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

Age-Related Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01089517
• Other study ID #: OPH1001
• Status: Completed
• Phase: Phase 2
• Start date: March 2010
• Est. completion date: June 2012

Study information

• Verified date: April 2017
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 449
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• E10030 plus Lucentis
once a month intravitreal injection
• Lucentis
10 mg/mL intravitreal injection monthly

Locations

Country	Name	City	State
United States	Palmetto Retinal Center	West Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Ophthotech Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Proportion of Patients With at Least 1 Adverse Event		24 weeks