A Safety and Efficacy Study of E10030 (Anti-PDGF Pegylated Aptamer) Plus Lucentis for Neovascular Age-Related Macular Degeneration

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Age-Related Macular Degeneration

Intervention / Treatment
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* Drug: E10030 plus Lucentis
* Drug: Lucentis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lucentis<br> | Drug: Lucentis<br>* 10 mg/mL intravitreal injection monthly<br>|
| Experimental: E10030 low dose plus Lucentis<br> | Drug: E10030 plus Lucentis<br>* once a month intravitreal injection<br>|
| Experimental: E10030 high dose plus Lucentis<br> | Drug: E10030 plus Lucentis<br>* once a month intravitreal injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Visual Acuity From Baseline at the Week 24 Visit | The primary efficacy endpoint is the mean change in visual acuity from baseline at the Week 24 visit | 24 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Proportion of Subjects Gaining 15 or More ETDRS Letters From Baseline at the Week 24 Visit | The proportion of subjects gaining 15 or more ETDRS letters from baseline at the Week 24 visit | 24 weeks | 
| Proportion of Patients With at Least 1 Adverse Event |  | 24 weeks |