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Effect of Intravitreal Ranibizumab on Radiation Retinopathy Following Plaque Brachytherapy for Choroidal Melanoma

NCT00750399 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2012-04-26

No results posted yet for this study

Summary

This is a Phase I clinical trial to test the safety and tolerability of intravitreal ranibizumab in the treatment of radiation retinopathy following plaque brachytherapy for patients with choroidal melanoma using the incidence and severity of events criteria.

The secondary objective is to assess the efficacy of intravitreal ranibizumab on regression of radiation retinopathy by ophthalmic examination, fundus photography, fluorescein angiography, and optical coherence tomography, as well as visual acuity.

Conditions

  • Radiation Retinopathy
  • Choroidal Melanoma

Interventions

DRUG

Ranibizumab

intravitreal ranibizumab monthly for 4 months, and then every month thereafter until month 12.

DRUG

ranibizumab

intravitreal ranibizumab 0.5 mg

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • The New York Eye Cancer Center

    lead OTHER

Principal Investigators

  • Paul T Finger, MD · The New York Eye Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00750399 on ClinicalTrials.gov