search
Back to results

A Study to Evaluate Ranibizumab in Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)

Primary Purpose

Choroidal Neovascularization, Age-related 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 Choroidal Neovascularization focused on measuring SAILOR, CNV, AMD, CNV secondary to AMD

Eligibility Criteria

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

Inclusion Criteria: Signed Informed Consent Form Age ≥ 50 years Subfoveal CNV secondary to AMD, with evidence of recent disease progression, as defined by any of the following (lesion is eligible if it meets any one of the following criteria): ≥ 5 letters (or ≥ 1 Snellen line) of BCVA lost within 6 months preceding Day 0\; ≥ 10% increase in lesion area, as determined by comparing a FA performed within 1 month preceding Day 0 to a FA performed within 6 months preceding Day 0; Subretinal hemorrhage associated with CNV within 1 month preceding Day 0; Classic CNV comprising > 50% of CNV lesion area BCVA, using ETDRS charts for Cohort 1 and Snellen charts for Cohort 2, of 20/40 to 20/320 (Snellen equivalent) in the study eye Exclusion Criteria: Treatment with verteporfin PDT, pegaptanib sodium, or other AMD therapy in the study eye < 30 days preceding Day 0 History of submacular surgery or other surgical intervention for AMD in the study eye Previous participation in any studies of investigational drugs within 30 days preceding Day 0 (excluding vitamins and minerals) Prior participation in a Genentech ranibizumab clinical trial Treatment with intravitreally administered (in either eye) Avastin(R) (bevacizumab) within 30 days preceding Day 0 Concurrent use of systemic anti-VEGF agents Fibrosis or atrophy involving the center of the fovea in the study eye, in the absence of a new lesion CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia Retinal pigment epithelial tear involving the macula in the study eye Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either require medical or surgical intervention during the 12-month study period to prevent or treat visual loss that might result from that condition, or, if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of BCVA over the 12-month study period Active intraocular inflammation (grade trace or above) in the study eye Current vitreous hemorrhage in the study eye History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye History of idiopathic or autoimmune-associated uveitis in either eye Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye Aphakia or pseudophakia with absence of the posterior capsule (unless it occurred as a result of a yttrium aluminum garnet [YAG] posterior capsulotomy) Spherical equivalent of the refractive error in the study eye demonstrating more than -8 diopters of myopia Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Day 0 Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with antiglaucoma medication) Concurrent use of more than one therapy for glaucoma History of glaucoma filtering surgery in the study eye History of corneal transplant in the study eye Premenopausal women not using adequate contraception Pregnancy or lactation 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 an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications Current treatment for a significant active systemic infection Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders History of recurrent significant infections or bacterial infections Inability to comply with study or follow-up procedures

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Cohort 1: The primary safety outcome measure is the incidence of SAEs (ocular and non ocular) evaluated through Month 12.
    Cohort 2: The primary safety outcome measure is the incidence of SAEs (ocular and non-ocular) and AEs (ocular and non-ocular) evaluated through Month 12.

    Secondary Outcome Measures

    Incidence of AEs (ocular and non-ocular) evaluated through Month 12
    Proportion of subjects who lose at least 15 letters in BCVA at Month 12 compared with baseline
    Mean time to retreatment following the initial three monthly loading doses
    Mean total number of injections through Month 12.

    Full Information

    First Posted
    November 8, 2005
    Last Updated
    March 6, 2014
    Sponsor
    Genentech, Inc.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00251459
    Brief Title
    A Study to Evaluate Ranibizumab in Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)
    Official Title
    A Phase IIIb, Single-Masked, Multicenter, Randomized Study to Evaluate the Safety and Tolerability of Ranibizumab in Naive and Previously Treated Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Genentech, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    This is a Phase IIIb, single-masked, 1-year multicenter study of the safety and tolerability of intravitreally administered ranibizumab in subjects with active subfoveal CNV secondary to AMD.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Choroidal Neovascularization, Age-related Macular Degeneration
    Keywords
    SAILOR, CNV, AMD, CNV secondary to AMD

