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Intravitreal Injections of rhuFab V2 in Combination With Visudyne in Subjects With Age Related Macular Degeneration (AMD)

Primary Purpose

Age-Related Maculopathy

Status
Completed
Phase
Phase 1
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 Age-Related Maculopathy focused on measuring AMD

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 Eligibility for treatment with PDT using verteporfin in the study eye according to the Visudyne(R) product labeling Treatment with verteporfin anticipated or expected Primary or recurrent subfoveal choroidal neovascularization (CNV) lesions secondary to AMD in the study eye A classic CNV component (well-demarcated hyperfluorescence boundaries in the early phase of the fluorescein angiogram) that is >=50% of the total lesion area Total lesion size >=5400 um in greatest linear dimension (GLD) Best corrected visual acuity, using ETDRS charts, of 20/40 to 20/320 (Snellen equivalent) in the study eye Exclusion Criteria: Treatment with verteporfin in the study eye less than 3 months preceding Day 0 Treatment with verteporfin in the non-study eye less than 7 days preceding Day 0 More than three prior treatments with verteporfin PDT in the study eye within 12 months preceding Day 0 Prior treatment with external-beam radiation therapy or transpupillary thermotherapy in the study eye Previous participation in a clinical trial (for either eye) involving antiangiogenic drugs (pegaptanib, rhuFab V2, anecortave acetate, protein kinase C inhibitors, etc.) Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye Previous subfoveal focal laser photocoagulation in the study eye Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0 History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals studies) Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either >=50% of the total lesion area or >=1 disc area in size Subfoveal fibrosis or atrophy in the study eye Clinical or angiographic evidence of retinal angiomatous proliferation in the study eye, if there is also no angiographic evidence of classic CNV CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia Retinal pigment epithelium tear involving the macula in the study eye Any concurrent intraocular condition (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, either could require medical or surgical intervention during the 24-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 best corrected visual acuity over the 24-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. Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye Aphakia or absence of the posterior capsule in the study eye Spherical equivalent of the refractive error in the study eye demonstrating more than -8 diopters of myopia Intraocular surgery (including cataract surgery) on the study eye within 1 month preceding Day 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 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. Current treatment for active systemic infection Contraindications to verteporfin photodynamic therapy (as determined by the investigator) History of allergy to fluorescein, not amenable to treatment Inability to dilate pupils to >=6 mm in diameter Inability to comply with study or follow up procedures

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    March 24, 2003
    Last Updated
    June 19, 2013
    Sponsor
    Genentech, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00056823
    Brief Title
    Intravitreal Injections of rhuFab V2 in Combination With Visudyne in Subjects With Age Related Macular Degeneration (AMD)
    Official Title
    A Phase I/II, Single-Masked, Multicenter Study of the Safety, Tolerability, and Efficacy of Multiple-Dose Intravitreal Injections of rhuFab V2 in Combination With Verteporfin (Visudyne(R)) Photodynamic Therapy in Subjects With Neovascular Age Related Macular Degeneration
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 2005 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    The primary purpose of this study is to determine if injections of rhuFab V2 into the eye in combination with verteporfin photodynamic therapy (PDT) is a safe and efficacious treatment for patients with age-related macular degeneration.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Age-Related Maculopathy
    Keywords
    AMD

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    168 (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 Eligibility for treatment with PDT using verteporfin in the study eye according to the Visudyne(R) product labeling Treatment with verteporfin anticipated or expected Primary or recurrent subfoveal choroidal neovascularization (CNV) lesions secondary to AMD in the study eye A classic CNV component (well-demarcated hyperfluorescence boundaries in the early phase of the fluorescein angiogram) that is >=50% of the total lesion area Total lesion size >=5400 um in greatest linear dimension (GLD) Best corrected visual acuity, using ETDRS charts, of 20/40 to 20/320 (Snellen equivalent) in the study eye Exclusion Criteria: Treatment with verteporfin in the study eye less than 3 months preceding Day 0 Treatment with verteporfin in the non-study eye less than 7 days preceding Day 0 More than three prior treatments with verteporfin PDT in the study eye within 12 months preceding Day 0 Prior treatment with external-beam radiation therapy or transpupillary thermotherapy in the study eye Previous participation in a clinical trial (for either eye) involving antiangiogenic drugs (pegaptanib, rhuFab V2, anecortave acetate, protein kinase C inhibitors, etc.) Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye Previous subfoveal focal laser photocoagulation in the study eye Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0 History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals studies) Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either >=50% of the total lesion area or >=1 disc area in size Subfoveal fibrosis or atrophy in the study eye Clinical or angiographic evidence of retinal angiomatous proliferation in the study eye, if there is also no angiographic evidence of classic CNV CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia Retinal pigment epithelium tear involving the macula in the study eye Any concurrent intraocular condition (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, either could require medical or surgical intervention during the 24-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 best corrected visual acuity over the 24-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. Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye Aphakia or absence of the posterior capsule in the study eye Spherical equivalent of the refractive error in the study eye demonstrating more than -8 diopters of myopia Intraocular surgery (including cataract surgery) on the study eye within 1 month preceding Day 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 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. Current treatment for active systemic infection Contraindications to verteporfin photodynamic therapy (as determined by the investigator) History of allergy to fluorescein, not amenable to treatment Inability to dilate pupils to >=6 mm in diameter Inability to comply with study or follow up procedures

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23361508
    Citation
    Xu L, Lu T, Tuomi L, Jumbe N, Lu J, Eppler S, Kuebler P, Damico-Beyer LA, Joshi A. Pharmacokinetics of ranibizumab in patients with neovascular age-related macular degeneration: a population approach. Invest Ophthalmol Vis Sci. 2013 Mar 5;54(3):1616-24. doi: 10.1167/iovs.12-10260.
    Results Reference
    derived
    PubMed Identifier
    18321465
    Citation
    Antoszyk AN, Tuomi L, Chung CY, Singh A; FOCUS Study Group. Ranibizumab combined with verteporfin photodynamic therapy in neovascular age-related macular degeneration (FOCUS): year 2 results. Am J Ophthalmol. 2008 May;145(5):862-74. doi: 10.1016/j.ajo.2007.12.029. Epub 2008 Mar 5.
    Results Reference
    derived

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    Intravitreal Injections of rhuFab V2 in Combination With Visudyne in Subjects With Age Related Macular Degeneration (AMD)

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