A Phase 3, Randomized, Double-masked, Parallel-assignment and Dose-finding Study of Intravitreal Bevasiranib Sodium, Administered Every 8 Weeks as Maintenance Therapy Following Three Injections of Lucentis® Compared With Lucentis® Monotherapy Every 4 Weeks in Patients With Exudative Age-Related Macular Degeneration (AMD).
Overview
- Phase
- Phase 3
- Intervention
- ranibizumab
- Conditions
- Age Related Macular Degeneration
- Sponsor
- OPKO Health, Inc.
- Primary Endpoint
- Primary efficacy measure: The proportion of patients at week 60 in each group with a successful visual acuity outcome (as defined as avoidance of a 3, or more, line loss in vision).
- Status
- Withdrawn
- Last Updated
- 11 years ago
Overview
Brief Summary
The purpose of this study is to compare the safety and effectiveness of three doses of intravitreal bevasiranib sodium as maintenance therapy for Age-Related Macular Degeneration following initiation of anti-VEGF therapy with three doses of Lucentis®.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must be age 50 years or older
- •Patients must have predominantly classic, minimally classic or occult with no classic lesions secondary to Age Related Macular Degeneration.
- •The study eye must have ETDRS best corrected visual acuity of 69 to 24 letters (20/40 to 20/320 Snellen equivalent).
- •Patients must be willing and able to return for scheduled monthly follow-up visits for two-years.
Exclusion Criteria
- •Prior pharmacologic treatment for AMD in the study (patients can not have previously received Avastin®/Lucentis®, Macugen®, or any other anti-VEGF agents, steroid treatments, PDT, radiation treatment, or any experimental therapies for AMD in the study eye)
- •Any intraocular surgery of the study eye within 12 weeks of screening
- •Previous posterior vitrectomy of the study eye
- •Advanced glaucoma or intraocular pressure above 22 mm Hg in the study eye despite treatment.
Arms & Interventions
A
Lucentis® (0.5 mg) every 4 weeks.
Intervention: ranibizumab
B
Bevasiranib (1.0 mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 \& 6.
Intervention: Bevasiranib
C
Bevasiranib (2.0 mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 \& 6.
Intervention: Bevasiranib
D
Bevasiranib (2.5 mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 \& 6.
Intervention: Bevasiranib
Outcomes
Primary Outcomes
Primary efficacy measure: The proportion of patients at week 60 in each group with a successful visual acuity outcome (as defined as avoidance of a 3, or more, line loss in vision).
Time Frame: 60 weeks
Secondary Outcomes
- Time from tx initiation to 1st use of rescue(60 weeks)
- Distribution of change in VA from baseline to 60 weeks(60 weeks)
- Proportion of patients at week 60 with a 3, or more, line gain in vision(60 weeks)