Steroids for Early Treatment of Radiation Retinopathy

NCT03238157 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: NDA 201923
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Radiation Retinopathy

Outcome Measures

Primary Outcomes (1)

• Central subfield retinal thickness by OCT scan

  Anatomic outcome

  24 months

Secondary Outcomes (1)

• Best corrected visual acuity

  24 months

Other Outcomes (1)

• Need for standard of care intervention

  24 months

Study Arms (2)

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.

Drug: Fluocinolone Acetonide (FA) implant

Interventions

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.

Also known as: Steroid

Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Iris melanoma
• Opaque media
• less than 21 years of age
• Inability to give consent
• Positive pregnancy test

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cole Eye Instiute

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

Fluocinolone Acetonide; Steroids

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized to either observation (2:1) (standard of care) or intravitreal Fluocinolone Acetonide (FA) implant

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 3, 2017
• Study Start: February 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: August 4, 2021

Record last verified: 2021-08

Locations

US (1)