- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00284089
Safety and Efficacy of Ranibizumab in Japanese Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration
Open-label Multicenter, Phase I/II Study Assessing the Safety and Efficacy of Ranibizumab (RFB002) in Japanese Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Tokyo, Japan
- Novartis
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- Male or female patients 50 years of age or greater
- Patients with primary or recurrent subfoveal CNV secondary to AMD
- Patients who have a BCVA score between 73 and 24 letters in the study eye using ETDRS-like grading charts (approximately 20/40 to 20/320)
Exclusion Criteria
1. No prior treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy
Extension Phase
Inclusion criteria:
- Personally provided written informed consent to participate in the extension phase.
- Patients with subfoveal CNV secondary to AMD who had completed the multiple dose phase in either of the ranibizumab groups (Group A or B).
- Patients could participate in the extension phase even if they failed to do so on the day of the exit visit in the multiple dose phase (Group A and B), regardless of the time elapsed until the participation in the extension phase.
Exclusion criteria:
- Received anti-angiogenic drugs (bevacizumab, pegaptanib, ranibizumab, anecortave acetate, corticosteroids or protein kinase C inhibitors, etc.) or
- Participated in any clinical study of an investigational drug other than this one during the period between the exit visit of the multiple dose phase and the start in the extension phase, if they failed to be enrolled into the extension on the day of the exit visit. Patients were to be excluded even when the fellow eye was treated with any of these drugs.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Group A: Ranibizumab 0.3 mg
In the single dose phase, all patients randomized in Group A received a single intravitreal injection of 0.3 mg of ranibizumab into the study eye.
Those patients who successfully completed this phase entered the multiple dose phase, where they received an intravitreal injection of 0.3 mg of ranibizumab once a month for an additional 11 months.
Subsequently patients enrolling in the extension phase received an intravitreal injection of 0.3 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations.
In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.70 years.
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Ranibizumab was administered by intravitreal injection in the study eye.
Intravitreal injection was performed by the investigator following slitlamp examination.
Other Names:
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Experimental: Group A: Ranibizumab 0.5 mg
In the single dose phase, all patients randomized in Group A received a single intravitreal injection of 0.5 mg of ranibizumab into the study eye.
Those patients who successfully completed this phase entered the multiple dose phase, where they received an intravitreal injection of 0.5 mg of ranibizumab once a month for an additional 11 months.
Subsequently Group A patients enrolling in the extension phase received an intravitreal injection of 0.5 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations.
In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.93 years.
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Ranibizumab was administered by intravitreal injection in the study eye.
Intravitreal injection was performed by the investigator following slitlamp examination.
Other Names:
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Experimental: Group B: Ranibizumab 0.3 mg
Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study.
Group B patients who enrolled in the extension phase received an intravitreal injection of 0.3 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations.
In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.45 years.
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Ranibizumab was administered by intravitreal injection in the study eye.
Intravitreal injection was performed by the investigator following slitlamp examination.
Other Names:
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Experimental: Group B: Ranibizumab 0.5 mg
Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study.
Group B patients who enrolled in the extension phase received an intravitreal injection of 0.5 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations.
In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.36 years.
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Ranibizumab was administered by intravitreal injection in the study eye.
Intravitreal injection was performed by the investigator following slitlamp examination.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change From Baseline in the Best Corrected Visual Acuity Score of the Study Eye at Month 6 in Group B
Time Frame: Baseline and Month 6
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The efficacy assessment was based on Group B patients.
Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 2 meters.
VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a starting test distance of 2 meters.
The BCVA score is the number of letters read correctly by the patient, hence an increase in score indicates improvement in acuity.
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Baseline and Month 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Mean Change From Baseline in the Best Corrected Visual Acuity Score of the Study Eye at Month 12 in Group B
Time Frame: Baseline and Month 12
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The efficacy assessment was based on Group B patients.
BCVA was assessed during all study visits using best correction determined from protocol refraction and ETDRS-like visual acuity testing charts at a starting test distance of 2 meters.
The BCVA score is the number of letters read correctly by the patient, hence an increase in score indicates improvement in acuity.
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Baseline and Month 12
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Categorical Analysis of Best Corrected Visual Acuity of the Study Eye at Month 6 and Month 12 in Group B
Time Frame: Baseline, Month 6 and Month 12
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BCVA measurements were taken in a sitting position using best correction determined from protocol refraction and ETDRS-like visual acuity testing charts at a starting test distance of 2 meters.
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Baseline, Month 6 and Month 12
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Extension Phase: Mean Change From Month 12 (Start of Extension Phase) in Best Corrected Visual Acuity Score of the Study Eye at Last Visit of Extension Phase in Group B.
Time Frame: Month 12 (start of extension phase) and last visit of extension phase. Duration in the extension phase varied depending on the study entry. The mean duration of treatment was 1.45 years in the 0.3 mg group and 1.36 years in the 0.5 mg dose group.
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Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 2 meters.
VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a starting test distance of 2 meters.
The BCVA score is the number of letters read correctly by the patient, hence an increase in score indicates improvement in acuity.
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Month 12 (start of extension phase) and last visit of extension phase. Duration in the extension phase varied depending on the study entry. The mean duration of treatment was 1.45 years in the 0.3 mg group and 1.36 years in the 0.5 mg dose group.
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Extension Phase: Categorical Analysis of Best Corrected Visual Acuity of the Study Eye at Last Visit of Extension Phase in Group B
Time Frame: Baseline and last visit of extension phase - Duration in the extension phase varied depending on the study entry. The mean duration of treatment was 1.45 years in the 0.3 mg group and 1.36 years in the 0.5 mg dose group.
