Intravitreal Ranibizumab for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy

Uveal Melanoma Clinical Trial

Official title:

A Randomized Control Trial of Intravitreal Ranibizumab (Lucentis) for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy for Choroidal Melanoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00540930
• Other study ID #: 07-816
• Status: Active, not recruiting
• Phase: Phase 4
• First received: October 5, 2007
• Last updated: October 5, 2007
• Start date: April 2007
• Est. completion date: April 2009

Study information

• Verified date: October 2007
• Source: Shields, Shields and Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Radiation Maculopathy
• Radiation Retinopathy
• Uveal Melanoma

Intervention

Drug:
• Ranibizumab
Intravitreal Ranibizumab 0.5mg at the time of radioactive plaque insertion

Locations

Country	Name	City	State
United States	Wills Eye Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Shields, Shields and Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence or absence of optical coherence (OCT) evidence of macular edema.		4 months
Secondary	Grade of macular edema on OCT, visual acuity (LogMAR), and foveal thickness measurement on OCT at follow-up.		4 months