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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00569140
Recruitment Status : Completed
First Posted : December 6, 2007
Last Update Posted : January 25, 2010
Sponsor:
Information provided by:
Ophthotech

Study Description
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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).

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Drug: E10030 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2007
Actual Study Completion Date : December 2008

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Arms and Interventions
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Arm Intervention/treatment
No Intervention: 1
E10030
 Drug: E10030
Intravitreal injection


Outcome Measures
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Primary Outcome Measures :
  1. Ophthalmic DLTs [ Time Frame: immediate ]

Secondary Outcome Measures :
  1. adverse events [ Time Frame: immendiate ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00569140


Locations
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United States, New York
Denise Teuber
New York, New York, United States, 10119
Sponsors and Collaborators
Ophthotech Corporation
More Information
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Responsible Party: Denise Teuber, Ophthotech Corp
ClinicalTrials.gov Identifier: NCT00569140    
Other Study ID Numbers: OPH 1000
First Posted: December 6, 2007    Key Record Dates
Last Update Posted: January 25, 2010
Last Verified: January 2010
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases