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

Primary Purpose

Age-Related Macular Degeneration

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

E10030 plus Lucentis

Lucentis

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Palmetto Retinal Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Lucentis

E10030 low dose plus Lucentis

E10030 high dose plus Lucentis

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Proportion of Patients With at Least 1 Adverse Event

Full Information

NCT ID

NCT01089517

First Posted

March 12, 2010

Last Updated

April 6, 2017

Sponsor

Ophthotech Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01089517

Brief Title

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

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ophthotech Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Age-Related Macular Degeneration

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

449 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lucentis

Arm Type

Active Comparator

Arm Title

E10030 low dose plus Lucentis

Arm Type

Experimental

Arm Title

E10030 high dose plus Lucentis

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

E10030 plus Lucentis

Intervention Description

once a month intravitreal injection

Intervention Type

Drug

Intervention Name(s)

Lucentis

Intervention Description

10 mg/mL intravitreal injection monthly

Primary Outcome Measure Information:

Title

Mean Change in Visual Acuity From Baseline at the Week 24 Visit

Description

The primary efficacy endpoint is the mean change in visual acuity from baseline at the Week 24 visit

Time Frame

24 Weeks

Secondary Outcome Measure Information:

Title

The Proportion of Subjects Gaining 15 or More ETDRS Letters From Baseline at the Week 24 Visit

Description

The proportion of subjects gaining 15 or more ETDRS letters from baseline at the Week 24 visit

Time Frame

24 weeks

Title

Proportion of Patients With at Least 1 Adverse Event

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Palmetto Retinal Center

City

West Columbia

State/Province

South Carolina

ZIP/Postal Code

29169

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

30957581

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.

Results Reference

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

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