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An Extension Study to Evaluate Safety and Tolerability of Ranibizumab in Macular Edema Secondary to Retinal Vein Occlusion (Cohort 2)

Primary Purpose

Macular Edema, Retinal Vein Occlusion

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ranibizumab 0.5 mg
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Edema focused on measuring CNV, Lucentis, AMD, Age-related macular degeneration, RVO, Macular edema secondary to retinal vein occlusion

Eligibility Criteria

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

Inclusion Criteria:

  • Signed informed consent form
  • The 6-month treatment and 6-month observation phases (12 months total) of a Genentech-sponsored ranibizumab study for RVO (FVF4165g or FVF4166g)
  • Expectation by the investigator that the subject may potentially benefit from intravitreal anti-vascular endothelial growth factor (VEGF) treatment

Exclusion Criteria:

  • History of intraocular surgery (including cataract extraction, scleral buckle, etc.) within 1 month prior to Day 0 of this extension study
  • Concurrent use of systemic anti-VEGF agents
  • Use of RVO treatments not approved by the Food and Drug Administration (FDA) in the study eye
  • Use of intravitreal bevacizumab in the study eye and/or fellow eye
  • Macular edema in the study eye due to other causes than RVO such as diabetes
  • 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
  • Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 30 mmHg despite treatment with antiglaucoma medication)
  • Pregnancy or lactation
  • Premenopausal women not using adequate contraception
  • 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 active systemic infection
  • Inability to comply with study or follow-up procedures

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Ranibizumab 0.5 mg

    Arm Description

    Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) for 24 months.

    Outcomes

    Primary Outcome Measures

    Number of Participants With Ocular Adverse Events in the Study Eye
    Number of participants with: any ocular adverse events, ocular adverse events causing treatment discontinuation, ocular serious adverse events, intraocular inflammation and cataracts that occurred in the study eye. Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded.
    Number of Participants With Non-ocular Adverse Events
    Number of participants with non-ocular adverse events (not occurring in the eye) in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation and death. Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded. Additional information about adverse events can be found in the adverse events section.

    Secondary Outcome Measures

    Change From Baseline in the Best Corrected Visual Acuity (BCVA)
    Change from baseline in then BCVA was assessed by the number of letters a patient could read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart at a Starting Test Distance of 4 Meters. An increase in the number of letters read indicates improvement in visual acuity.
    Change From Baseline in Central Foveal Thickness at Month 6 and Month 12
    Change from baseline in Central foveal (retinal) thickness was assessed by Optical Coherence Tomography (OCT). OCT was conducted at the study sites by personnel who were certified by the University of Wisconsin Fundus Photograph Reading Center.
    Change From Baseline in Visual Function Composite Score, as Measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25)
    NEI VFQ-25 is a 25 item questionnaire that assesses visual function and quality of life for a total possible score of 0 to 100. A higher score represents better functioning. The change from baseline is calculated at Month 12 and Month 24. Participants are grouped according to the treatment they received in initial studies FVF4165g BRAVO (NCT00486018) and FVF4166g CRUISE (NCT00485836).

    Full Information

    First Posted
    September 26, 2011
    Last Updated
    December 5, 2011
    Sponsor
    Genentech, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01442064
    Brief Title
    An Extension Study to Evaluate Safety and Tolerability of Ranibizumab in Macular Edema Secondary to Retinal Vein Occlusion (Cohort 2)
    Official Title
    An Open-Label, Multicenter Extension Study to Evaluate the Safety and Tolerability of Ranibizumab in Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD) or Macular Edema Secondary to Retinal Vein Occlusion (RVO) Who Have Completed a Genentech-Sponsored Ranibizumab Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2008 (undefined)
    Primary Completion Date
    July 2010 (Actual)
    Study Completion Date
    July 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Genentech, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    This is an open-label, multicenter, extension study of intravitreally administered ranibizumab in two cohorts. The first cohort (reported separately under FVF3426g, NCT00379795) enrolled subjects with primary or recurrent Choroidal Neovascularization (CNV) secondary to Age-Related Macular Degeneration (AMD) who completed the treatment phase of a Genentech sponsored study (FVF2598g (NCT00056836), FVF2587g (NCT00061594), or FVF2428g (NCT00056823)). The second cohort (reported here) enrolled subjects with macular edema secondary to Retinal Vein Occlusion (RVO) who completed the 6-month treatment and 6-month observation phases (12 months total) of a Genentech sponsored study (FVF4165g (NCT00486018) or FVF4166g (NCT00485836)). Patients were enrolled within 14 days of completion of the previous study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Macular Edema, Retinal Vein Occlusion
    Keywords
    CNV, Lucentis, AMD, Age-related macular degeneration, RVO, Macular edema secondary to retinal vein occlusion

