NCT01089517

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
449

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 18, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

January 3, 2014

Completed
Last Updated

March 19, 2024

Status Verified

April 1, 2017

Enrollment Period

2.3 years

First QC Date

March 12, 2010

Results QC Date

November 13, 2013

Last Update Submit

February 20, 2024

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

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

    24 weeks

  • Proportion of Patients With at Least 1 Adverse Event

    24 weeks

Study Arms (3)

Lucentis

ACTIVE COMPARATOR
Drug: Lucentis

E10030 low dose plus Lucentis

EXPERIMENTAL
Drug: E10030 plus Lucentis

E10030 high dose plus Lucentis

EXPERIMENTAL
Drug: E10030 plus Lucentis

Interventions

E10030 plus LucentisDRUG

once a month intravitreal injection

E10030 high dose plus LucentisE10030 low dose plus Lucentis
LucentisDRUG

10 mg/mL intravitreal injection monthly

Lucentis

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subfoveal choroidal neovascularization (CNV) due to AMD

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Palmetto Retinal Center

West Columbia, South Carolina, 29169, United States

Location

Related Publications (1)

  • 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.

    PMID: 30957581DERIVED

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Jeffrey Nau
Organization
Ophthotech
jeff.nau@ophthotech.com
646-573-7045

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2010

First Posted

March 18, 2010

Study Start

March 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

March 19, 2024

Results First Posted

January 3, 2014

Record last verified: 2017-04

Locations

US(1)