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

NCT ID: NCT01089517

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 449 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2012-06-30

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).

Conditions

Age-Related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lucentis

Group Type: ACTIVE_COMPARATOR

Lucentis

Intervention Type: DRUG

10 mg/mL intravitreal injection monthly

E10030 low dose plus Lucentis

Group Type: EXPERIMENTAL

E10030 plus Lucentis

Intervention Type: DRUG

once a month intravitreal injection

E10030 high dose plus Lucentis

Group Type: EXPERIMENTAL

E10030 plus Lucentis

Intervention Type: DRUG

once a month intravitreal injection

Interventions

E10030 plus Lucentis

once a month intravitreal injection

Intervention Type: DRUG

Lucentis

10 mg/mL intravitreal injection monthly

Intervention Type: DRUG

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ophthotech Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Palmetto Retinal Center

West Columbia, South Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30957581 (View on PubMed)

Other Identifiers

OPH1001

Identifier Type: -

Identifier Source: org_study_id