Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma

December 1, 2016 updated by: Massachusetts Eye and Ear Infirmary

A Phase I Single Center Study of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts Eye & Ear Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1.0 mg ranibizumab
1.0 mg intravitreal injection given bi-monthly for 22 months
Drug: ranibizumab
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:
  • Lucentis
  • rhuFab
Experimental: 0.5 mg ranibizumab
0.5 mg intravitreal injection given bi-monthly for 22 months
Drug: ranibizumab
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:
  • Lucentis
  • rhuFab

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts Eye and Ear Infirmary

Collaborators

Genentech, Inc.

Investigators

  • Principal Investigator: Ivana Kim, M.D., Massachusetts Eye and Ear Infirmary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

October 2, 2008

First Submitted That Met QC Criteria

October 2, 2008

First Posted (Estimate)

October 3, 2008

Study Record Updates

Last Update Posted (Estimate)

December 2, 2016

Last Update Submitted That Met QC Criteria

December 1, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-06-040
  • FVF4384s (Other Identifier: Genentech)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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