Phase 3
N=531
SUSTAIN - Study of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
Age Related Macular Degeneration · Choroidal Neovascularization
Bottom Line
View on ClinicalTrials.gov: NCT00331864 ↗Enrolled (actual)
531
Serious AEs
15.8%
Results posted
Jan 2011
Primary outcome: Primary: Percentage of Patients With Ocular Adverse Events (AEs) in the Study Eye — 48.5; 38.9 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ranibizumab (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Ocular Adverse Events (AEs) in the Study Eye |
48.5; 38.9 | — |
| PRIMARY Percentage of Patients With Targeted Grade 3 Adverse Events (AEs) in the Study Eye |
2.9; 0.0 | — |
| SECONDARY Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 3 |
56.2; 47.2; 5.8; 1.9 | — |
| SECONDARY Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 12 |
56.2; 47.2; 3.6; 1.6 | — |
| SECONDARY Mean Change in Central Retinal Thickness of the Study Eye From Baseline to Month 3 |
339.6; 214.1; -101.1; 36.3 | — |
| SECONDARY Mean Change in Central Retinal Thickness of the Study Eye From Baseline to Month 12 |
339.6; 214.1; -91.5; 39.3 | — |
| SECONDARY Time to the First Retreatment After Month 2 |
2 | — |
| SECONDARY Total Number of Treatments |
5.6; 1.1 | — |
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).
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.
Data sourced from ClinicalTrials.gov (NCT00331864). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.