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Safety Study of 2.0mg Lucentis to Treat Polypoidal Choroidal Vasculopathy

NCT01469156 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-12-12

Study results available
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Summary

This Phase I/II study will investigate the safety and tolerability of intravitreally administered 0.5mg and 1.0 or 2.0mg Ranibizumab in three monthly doses followed by a 9 month period of criteria-based, as-needed retreatment and 12 month of drug safety follow up in subjects with exudative polypoidal choroidal vasculopathy (PCV) for a total of 24 months.

Conditions

  • Polypoidal Choroidal Vasculopathy

Interventions

DRUG

ranibizumab 0.5 or 2.0 mg/0.05 cc

ranibizumab (3:1 ratio of 2mg:0.5 mg ranibizumab) administered in three initial monthly doses followed by a 9 month period of criteria-based, as-needed retreatment and 12 month off drug safety follow up.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Southeast Retina Center, Georgia

    lead OTHER

Principal Investigators

  • Dennis M. Marcus, M.D. · Southeast Retina Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2015-02-28
Completion
2015-02-28

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 NCT01469156 on ClinicalTrials.gov