Back to resultsSUSTAIN - Study of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
Primary Purpose
Age Related Macular Degeneration, Choroidal Neovascularization
Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Ranibizumab
Sponsored by
About this trial
This is an interventional treatment trial for Age Related Macular Degeneration focused on measuring AMD, ranibizumab
Eligibility Criteria
Patients who participated in this study included those who had completed participation in the study CRFB002A2301 (ANCHOR; NCT00061594), newly diagnosed patients, as well as previously diagnosed patients who had had recent disease progression. Inclusion Criteria: Male or female patients > 50 years of age Diagnosis of active primary or recurrent CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component The total area of CNV (including both classic and occult components) encompassed within the lesion must be >= 50% of the total lesion area The total lesion area must be <= 12 disc areas Patients who have a BCVA (best corrected visual acuity) score between 73 and 24 letters, inclusive, in the study eye using ETDRS-like (Early Treatment of Diabetic Retinopathy Study) grading charts (approximately 20/40 to 20/320) Exclusion Criteria: Patients who have a BCVA of < 34 letters in both eyes (legally blind is defined as bilateral vision below 20/200 or less than 34 letters) Laser photocoagulation, treatment with intravitreal steroids, verteporfin photo dynamic therapy or pegaptanib sodium in the study eye within 30 days preceding Day 1 Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.) Other protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
- Novartis - 64 sites in 11 countries
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ranibizumab
Arm Description
Ranibizumab-naïve (Non-ANCHOR) patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on re-treatment criteria described in the protocol. For patients who had participated in the ANCHOR study, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met re-treatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
Outcomes
Primary Outcome Measures
Percentage of Patients With Ocular Adverse Events (AEs) in the Study Eye
Percentage of patients with ocular adverse events in the study eye over the one year (12 month) treatment period.
Percentage of Patients With Targeted Grade 3 Adverse Events (AEs) in the Study Eye
Grade 3 targeted AEs included:
4+ ocular inflammation or 2-3+ ocular inflammation failing to decrease to ≤ 1+ within 30 days
≥ 30 letter decrease in BCVA that developed within 14 days of ranibizumab injection
sustained (>15 minutes) loss of light perception due to elevated intraocular pressure (IOP) or a >20 mm Hg change in IOP persisting longer than 14 days
new retinal tear or detachment involving the macula
new vitreous hemorrhage >2+ severity not resolving within 14 days
new or increase of previous retinal hemorrhage >1 disc area in size and involving the fovea
Secondary Outcome Measures
Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 3
BCVA was assessed using best correction determined from protocol refraction. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at an initial testing distance of 4 meters.
BCVA is measured by the number of letters a patient could correctly read on an eye chart; hence an increased score indicates improvement in acuity.
Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 12
BCVA was assessed using best correction determined from protocol refraction. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at an initial testing distance of 4 meters.
BCVA is measured by the number of letters a patient could correctly read on an eye chart; hence an increased score indicates improvement in acuity.
Mean Change in Central Retinal Thickness of the Study Eye From Baseline to Month 3
Central retinal thickness was assessed using optical coherence tomography (OCT). OCT imaging was performed by trained personnel at each site using the Zeiss Stratus OCT™ 3 with version A6.1 (or more recent) software. Analysis of the OCT images was performed by the investigator. A negative number indicates improvement (reduced thickness).
Mean Change in Central Retinal Thickness of the Study Eye From Baseline to Month 12
Central retinal thickness was assessed using optical coherence tomography (OCT). OCT imaging was performed by trained personnel at each site using the Zeiss Stratus OCT™ 3 with version A6.1 (or more recent) software. Analysis of the OCT images was performed by the investigator. A negative number indicates improvement (reduced thickness).
Time to the First Retreatment After Month 2
Time to first re-treatment is calculated as time difference in months starting from Month 2 until the month of first re-treatment.
Criteria for re-treatment:
a >5 letter decrease in BCVA (determined using EDRS charts) based upon the highest visual acuity score from any prior scheduled study visit (Months 0, 1, 2 or 3)
a >100 µm increase in central retinal thickness (determined using OCT) from the thinnest measurement from any prior scheduled study visit (Months 0, 1, 2 or 3)
Total Number of Treatments
Total number of treatments administered during the entire treatment period (Month 0 to 11).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00331864
Brief Title
SUSTAIN - Study of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
Official Title
A Phase IIIb, Open-label, Multi-center 12 Month Study to Evaluate the Safety, Tolerability and Efficacy of Ranibizumab (0.3 mg and/or 0.5 mg) in Patients With Subfoveal Choroidal Neovasculariza-tion Secondary to Age-related Macular Degeneration
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
Ranibizumab is a humanised recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A. This study will assess the safety and efficacy of ranibizumab administered on an as-needed dosing regimen in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration, Choroidal Neovascularization
Keywords
AMD, ranibizumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
531 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ranibizumab
Arm Type
Experimental
Arm Description
Ranibizumab-naïve (Non-ANCHOR) patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on re-treatment criteria described in the protocol. For patients who had participated in the ANCHOR study, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met re-treatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
rhuFab V2
Primary Outcome Measure Information:
Title
Percentage of Patients With Ocular Adverse Events (AEs) in the Study Eye
Description
Percentage of patients with ocular adverse events in the study eye over the one year (12 month) treatment period.
