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Lucentis in Advanced Macular Degeneration

NCT00896779 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-06-29

Study results available
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Summary

Patients with low vision (visual acuity 20/400 or worse) were excluded from the large Phase III ranibizumab clinical trials. It is not known if treatment with ranibizumab results in improved visual function in such patients.Since ranibizumab has been shown to be the most effective therapy for exudative macular degeneration we propose to treat all patients in this study with monthly ranibizumab intravitreal injections.

Patients will be assigned to one of two groups by the flip of a coin. Group #1 for "heads" and Group #2 for "tails".

Group #1 patients will be treated for 3 monthly injections of 0.5 mg of ranibizumab and then as needed therapy.

Group #2 will be treated with 6 monthly injections of 0.5 mg of ranibizumab and then as needed therapy.

Conditions

  • Macular Degeneration

Interventions

DRUG

ranibizumab

Group 1 - 0.5mg intravitreal injection every month for 3 months then as needed for 12 months Group 2 -0.5mg intravitreal injection every month for 6 months then as needed for 12 months

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • California Pacific Medical Center

    collaborator OTHER

  • Pacific Eye Associates

    collaborator OTHER

  • Steven R. Sanislo

    lead OTHER

Principal Investigators

  • Dr. Steven R. Sanislo · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2013-09-30
Completion
2013-09-30

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 NCT00896779 on ClinicalTrials.gov