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Intravitreal Ranibizumab for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00540930
Enrollment
400
Registered
2007-10-08
Start date
2007-04-30
Completion date
2009-04-30
Last updated
2007-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiation Maculopathy, Radiation Retinopathy, Uveal Melanoma

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.

Interventions

DRUGRanibizumab

Intravitreal Ranibizumab 0.5mg at the time of radioactive plaque insertion

Sponsors

Shields, Shields and Associates
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026