Steroids for Early Treatment of Radiation Retinopathy

Status Withdrawn

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03238157
Study type	Interventional
Source	The Cleveland Clinic
Contact
Status	Withdrawn
Phase	Phase 2/Phase 3
Start date	February 1, 2022
Completion date	September 1, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02222610` - Study of the Efficacy and Tolerability of Intravitreal Injections of Ranibizumab Compared to Intravitreal Injections of Ranibizumab Combined With Targeted Retinal Photocoagulation to Treat Radiation Retinopathy.	Phase 2
Active, not recruiting	`NCT04120311` - Episcleral Dexamethasone for Treatment of Macular Edema and Inflammatory Disorders of the Posterior Pole	Phase 1
Completed	`NCT00750399` - Effect of Intravitreal Ranibizumab on Radiation Retinopathy Following Plaque Brachytherapy for Choroidal Melanoma	Phase 1
Recruiting	`NCT05844982` - Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy	Phase 3
Completed	`NCT01579760` - Intravitreal Aflibercept Injection for Radiation Retinopathy	Phase 1
Completed	`NCT01334879` - High Dose Intravitreal Ranibizumab for Recalcitrant Radiation Retinopathy	Phase 1
Active, not recruiting	`NCT04120636` - Phase I Study of Episcleral Celecoxib for Treatment of Macular Edema and Inflammatory Disorders of the Posterior Pole	Phase 1
Active, not recruiting	`NCT03085784` - Intravitreal Aflibercept Injection for Radiation Retinopathy Trial	Phase 2
Terminated	`NCT01471054` - Dexamethasone Intravitreal Implant for Treatment of Macular Edema After Plaque Radiotherapy of Uveal Melanoma	Phase 2
Active, not recruiting	`NCT00540930` - Intravitreal Ranibizumab for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy	Phase 4