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Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT00765921•Massachusetts Eye and Ear Infirmary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (1)

Massachusetts Eye & Ear Infirmary

Boston, Massachusetts, United States

Key Dates

Start Date

June 1, 2008

Primary Completion Date

February 1, 2016

Completion Date

September 1, 2016

Last Updated

December 2, 2016

Enrollment

ACTUAL participants

Conditions

Choroidal Melanoma

Interventions

ranibizumab

DRUG

A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma

NCT06007690

Choroidal MelanomaIndeterminate Lesions+2 more

View study

RECRUITING

A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma

NCT03941379

Choroidal MelanomaIndeterminate Lesions of Eye

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 2, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma

Inclusion Criteria

Exclusion Criteria

A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma

A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma

Study of Circulating Tumoral DNA in Metastatic Choroidal Melanoma

Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma

Study in Subjects With Small Primary Choroidal Melanoma

Prospective Group-Matched Study With Belzupacap Sarotalocan (Bel-sar; AU-011) or Plaque Radiotherapy for Primary Indeterminate Lesions or Choroidal Melanoma (IL/ CM)