Phase 2 N=449 Randomized Quadruple-blind Treatment

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

Age-Related Macular Degeneration

Bottom Line

View on ClinicalTrials.gov: NCT01089517 ↗

Enrolled (actual)

449

Serious AEs

8.0%

Results posted

Jan 2014

Primary outcome: Primary: Mean Change in Visual Acuity From Baseline at the Week 24 Visit — 6.5; 8.8; 10.6 ETDRS Letters

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: E10030 plus Lucentis (Drug); Lucentis (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Ophthotech Corporation
Primary completion: Jun 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change in Visual Acuity From Baseline at the Week 24 Visit	6.5; 8.8; 10.6	—
SECONDARY The Proportion of Subjects Gaining 15 or More ETDRS Letters From Baseline at the Week 24 Visit	34.0; 33.3; 39.1	—
SECONDARY Proportion of Patients With at Least 1 Adverse Event	65.5; 67.1; 65.1	—

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).

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01089517). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.