Overview

This trial is active, not recruiting.

Conditions uveal melanoma, radiation retinopathy, radiation maculopathy
Treatment ranibizumab
Phase phase 4
Target VEGF
Sponsor Shields, Shields and Associates
Start date April 2007
End date April 2009
Trial size 400 participants
Trial identifier NCT00540930, 07-816

Summary

Uveal Melanoma is the most common primary intraocular malignancy in adulthood. Eye preserving treatments can deliver equivalent life prognosis in the management of small and medium sized uveal melanomas, as compared to enucleation. Plaque radiotherapy has emerged as the most common eye-preserving treatment in the current management of uveal melanoma, but is complicated by visual loss in approximately 70% of patients at 10 years follow-up. Strategies for the prevention and early treatment of radiation retinopathy/maculopathy need to be developed to improve visual outcomes following plaque treatment. Ranibizumab (Lucentis) is the antigen binding fragment of a recombinant, humanized monoclonal antibody, which inhibits the activity of vascular endothelial growth factor A, a mediator in the development of choroidal neovascularization. Lucentis is commonly used in the eye for eye conditions such as age related macular degeneration. This study will investigate the possible benefit of Anti-VEGF therapy (Lucentis) in reducing the incidence of radiation complications following plaque radiation for uveal melanoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention

Primary Outcomes

Measure
Presence or absence of optical coherence (OCT) evidence of macular edema.
time frame: 4 months

Secondary Outcomes

Measure
Grade of macular edema on OCT, visual acuity (LogMAR), and foveal thickness measurement on OCT at follow-up.
time frame: 4 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Age >18 years - new diagnosis of choroidal melanoma - scheduled for plaque radiotherapy at Wills Eye Health System Exclusion Criteria: - Pre-existing retinal disorders (i.e. age-related macular degeneration, diabetic maculopathy, retinal vascular occlusion, macular hole, surface wrinkling retinopathy) - prior retinal detachment - media opacities precluding accurate OCT imaging - history of glaucoma - pregnancy - age <18 years.

Additional Information

Official title A Randomized Control Trial of Intravitreal Ranibizumab (Lucentis) for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy for Choroidal Melanoma
Principal investigator Carol L Shields, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2007.
Information provided to ClinicalTrials.gov by Shields, Shields and Associates.