Time Frame
Baseline through end of study (12 month treatment period)
Title
Percentage of Patients With Targeted Grade 3 Adverse Events (AEs) in the Study Eye
Description
Grade 3 targeted AEs included:
4+ ocular inflammation or 2-3+ ocular inflammation failing to decrease to ≤ 1+ within 30 days
≥ 30 letter decrease in BCVA that developed within 14 days of ranibizumab injection
sustained (>15 minutes) loss of light perception due to elevated intraocular pressure (IOP) or a >20 mm Hg change in IOP persisting longer than 14 days
new retinal tear or detachment involving the macula
new vitreous hemorrhage >2+ severity not resolving within 14 days
new or increase of previous retinal hemorrhage >1 disc area in size and involving the fovea
Time Frame
Baseline through end of study (12 month treatment period)
Secondary Outcome Measure Information:
Title
Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 3
Description
BCVA was assessed using best correction determined from protocol refraction. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at an initial testing distance of 4 meters.
BCVA is measured by the number of letters a patient could correctly read on an eye chart; hence an increased score indicates improvement in acuity.
Time Frame
Baseline and Month 3
Title
Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 12
Description
BCVA was assessed using best correction determined from protocol refraction. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at an initial testing distance of 4 meters.
BCVA is measured by the number of letters a patient could correctly read on an eye chart; hence an increased score indicates improvement in acuity.
Time Frame
Baseline and Month 12
Title
Mean Change in Central Retinal Thickness of the Study Eye From Baseline to Month 3
Description
Central retinal thickness was assessed using optical coherence tomography (OCT). OCT imaging was performed by trained personnel at each site using the Zeiss Stratus OCT™ 3 with version A6.1 (or more recent) software. Analysis of the OCT images was performed by the investigator. A negative number indicates improvement (reduced thickness).
Time Frame
Baseline and Month 3
Title
Mean Change in Central Retinal Thickness of the Study Eye From Baseline to Month 12
Description
Central retinal thickness was assessed using optical coherence tomography (OCT). OCT imaging was performed by trained personnel at each site using the Zeiss Stratus OCT™ 3 with version A6.1 (or more recent) software. Analysis of the OCT images was performed by the investigator. A negative number indicates improvement (reduced thickness).
Time Frame
Baseline and Month 12
Title
Time to the First Retreatment After Month 2
Description
Time to first re-treatment is calculated as time difference in months starting from Month 2 until the month of first re-treatment.
Criteria for re-treatment:
a >5 letter decrease in BCVA (determined using EDRS charts) based upon the highest visual acuity score from any prior scheduled study visit (Months 0, 1, 2 or 3)
a >100 µm increase in central retinal thickness (determined using OCT) from the thinnest measurement from any prior scheduled study visit (Months 0, 1, 2 or 3)
Time Frame
Month 2 to Month 11
Title
Total Number of Treatments
Description
Total number of treatments administered during the entire treatment period (Month 0 to 11).
Time Frame
Baseline (Month 0) to Month 11
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients who participated in this study included those who had completed participation in the study CRFB002A2301 (ANCHOR; NCT00061594), newly diagnosed patients, as well as previously diagnosed patients who had had recent disease progression.
Inclusion Criteria:
Male or female patients > 50 years of age
Diagnosis of active primary or recurrent CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component
The total area of CNV (including both classic and occult components) encompassed within the lesion must be >= 50% of the total lesion area
The total lesion area must be <= 12 disc areas
Patients who have a BCVA (best corrected visual acuity) score between 73 and 24 letters, inclusive, in the study eye using ETDRS-like (Early Treatment of Diabetic Retinopathy Study) grading charts (approximately 20/40 to 20/320)
Exclusion Criteria:
Patients who have a BCVA of < 34 letters in both eyes (legally blind is defined as bilateral vision below 20/200 or less than 34 letters)
Laser photocoagulation, treatment with intravitreal steroids, verteporfin photo dynamic therapy or pegaptanib sodium in the study eye within 30 days preceding Day 1
Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)
Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Customer Information
Organizational Affiliation
Novartis - Including Sites in Germany
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis - 64 sites in 11 countries
City
Basel
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
SUSTAIN - Study of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
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