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

Age Related Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00331864
• Other study ID #: CRFB002A2303
• Status: Completed
• Phase: Phase 3
• First received: April 11, 2006
• Last updated: February 15, 2011
• Start date: April 2006
• Est. completion date: April 2008

Study information

• Verified date: February 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 531
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic

Intervention

Drug:
• Ranibizumab

Locations

Country	Name	City	State
Switzerland	Novartis - 64 sites in 11 countries	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Primary	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)	Yes
Secondary	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.	Baseline and Month 3	No
Secondary	Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 12	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.	Baseline and Month 12	No
Secondary	Mean Change in Central Retinal Thickness of the Study Eye From Baseline to Month 3	Central retinal thickness was assessed using optical coherence tomography (OCT). OCT imaging was performed by trained personnel at each site using the Zeiss Stratus OCT™ 3 with version A6.1 (or more recent) software. Analysis of the OCT images was performed by the investigator. A negative number indicates improvement (reduced thickness).	Baseline and Month 3	No
Secondary	Mean Change in Central Retinal Thickness of the Study Eye From Baseline to Month 12	Central retinal thickness was assessed using optical coherence tomography (OCT). OCT imaging was performed by trained personnel at each site using the Zeiss Stratus OCT™ 3 with version A6.1 (or more recent) software. Analysis of the OCT images was performed by the investigator. A negative number indicates improvement (reduced thickness).	Baseline and Month 12	No
Secondary	Time to the First Retreatment After Month 2	Time to first re-treatment is calculated as time difference in months starting from Month 2 until the month of first re-treatment.; Criteria for re-treatment: a >5 letter decrease in BCVA (determined using EDRS charts) based upon the highest visual acuity score from any prior scheduled study visit (Months 0, 1, 2 or 3); a >100 µm increase in central retinal thickness (determined using OCT) from the thinnest measurement from any prior scheduled study visit (Months 0, 1, 2 or 3)	Month 2 to Month 11	No
Secondary	Total Number of Treatments	Total number of treatments administered during the entire treatment period (Month 0 to 11).	Baseline (Month 0) to Month 11	Yes