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    608 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ranibizumab 0.5 mg
    Arm Type
    Experimental
    Arm Description
    Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) for 24 months.
    Intervention Type
    Drug
    Intervention Name(s)
    Ranibizumab 0.5 mg
    Other Intervention Name(s)
    Lucentis
    Intervention Description
    Ranibizumab intravitreal injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year).
    Primary Outcome Measure Information:
    Title
    Number of Participants With Ocular Adverse Events in the Study Eye
    Description
    Number of participants with: any ocular adverse events, ocular adverse events causing treatment discontinuation, ocular serious adverse events, intraocular inflammation and cataracts that occurred in the study eye. Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded.
    Time Frame
    Up to 24 months
    Title
    Number of Participants With Non-ocular Adverse Events
    Description
    Number of participants with non-ocular adverse events (not occurring in the eye) in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation and death. Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded. Additional information about adverse events can be found in the adverse events section.
    Time Frame
    Up to 24 months
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in the Best Corrected Visual Acuity (BCVA)
    Description
    Change from baseline in then BCVA was assessed by the number of letters a patient could read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart at a Starting Test Distance of 4 Meters. An increase in the number of letters read indicates improvement in visual acuity.
    Time Frame
    Baseline (Day 0 of extension study), Months 6, 12, 18, and 24
    Title
    Change From Baseline in Central Foveal Thickness at Month 6 and Month 12
    Description
    Change from baseline in Central foveal (retinal) thickness was assessed by Optical Coherence Tomography (OCT). OCT was conducted at the study sites by personnel who were certified by the University of Wisconsin Fundus Photograph Reading Center.
    Time Frame
    Baseline (Day 0 of extension study), Months 6 and 12
    Title
    Change From Baseline in Visual Function Composite Score, as Measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25)
    Description
    NEI VFQ-25 is a 25 item questionnaire that assesses visual function and quality of life for a total possible score of 0 to 100. A higher score represents better functioning. The change from baseline is calculated at Month 12 and Month 24. Participants are grouped according to the treatment they received in initial studies FVF4165g BRAVO (NCT00486018) and FVF4166g CRUISE (NCT00485836).
    Time Frame
    Baseline (Day 0 of extension study), Months 12 and 24

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Signed informed consent form The 6-month treatment and 6-month observation phases (12 months total) of a Genentech-sponsored ranibizumab study for RVO (FVF4165g or FVF4166g) Expectation by the investigator that the subject may potentially benefit from intravitreal anti-vascular endothelial growth factor (VEGF) treatment Exclusion Criteria: History of intraocular surgery (including cataract extraction, scleral buckle, etc.) within 1 month prior to Day 0 of this extension study Concurrent use of systemic anti-VEGF agents Use of RVO treatments not approved by the Food and Drug Administration (FDA) in the study eye Use of intravitreal bevacizumab in the study eye and/or fellow eye Macular edema in the study eye due to other causes than RVO such as diabetes 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 Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 30 mmHg despite treatment with antiglaucoma medication) Pregnancy or lactation Premenopausal women not using adequate contraception 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 active systemic infection Inability to comply with study or follow-up procedures
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Phillip Lai, M.D.
    Organizational Affiliation
    Genentech, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    An Extension Study to Evaluate Safety and Tolerability of Ranibizumab in Macular Edema Secondary to Retinal Vein Occlusion (Cohort 2)

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