SUSTAIN - Study of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration

Novartis531 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

531

Conditions

Interventions

RanibizumabDRUG

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Novartis - 64 sites in 11 countries

Basel, Switzerland

Outcomes

Primary Outcomes

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.

Time frame: Baseline through end of study (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

Time frame: Baseline through end of study (12 month treatment period)

Secondary Outcomes

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.

Time frame: Baseline and Month 3

Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 12

Data from ClinicalTrials.gov

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