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BCVA measurements were taken in a sitting position using best correction determined from protocol refraction and ETDRS-like visual acuity testing charts at a starting test distance of 2 meters. The following categories were evaluated:
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Baseline and last visit of extension phase - Duration in the extension phase varied depending on the study entry. The mean duration of treatment was 1.45 years in the 0.3 mg group and 1.36 years in the 0.5 mg dose group.
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Mean Change From Baseline in Total Area of Choroidal Neovascularization of the Study Eye in Group B
Time Frame: Baseline, Months 3, 6, 9 and 12
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Choroidal Neovascularization was assessed by fluorescein angiography in conjunction with color fundus photography.
Analysis was performed by the central reading center.
The area of Choroidal Neovascularization is expressed as Macular Photocoagulation Study standard Disc Areas (DA; equivalent to 2.54 mm^2 on the retina).
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Baseline, Months 3, 6, 9 and 12
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Mean Change From Baseline in Total Area of Leakage From CNV Plus Staining of Retinal Pigment Epithelium of the Study Eye in Group B
Time Frame: Baseline, Months 3, 6, 9 and 12
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Area of leakage from CNV plus staining of retinal pigment epithelium was assessed by fluorescein angiography in conjunction with color fundus photography.
Analysis was performed by the central reading center.
The total area is expressed as Macular Photocoagulation Study standard Disc Areas (DA; equivalent to 2.54 mm^2 on the retina).
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Baseline, Months 3, 6, 9 and 12
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Percentage of Participants in Group B With Absence of Leakage in the Study Eye at Month 3, 6, 9 and 12.
Time Frame: Months 3, 6, 9 and 12
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Area of leakage was assessed by fluorescein angiography in conjunction with color fundus photography.
Analysis was performed at the central reading center.
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Months 3, 6, 9 and 12
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Mean Change From Baseline in Foveal Retinal Thickness of the Study Eye in Group B
Time Frame: Baseline, Months 3, 6, 9 and 12
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Foveal retinal thickness was assessed by Optical Coherence Tomography (OCT) at a subset of the study sites and was analyzed by the central reading center.
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Baseline, Months 3, 6, 9 and 12
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Mean Change From Baseline in Total Retinal Volume of the Study Eye in Group B
Time Frame: Baseline, Months 3, 6, 9 and 12
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Total retinal volume was assessed by Optical Coherence tomography (OCT) at a subset of the study sites and was analyzed by the central reading center.
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Baseline, Months 3, 6, 9 and 12
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Tano Y, Ohji M; EXTEND-I Study Group. EXTEND-I: safety and efficacy of ranibizumab in Japanese patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration. Acta Ophthalmol. 2010 May;88(3):309-16. doi: 10.1111/j.1755-3768.2009.01843.x. Epub 2010 Feb 16.
- Tano Y, Ohji M; EXTEND-I Study Group. Long-term efficacy and safety of ranibizumab administered pro re nata in Japanese patients with neovascular age-related macular degeneration in the EXTEND-I study. Acta Ophthalmol. 2011 May;89(3):208-17. doi: 10.1111/j.1755-3768.2010.02065.x. Epub 2011 Jan 14.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Eye Diseases
- Retinal Degeneration
- Retinal Diseases
- Uveal Diseases
- Neoplastic Processes
- Choroid Diseases
- Metaplasia
- Macular Degeneration
- Neoplasm Metastasis
- Choroidal Neovascularization
- Neovascularization, Pathologic
- Physiological Effects of Drugs
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Ranibizumab
Other Study ID Numbers
- CRFB002A1201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Subfoveal Choroidal Neovascularization(CNV) Secondary to Age-related Macular Degeneration (AMD)
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NovartisCompletedSubfoveal Choroidal Neovascularization (CNV) | Secondary to Age-related Macular Degeneration (AMD)Germany, Belgium, Spain, Netherlands, United Kingdom, Hungary, Turkey, Israel, Portugal, Australia
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Novartis PharmaceuticalsCompletedSubfoveal Choroidal Neovascularization CNV Secondary to Wet Age-related Macular Degeneration AMDAustralia
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PfizerTerminatedAge-related Macular Degeneration (AMD) | Choroidal Neovascularization (CNV) | Early MarkersItaly, Portugal, United Kingdom
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PfizerTerminatedMacular Degeneration | Age Related Macular Degeneration (AMD) | Choroidal Neovascularization (CNV)Canada, Belgium, United Kingdom, France, Poland, Spain, Turkey, Czech Republic, Italy, Greece, Germany, Austria, Portugal, Denmark, Finland
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Johns Hopkins UniversityCompletedAge-related Macular Degeneration | Choroidal Neovascularization | CNV | AMD | Combretastatin A4 PhosphateUnited States
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AllerganTerminatedAge-Related Maculopathy | Subfoveal Choroidal NeovascularizationUnited States
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Poitiers University HospitalTerminatedAge-related Macular Degeneration | AMD | Choroidal NeovascularisationFrance
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RXi Pharmaceuticals, Corp.UnknownAge-related Macular Degeneration | Subfoveal Choroidal Neovascularization | Subretinal Scarring | Subretinal FibrosisUnited States
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AbbVieRecruitingCNV | AMD | nAMD | Wet AMD | Wet Age-related Macular Degeneration | wAMDUnited States
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David M. Brown, M.D.Genentech, Inc.TerminatedMacular Degeneration | Age Related Macular Degeneration | Wet Age-Related Macular Degeneration | Choroidal Neovascular Membrane | Subfoveal Neovascular Age-Related Macular DegenerationUnited States
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