trial

Official title:

Steroids for Early Treatment of Radiation Retinopathy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03238157
• Other study ID #: NDA 201923
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: February 1, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: August 2021
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Radiation Retinopathy
• Retinal Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Cole Eye Instiute	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Need for standard of care intervention	standard of care intervention with laser photocoagulation and/ or anti VEGF agents	24 months
Primary	Central subfield retinal thickness by OCT scan	Anatomic outcome	24 months
Secondary	Best corrected visual acuity	Functional outcome Best corrected Visual acuity and Visual field defect	24 months