Clinical trial NCT01089517: A Safety and Efficacy Study of E10030 (Anti-PDGF Pegylated Aptamer) Plus Lucentis for Neovascular Age-Related Macular Degeneration
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Age-Related Macular Degeneration
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2010-03-18
Enrollment: 449
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Mean Change in Visual Acuity From Baseline at the Week 24 Visit
timeFrame: 24 Weeks
Secondary outcomes:
measure: The Proportion of Subjects Gaining 15 or More ETDRS Letters From Baseline at the Week 24 Visit
timeFrame: 24 weeks
measure: Proportion of Patients With at Least 1 Adverse Event
timeFrame: 24 weeks
Other outcomes:
Locations:
city: West Columbia
country: United States
facility: Palmetto Retinal Center
state: South Carolina
Study officials:
References:
citation: Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.