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Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma

NCT ID: NCT00765921

Last Updated: 2016-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Choroidal Melanoma

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1.0 mg ranibizumab

1.0 mg intravitreal injection given bi-monthly for 22 months

Group Type EXPERIMENTAL

ranibizumab

Intervention Type 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).

0.5 mg ranibizumab

0.5 mg intravitreal injection given bi-monthly for 22 months

Group Type EXPERIMENTAL

ranibizumab

Intervention Type 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).

Interventions

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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).

Intervention Type DRUG

Other Intervention Names

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rhuFab Lucentis

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

Massachusetts Eye and Ear Infirmary

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ivana Kim, M.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts Eye and Ear Infirmary

Locations

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Massachusetts Eye & Ear Infirmary

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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FVF4384s

Identifier Type: OTHER

Identifier Source: secondary_id

07-06-040

Identifier Type: -

Identifier Source: org_study_id