Intravitreal Ranibizumab for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy

• Sponsor: Shields, Shields and Associates (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00540930
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Duration (Months): 24
• Patients Per Site Per Month: 16.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uveal Melanoma; Radiation Retinopathy; Radiation Maculopathy	Drug: Ranibizumab	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Randomized Control Trial of Intravitreal Ranibizumab (Lucentis) for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy for Choroidal Melanoma
• Study Start Date: Apr 1, 2007
• Anticipated Study Completion Date: Apr 1, 2009

Outcome Measures

Primary Outcome Measures

1. Presence or absence of optical coherence (OCT) evidence of macular edema. [4 months]

Secondary Outcome Measures

1. Grade of macular edema on OCT, visual acuity (LogMAR), and foveal thickness measurement on OCT at follow-up. [4 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wills Eye Institute	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• Shields, Shields and Associates

Investigators

• Principal Investigator: Carol L Shields, MD, Wills Eye Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00540930
• Other Study ID Numbers: 07-816
• First Posted: Oct 8, 2007
• Last Update Posted: Oct 8, 2007
• Last Verified: Oct 1, 2007

• Additional relevant MeSH terms: Melanoma; Macular Degeneration; Ranibizumab

Study Results

No Results Posted as of Oct 8, 2007