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Enrollment
    5000 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    rhuFab V2 (ranibizumab)
    Primary Outcome Measure Information:
    Title
    Cohort 1: The primary safety outcome measure is the incidence of SAEs (ocular and non ocular) evaluated through Month 12.
    Title
    Cohort 2: The primary safety outcome measure is the incidence of SAEs (ocular and non-ocular) and AEs (ocular and non-ocular) evaluated through Month 12.
    Secondary Outcome Measure Information:
    Title
    Incidence of AEs (ocular and non-ocular) evaluated through Month 12
    Title
    Proportion of subjects who lose at least 15 letters in BCVA at Month 12 compared with baseline
    Title
    Mean time to retreatment following the initial three monthly loading doses
    Title
    Mean total number of injections through Month 12.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Signed Informed Consent Form Age ≥ 50 years Subfoveal CNV secondary to AMD, with evidence of recent disease progression, as defined by any of the following (lesion is eligible if it meets any one of the following criteria): ≥ 5 letters (or ≥ 1 Snellen line) of BCVA lost within 6 months preceding Day 0\; ≥ 10% increase in lesion area, as determined by comparing a FA performed within 1 month preceding Day 0 to a FA performed within 6 months preceding Day 0; Subretinal hemorrhage associated with CNV within 1 month preceding Day 0; Classic CNV comprising > 50% of CNV lesion area BCVA, using ETDRS charts for Cohort 1 and Snellen charts for Cohort 2, of 20/40 to 20/320 (Snellen equivalent) in the study eye Exclusion Criteria: Treatment with verteporfin PDT, pegaptanib sodium, or other AMD therapy in the study eye < 30 days preceding Day 0 History of submacular surgery or other surgical intervention for AMD in the study eye Previous participation in any studies of investigational drugs within 30 days preceding Day 0 (excluding vitamins and minerals) Prior participation in a Genentech ranibizumab clinical trial Treatment with intravitreally administered (in either eye) Avastin(R) (bevacizumab) within 30 days preceding Day 0 Concurrent use of systemic anti-VEGF agents Fibrosis or atrophy involving the center of the fovea in the study eye, in the absence of a new lesion CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia Retinal pigment epithelial tear involving the macula in the study eye Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either require medical or surgical intervention during the 12-month study period to prevent or treat visual loss that might result from that condition, or, if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of BCVA over the 12-month study period Active intraocular inflammation (grade trace or above) in the study eye Current vitreous hemorrhage in the study eye History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye History of idiopathic or autoimmune-associated uveitis in either eye Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye Aphakia or pseudophakia with absence of the posterior capsule (unless it occurred as a result of a yttrium aluminum garnet [YAG] posterior capsulotomy) Spherical equivalent of the refractive error in the study eye demonstrating more than -8 diopters of myopia Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Day 0 Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with antiglaucoma medication) Concurrent use of more than one therapy for glaucoma History of glaucoma filtering surgery in the study eye History of corneal transplant in the study eye Premenopausal women not using adequate contraception Pregnancy or lactation 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 an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications Current treatment for a significant active systemic infection Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders History of recurrent significant infections or bacterial infections Inability to comply with study or follow-up procedures
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tsontcho Ianchulev, M.D.
    Organizational Affiliation
    Genentech, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19643495
    Citation
    Boyer DS, Heier JS, Brown DM, Francom SF, Ianchulev T, Rubio RG. A Phase IIIb study to evaluate the safety of ranibizumab in subjects with neovascular age-related macular degeneration. Ophthalmology. 2009 Sep;116(9):1731-9. doi: 10.1016/j.ophtha.2009.05.024. Epub 2009 Jul 29.
    Results Reference
    result

    Learn more about this trial

    A Study to Evaluate Ranibizumab in Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)

    We'll reach out to this number within 24 hrs