A Phase 2, Randomized, Double-Masked, Controlled Trial to Establish the Safety and Efficacy of Intravitreous Injections of E10030 (Anti-PDGF Pegylated Aptamer) Given in Combination With Lucentis in Subjects With Neovascular Age-Related Macular Degeneration
Overview
- Phase
- Phase 2
- Intervention
- Lucentis
- Conditions
- Age-Related Macular Degeneration
- Sponsor
- Ophthotech Corporation
- Enrollment
- 449
- Locations
- 1
- Primary Endpoint
- Mean Change in Visual Acuity From Baseline at the Week 24 Visit
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The objectives of this study are to evaluate the safety and efficacy of E10030 intravitreous injection when administered in combination with Lucentis® against a control of Lucentis® alone in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).
Detailed Description
Subjects will be randomized in a 1:1:1 ratio to the following dose groups: * E10030 0.3 mg/eye + Lucentis® 0. 5 mg/eye * E10030 1.5 mg/eye + Lucentis® 0. 5 mg/eye * E10030 sham + Lucentis® 0. 5 mg/eye Subjects will be treated with active E10030 or sham E10030 in combination with Lucentis® at Day 0, Week 4, Week 8, Week 12, Week 16 and Week 20. Primary Efficacy Endpoint: The primary efficacy endpoint is mean change in visual acuity from baseline at the Week 24 visit Safety Endpoints: Safety endpoints include adverse events, vital signs, ophthalmic variables \[visual acuity, intraocular pressure (IOP), ophthalmic examination, color fundus photography, fluorescein angiograms (FA), optical coherence tomography (OCT)\], and laboratory variables. Approximately 444 subjects will be randomized into one of the three treatment cohorts (approximately 148 patients per dose group).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subfoveal choroidal neovascularization (CNV) due to AMD
Exclusion Criteria
- •Any of the following underlying diseases including:
- •Diabetes mellitus
- •History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV - see Appendix 19.6), history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or coronary artery revascularization within 6 months, or ventricular tachyarrhythmias requiring ongoing treatment.
- •Clinically significant impaired renal or hepatic function.
- •Stroke (within 12 months of trial entry).
- •Any major surgical procedure within one month of trial entry.
- •Known serious allergies to the fluorescein dye used in angiography (mild allergy amenable to treatment is allowable), to the components of the ranibizumab (Lucentis) formulation, or to the components of the E10030 formulation
Arms & Interventions
Lucentis
Intervention: Lucentis
E10030 low dose plus Lucentis
Intervention: E10030 plus Lucentis
E10030 high dose plus Lucentis
Intervention: E10030 plus Lucentis
Outcomes
Primary Outcomes
Mean Change in Visual Acuity From Baseline at the Week 24 Visit
Time Frame: 24 Weeks
The primary efficacy endpoint is the mean change in visual acuity from baseline at the Week 24 visit
Secondary Outcomes
- Proportion of Patients With at Least 1 Adverse Event(24 weeks)
- The Proportion of Subjects Gaining 15 or More ETDRS Letters From Baseline at the Week 24 Visit(24 weeks)