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

This study has been completed.
Sponsor:
Information provided by:
Ophthotech Corporation
ClinicalTrials.gov Identifier:
NCT00569140
First received: December 4, 2007
Last updated: January 21, 2010
Last verified: January 2010
  Purpose

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).


Condition Intervention Phase
Age-Related Macular Degeneration
Drug: E10030
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Single Ascending Dose Trial to Establish the Safety, Tolerability and Pharmacokinetic Profile of Intravitreous Injections of E10030 (Anti-PDGF Pegylated Aptamer) Monotherapy and of E10030 Given in Combination With Lucentis®0.5 Mg/Eye in Subjects With Neovascular Age-Related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Ophthotech Corporation:

Primary Outcome Measures:
  • Ophthalmic DLTs [ Time Frame: immediate ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • adverse events [ Time Frame: immendiate ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 18
Study Start Date: December 2007
Study Completion Date: December 2008
Arms Assigned Interventions
No Intervention: 1
E10030
Drug: E10030
Intravitreal injection

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00569140

Locations
United States, New York
Denise Teuber
New York, New York, United States, 10119
Sponsors and Collaborators
Ophthotech Corporation
  More Information

No publications provided

Responsible Party: Denise Teuber, Ophthotech Corp
ClinicalTrials.gov Identifier: NCT00569140     History of Changes
Other Study ID Numbers: OPH 1000
Study First Received: December 4, 2007
Last Updated: January 21, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 20, 2014