Intravitreal Ranibizumab for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy

Phase 4

• Conditions: Uveal Melanoma; Radiation Retinopathy; Radiation Maculopathy

• Registration Number: NCT00540930
• Lead Sponsor: Shields, Shields and Associates

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Status Verified: 2007-10
• Study First Submitted: 2007-10-05
• Study First Submitted QC: 2007-10-05
• Last Update Submitted: 2007-10-05
• Study First Posted: 2007-10-08
• Last Update Posted: 2007-10-08
• Study Completion: 2009-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Presence or absence of optical coherence (OCT) evidence of macular edema.	4 months

Secondary Outcome Measures

Name	Time	Method
Grade of macular edema on OCT, visual acuity (LogMAR), and foveal thickness measurement on OCT at follow-up.	4 months

Trial Locations

Locations (1)

Wills Eye Institute; 🇺🇸 Philadelphia, Pennsylvania, United States