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

NCT00331864 | Completed Phase 3 Results

• 1 other identifier: CRFB002A2303
• Study Type: interventional
• Target: 531
• Locations: 1 country
• Sites: 1

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).

Conditions

Age Related Macular Degeneration; Choroidal Neovascularization

Keywords

AMD, ranibizumab

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Baseline through end of study (12 month treatment period)

Secondary Outcomes (6)

• Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 3

  Baseline and Month 3

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

  Baseline and Month 12

• Mean Change in Central Retinal Thickness of the Study Eye From Baseline to Month 3

  Baseline and Month 3

• Mean Change in Central Retinal Thickness of the Study Eye From Baseline to Month 12

  Baseline and Month 12

• Time to the First Retreatment After Month 2

  Month 2 to Month 11

Study Arms (1)

Ranibizumab

EXPERIMENTAL

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.

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

Also known as: rhuFab V2

Ranibizumab

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis - 64 sites in 11 countries

Basel, Switzerland

Location

MeSH Terms

Conditions

Macular Degeneration; Choroidal Neovascularization

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Customer Information

  Novartis - Including Sites in Germany

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 11, 2006
• First Posted: May 31, 2006
• Study Start: April 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: February 18, 2011
• Results First Posted: January 4, 2011

Record last verified: 2011-02

Locations

CH (1)