Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma

A Phase I Single Center Study of Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00765921

Enrollment

Registered

2008-10-03

Start date

2008-06-30

Completion date

2016-09-30

Last updated

2016-12-02

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

Conditions

Choroidal Melanoma

Keywords

glaucoma, neovascular, macular edema, eye enucleation, antibodies, monoclonal, radiation oncology

Brief summary

The purpose of the study is to investigate the safety and tolerability of the anti-VEGF (vascular endothelial cell growth factor) treatment, ranibizumab, in combination with proton beam irradiation for the treatment of choroidal melanoma by determining the incidence and severity of ocular adverse events. Systemic adverse events will also be evaluated. A secondary objective is to assess the efficacy of ranibizumab in reducing ocular complications that can occur after irradiation.

Interventions

DRUGranibizumab

Ranibizumab dose of 0.5mg or 1.0 mg will be administered intravitreally at the time of surgery for tumor localization and then bimonthly for 22 months (total of 12 injections).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with newly diagnosed choroidal melanoma undergoing proton therapy * Tumors \>15 mm in largest diameter and/or \>5 mm in height * Tumors ≤ 15 mm in largest diameter and ≤ 5 mm in height located ≤ 3 mm from optic disc and/or macula, with best-corrected visual acuity 20/100 or better in study eye

Exclusion criteria

* History of prior treatment for choroidal melanoma * Pregnancy or lactation * Presence of diabetic retinopathy * History of retinal vascular occlusion or other retinal vascular disease * Active ocular inflammation or history of uveitis in either eye * History of uncontrolled glaucoma (defined as intraocular pressure \>30mmHg despite treatment with anti-glaucoma medication) or filtering surgery in the study eye * Previous intravitreal injections of Avastin® in the study eye or in the non-study eye within 30 days. * Concurrent use of systemic anti-VEGF therapy

Design outcomes

Primary

Measure	Time frame
incidence and severity of ocular adverse events and systemic adverse events	12 months and 24 months after initial treatment

Secondary

Measure	Time frame
incidence of radiation-induced complications, vision loss and eye loss	12 months and 24 months after initial treatment

Countries

United States

Outcome results

None listed

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