Status:
COMPLETED
SUSTAIN - Study of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
Lead Sponsor:
Novartis
Conditions:
Age Related Macular Degeneration
Choroidal Neovascularization
Eligibility:
All Genders
50+ years
Phase:
PHASE3
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 administe...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
531 Patients enrolled
Trial Details
Trial ID
NCT00331864
Start Date
April 1 2006
End Date
April 1 2008
Last Update
February 18 2011
Active Locations (1)
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1
Novartis - 64 sites in 11 countries
Basel, Switzerland