Clinical trial NCT00331864: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Age Related Macular Degeneration
Choroidal Neovascularization
Keywords: AMD, ranibizumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-05-31
Enrollment: 531
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Percentage of Patients With Ocular Adverse Events (AEs) in the Study Eye
timeFrame: Baseline through end of study (12 month treatment period)
measure: Percentage of Patients With Targeted Grade 3 Adverse Events (AEs) in the Study Eye
timeFrame: Baseline through end of study (12 month treatment period)
Secondary outcomes:
measure: Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 3
timeFrame: Baseline and Month 3
measure: Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 12
timeFrame: Baseline and Month 12
measure: Mean Change in Central Retinal Thickness of the Study Eye From Baseline to Month 3
timeFrame: Baseline and Month 3
measure: Mean Change in Central Retinal Thickness of the Study Eye From Baseline to Month 12
timeFrame: Baseline and Month 12
measure: Time to the First Retreatment After Month 2
timeFrame: Month 2 to Month 11
measure: Total Number of Treatments
timeFrame: Baseline (Month 0) to Month 11
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis - 64 sites in 11 countries
Study officials:
affiliation: Novartis - Including Sites in Germany
name: Novartis Customer Information
role: STUDY_CHAIR
References: