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A Study of rhuFab V2 (Ranibizumab) in Subjects With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD)

Primary Purpose

Macular Degeneration

Status
Completed
Phase
Phase 3
Locations
United States
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 Subfoveal neovascular, Age-related macular degeneration, AMD, Wet AMD

Eligibility Criteria

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

Inclusion Criteria: Signed informed consent Age >=50 years Active primary or recurrent subfoveal CNV lesions secondary to AMD in the study eye Total area of CNV (including both classic and occult components) encompassed within the lesion >= 50% of the total lesion area Total lesion area <=12 disc areas in size Best corrected visual acuity (BCVA), using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts, of 20/40 to 20/320 (Snellen equivalent) in the study eye Exclusion Criteria: Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy in the study eye Treatment with verteporfin in the nonstudy eye <7 days preceding Day 0 Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, 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 surgery in the study eye History of 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) 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 Fibrosis or atrophy involving the center of the fovea in the study eye 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: (1) Require medical or surgical intervention during the 24-month study period to prevent or treat visual loss that might result from that condition, or (2) If allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of BCVA 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) in the study eye within 2 months preceding Day 0 Uncontrolled glaucoma in the study eye (defined as intraocular pressure >=30 mmHg despite treatment with antiglaucoma medication) History of glaucoma filtering surgery in the study eye History of corneal transplant in the study eye 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 for treatment complications Current treatment for active systemic infection History of allergy to fluorescein, not amenable to treatment Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality to be analyzed and graded by the central reading center Inability to comply with study or follow up procedures

Sites / Locations

  • Trial Information Support Line

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 30, 2004
Last Updated
June 19, 2013
Sponsor
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00090623
Brief Title
A Study of rhuFab V2 (Ranibizumab) in Subjects With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD)
Official Title
A Phase IIIb, Multicenter, Randomized, Double Masked, Sham Injection-Controlled Study of the Efficacy and Safety of Ranibizumab in Subjects With Subfoveal Choroidal Neovascularization (CNV) With or Without Classic CNV Secondary to Age Related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (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 a phase III, multicenter, randomized, double masked, sham injection-controlled study of the efficacy and safety of intravitreally administered ranibizumab in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
Subfoveal neovascular, Age-related macular degeneration, AMD, Wet AMD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Allocation
Randomized
Enrollment
180 (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 Age >=50 years Active primary or recurrent subfoveal CNV lesions secondary to AMD in the study eye Total area of CNV (including both classic and occult components) encompassed within the lesion >= 50% of the total lesion area Total lesion area <=12 disc areas in size Best corrected visual acuity (BCVA), using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts, of 20/40 to 20/320 (Snellen equivalent) in the study eye Exclusion Criteria: Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy in the study eye Treatment with verteporfin in the nonstudy eye <7 days preceding Day 0 Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, 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 surgery in the study eye History of 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) 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 Fibrosis or atrophy involving the center of the fovea in the study eye 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: (1) Require medical or surgical intervention during the 24-month study period to prevent or treat visual loss that might result from that condition, or (2) If allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of BCVA 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) in the study eye within 2 months preceding Day 0 Uncontrolled glaucoma in the study eye (defined as intraocular pressure >=30 mmHg despite treatment with antiglaucoma medication) History of glaucoma filtering surgery in the study eye History of corneal transplant in the study eye 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 for treatment complications Current treatment for active systemic infection History of allergy to fluorescein, not amenable to treatment Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality to be analyzed and graded by the central reading center Inability to comply with study or follow up procedures
Facility Information:
Facility Name
Trial Information Support Line
City
Denver
State/Province
Colorado
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18222192
Citation
Regillo CD, Brown DM, Abraham P, Yue H, Ianchulev T, Schneider S, Shams N. Randomized, double-masked, sham-controlled trial of ranibizumab for neovascular age-related macular degeneration: PIER Study year 1. Am J Ophthalmol. 2008 Feb;145(2):239-248. doi: 10.1016/j.ajo.2007.10.004.
Results Reference
result
PubMed Identifier
20683380
Citation
Barbazetto I, Saroj N, Shapiro H, Wong P, Freund KB. Dosing regimen and the frequency of macular hemorrhages in neovascular age-related macular degeneration treated with ranibizumab. Retina. 2010 Oct;30(9):1376-85. doi: 10.1097/IAE.0b013e3181dcfb0b.
Results Reference
derived
PubMed Identifier
20598667
Citation
Abraham P, Yue H, Wilson L. Randomized, double-masked, sham-controlled trial of ranibizumab for neovascular age-related macular degeneration: PIER study year 2. Am J Ophthalmol. 2010 Sep;150(3):315-324.e1. doi: 10.1016/j.ajo.2010.04.011. Epub 2010 Jul 3.
Results Reference
derived

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A Study of rhuFab V2 (Ranibizumab) in Subjects With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD)

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