A Phase 1, Safety, Tolerability and Pharmacokinetic Profile of Intravitreous Injections of E10030 (Anti-PDGF Pegylated Aptamer) in Subjects With Neovascular Age-Related Macular Degeneration

Phase 1

Completed

• Conditions: Age-related Macular Degeneration
• Interventions: Drug: E10030

• Registration Number: NCT00569140
• Lead Sponsor: Ophthotech Corporation

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-04
• Study First Submitted QC: 2007-12-05
• Study First Posted: 2007-12-06
• Study Completion: 2008-12
• Status Verified: 2010-01
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Subfoveal choroidal neovascularization (CNV) due to AMD

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	E10030	E10030

Primary Outcome Measures

Name	Time	Method
Ophthalmic DLTs	immediate

Secondary Outcome Measures

Name	Time	Method
adverse events	immendiate

Trial Locations

Locations (1)

Denise Teuber; 🇺🇸 New York, New York, United States