Skip to main content
OpenTrials
Completed

NCT Number: NCT00765921

Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Choroidal Melanoma Eye Diseases Eye Neoplasms Glaucoma Glaucoma, Neovascular Macular Degeneration Macular Edema Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Ocular Hypertension Retinal Degeneration Retinal Diseases Uveal Diseases Uveal Melanoma Uveal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Massachusetts Eye & Ear Infirmary

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ranibizumab

Drug

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).

Other names: rhuFab, Lucentis

Primary outcomes

  1. incidence and severity of ocular adverse events and systemic adverse events

    Time frame: 12 months and 24 months after initial treatment

Secondary outcomes

  1. incidence of radiation-induced complications, vision loss and eye loss

    Time frame: 12 months and 24 months after initial treatment

Sponsors and collaborators

Lead sponsor

Massachusetts Eye and Ear Infirmary

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
Oct 3, 2008
Registry last updated
Dec 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.