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Extension Study of rhuFab V2 in Subjects With Neovascular Age-Related Macular Degeneration (AMD)

Primary Purpose

Macular Degeneration

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
rhuFab V2 (ranibizumab)
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring AMD, Neovascular age-related macular degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Signed informed consent and authorization of use and disclosure of protected health information Age >=50 years Completion of the treatment phase of a Genentech sponsored Phase I or I/II ranibizumab protocol (FVF1770g, FVF2128g, or FVF2425g) Exclusion Criteria: CNV in either eye due to other causes such as ocular histoplasmosis, trauma, or pathologic myopia Active intraocular inflammation (grade trace or above) in the study eye Current vitreous hemorrhage in the study eye Subretinal hemorrhage in the study eye that involves the fovea, if the size of the hemorrhage is either >=50% of the total lesion area or >=1 DA in size Intraocular surgery (including cataract surgery) in the study eye within 1 month preceding Week 0 Uncontrolled glaucoma in the study eye (defined as intraocular pressure >=30 mmHg despite treatment with anti-glaucoma medication) Premenopausal women not using adequate contraception Laser photocoagulation (subfoveal, juxtafoveal, or extrafoveal) in the study eye within 30 days preceding Week 0 Prior treatment with external-beam radiation therapy or transpupillary thermotherapy (TTT) in the study eye Previous treatment with verteporfin in the study eye within 30 days preceding Week 0 Treatment with verteporfin in the non-study eye within 7 days preceding Week 0 History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye Previous participation in a clinical trial (for either eye) involving antiangiogenic drugs other than ranibizumab (e.g., pegaptanib, anecortave acetate, protein kinase C inhibitors, etc.) Previous participation in any studies of investigational drugs within 1 month preceding Week 0 (excluding vitamins and minerals studies) Discontinuation from a ranibizumab study due to an adverse event judged by the investigator to be possibly or probably related to ranibizumab History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk from treatment complications Inability to comply with study or follow up procedures

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 4, 2004
    Last Updated
    March 25, 2014
    Sponsor
    Genentech, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00095433
    Brief Title
    Extension Study of rhuFab V2 in Subjects With Neovascular Age-Related Macular Degeneration (AMD)
    Official Title
    An Extension Study to Evaluate the Safety and Tolerability of Multiple-Dose Intravitreal Injections of rhuFab V2 in Subjects With Neovascular Age-Related Macular Degeneration Who Have Completed the Treatment Phase of a Genentech-Sponsored Phase I or Phase I/II rhuFab V2 Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2002 (undefined)
    Primary Completion Date
    August 2006 (Actual)
    Study Completion Date
    August 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Genentech, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    This is a Phase III, open-label, multicenter extension study of intravitreally administered ranibizumab in subjects with primary or recurrent subfoveal choroidal neovascularization (CNV) secondary to AMD who have completed the treatment phase of a Genentech sponsored Phase I or Phase I/II ranibizumab protocol (FVF1770g, FVF2128g, or FVF2425g).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Macular Degeneration
    Keywords
    AMD, Neovascular age-related macular degeneration

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Masking
    None (Open Label)
    Enrollment
    100 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    rhuFab V2 (ranibizumab)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Signed informed consent and authorization of use and disclosure of protected health information Age >=50 years Completion of the treatment phase of a Genentech sponsored Phase I or I/II ranibizumab protocol (FVF1770g, FVF2128g, or FVF2425g) Exclusion Criteria: CNV in either eye due to other causes such as ocular histoplasmosis, trauma, or pathologic myopia Active intraocular inflammation (grade trace or above) in the study eye Current vitreous hemorrhage in the study eye Subretinal hemorrhage in the study eye that involves the fovea, if the size of the hemorrhage is either >=50% of the total lesion area or >=1 DA in size Intraocular surgery (including cataract surgery) in the study eye within 1 month preceding Week 0 Uncontrolled glaucoma in the study eye (defined as intraocular pressure >=30 mmHg despite treatment with anti-glaucoma medication) Premenopausal women not using adequate contraception Laser photocoagulation (subfoveal, juxtafoveal, or extrafoveal) in the study eye within 30 days preceding Week 0 Prior treatment with external-beam radiation therapy or transpupillary thermotherapy (TTT) in the study eye Previous treatment with verteporfin in the study eye within 30 days preceding Week 0 Treatment with verteporfin in the non-study eye within 7 days preceding Week 0 History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye Previous participation in a clinical trial (for either eye) involving antiangiogenic drugs other than ranibizumab (e.g., pegaptanib, anecortave acetate, protein kinase C inhibitors, etc.) Previous participation in any studies of investigational drugs within 1 month preceding Week 0 (excluding vitamins and minerals studies) Discontinuation from a ranibizumab study due to an adverse event judged by the investigator to be possibly or probably related to ranibizumab History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk from treatment complications Inability to comply with study or follow up procedures

    12. IPD Sharing Statement

    Learn more about this trial

    Extension Study of rhuFab V2 in Subjects With Neovascular Age-Related Macular Degeneration (AMD)

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