NCT00569140

Brief Summary

The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic profile of E10030 intravitreous injection when administered as monotherapy or in combination with Lucentis® 0.5 mg/eye 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
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2007

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

December 1, 2007

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 6, 2007

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

February 21, 2024

Status Verified

January 1, 2010

First QC Date

December 4, 2007

Last Update Submit

February 20, 2024

Conditions

Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • Ophthalmic DLTs

    immediate

Secondary Outcomes (1)

  • adverse events

    immendiate

Study Arms (1)

1

NO INTERVENTION

E10030

Drug: E10030

Interventions

E10030DRUG

Intravitreal injection

1

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:
  • Diabetic retinopathy.
  • 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 revascularization with 6 months, ventricular tachyarrythmias requiring ongoing treatment.
  • History or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation.
  • Clinically significant impaired renal (serum creatinine \>2.5 mg/dl or s/p renal transplant or receiving dialysis) or hepatic function.
  • Stroke (within 12 months of trial entry).
  • Any major surgical procedure within one month of trial entry. Previous therapeutic radiation in the region of the study eye. Any treatment with an investigational agent in the past 60 days for any condition.
  • Known serious allergies to the fluorescein dye used in angiography, to the components of the ranibizumab formulation, or to the components of the E10030 formulation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Denise Teuber

New York, New York, 10119, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

E10030 aptamer

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 4, 2007

First Posted

December 6, 2007

Study Start

December 1, 2007

Study Completion

December 1, 2008

Last Updated

February 21, 2024

Record last verified: 2010-01

Locations

US(1)