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

Last updated: February 20, 2024
Sponsor: Ophthotech Corporation
Overall Status: Completed

Phase

1

Condition

Aging

Myopic Macular Degeneration

Macular Degeneration

Treatment

E10030

Clinical Study ID

NCT00569140
OPH 1000
  • Ages 50-100
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria: Subfoveal choroidal neovascularization (CNV) due to AMD

Exclusion

Exclusion Criteria:

  • Any of the following underlying diseases including:
  • Diabetic retinopathy.
  • History or evidence of severe cardiac disease (e.g., NYHA Functional Class III orIV - see Appendix 19.6), history or clinical evidence of unstable angina, acutecoronary syndrome, myocardial infarction or revascularization with 6 months,ventricular tachyarrythmias requiring ongoing treatment.
  • History or evidence of clinically significant peripheral vascular disease, suchas intermittent claudication or prior amputation.
  • Clinically significant impaired renal (serum creatinine >2.5 mg/dl or s/p renaltransplant or receiving dialysis) or hepatic function.
  • Stroke (within 12 months of trial entry).
  • Any major surgical procedure within one month of trial entry. Previoustherapeutic radiation in the region of the study eye. Any treatment with aninvestigational agent in the past 60 days for any condition. Known serious allergies to the fluorescein dye used in angiography, to the components ofthe ranibizumab formulation, or to the components of the E10030 formulation.

Study Design

Total Participants: 18
Treatment Group(s): 1
Primary Treatment: E10030
Phase: 1
Study Start date:
December 01, 2007
Estimated Completion Date:
December 31, 2008

Connect with a study center

  • Denise Teuber

    New York, New York 10119
    United States

    Site Not Available

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