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

Ophthotech

Status and phase

Completed

Phase 2

Conditions

Age-Related Macular Degeneration

Treatments

Drug: E10030 plus Lucentis

Drug: Lucentis

Study type

Interventional

Funder types

Industry

Identifiers

NCT01089517

OPH1001

Details and patient eligibility

About

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).

Full 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).

Enrollment

449 patients

Sex

All

Ages

50 to 100 years old

Volunteers

No Healthy Volunteers

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