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Ranibizumab (Lucentis) for Macular Edema Secondary to Vein Occlusions

NCT00407355 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2013-12-04

Study results available
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Summary

Central and branch retinal vein occlusions are major causes of visual loss. Hemorrhage and capillary nonperfusion, when they involve the macula, can contribute to visual loss, but the major cause is macular edema. Focal and grid laser photocoagulation can sometimes provide benefit in patients with macular edema due to branch vein occlusions, but several laser treatments are often needed and recovery of vision can be very slow and incomplete 1. Laser photocoagulation does not provide benefit for macular edema due to central vein occlusions 2. Therefore, new treatments are needed.The objective of this study is to assess the bioactivity of 3 intravitreous injections 0.5 mg or 0.3 mg of ranibizumab in patients with macular edema due to central and branch retinal vein occlusions and correlate activity with peak and trough aqueous levels. The purpose of this research protocol is pilot study to determine if a randomized placebo controlled trial is warranted.

Conditions

  • Macular Edema
  • Retinal Vein Occlusion

Interventions

DRUG

Intravitreal injection of ranibizumab .3 dose

PRN every 30 days withing retreatment criteria

DRUG

Intravitreal injection of Ranibizumab .5 dose

Intravitreal injection of Ranibizumab .5 dose every 30 days PRN with retreatment criteria

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Peter A Campochiaro, MD

    lead OTHER

Principal Investigators

  • Peter A Campochiaro, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States

Study Locations

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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 NCT00407355 on ClinicalTrials.gov