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Study of Ranibizumab Administered in Conjunction With Photodynamic Therapy With Verteporfin in Patients With Subfoveal Choroidal Neovascularization and Age-Related Macular Degeneration

Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT00288561
Collaborator
(none)
1
Location
31.9
Duration (Months)

Study Details

Study Description

Brief Summary

Ranibizumab is derived from a murine monoclonal anti- vascular endothelial growth factor (VEGF) antibody and can penetrate through the many retinal cell layers following intravitreal injection. The present study is directed towards the assessment of ranibizumab administered on the same day in combination with verteporfin in patients with subfoveal CNV secondary to ARMD

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Open-Label, Multicenter, Phase II Study Assessing the Safety of Ranibizumab Administered in Conjunction With Photodynamic Therapy With Verteporfin in Patients With Occult or Predominately Classic Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (ARMD)
Study Start Date :
Nov 1, 2004
Actual Study Completion Date :
Jul 1, 2007

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients 50 years of age or greater who have provided written informed consent

    • Patients with subfoveal choroidal neovascularization lesions secondary to AMD, either predominantly classic or occult with no classic component

    • Patients who have a BCVA score between 73 and 24 letters, inclusively, in the study eye using ETDRS (approximately 20/40 to 20/320)

    • Willing to return for all scheduled visits

    Exclusion Criteria:
      • Patients who have a BCVA of < 34 letters in both eyes (legally blind is defined as bilateral vision below 20/200 or less than 34 letters)

    • Prior treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy

    • Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)

    Other protocol-defined inclusion/exclusion criteria may apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Basel Switzerland

    Sponsors and Collaborators

    • Novartis

    Investigators

    • Study Chair: Novartis Customer Information, Novartis - Including Sites in Germany

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00288561
    Other Study ID Numbers:
    • CRFB002B2201
    First Posted:
    Feb 8, 2006
    Last Update Posted:
    Jun 19, 2008
    Last Verified:
    Jun 1, 2008
    Keywords provided by , ,
    ARMD, ranibizumab, verteporfin
    Additional relevant MeSH terms:
    Macular Degeneration
    Choroidal Neovascularization
    Neovascularization, Pathologic
    Ranibizumab

    Study Results

    No Results Posted as of Jun 19, 2008