- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00569140
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
February 20, 2024 updated by: Ophthotech Corporation
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
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).
Study Overview
Study Type
Interventional
Enrollment (Estimated)
18
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10119
- Denise Teuber
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 1
E10030
|
Intravitreal injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ophthalmic DLTs
Time Frame: immediate
|
immediate
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
adverse events
Time Frame: immendiate
|
immendiate
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
December 4, 2007
First Submitted That Met QC Criteria
December 5, 2007
First Posted (Estimated)
December 6, 2007
Study Record Updates
Last Update Posted (Estimated)
February 21, 2024
Last Update Submitted That Met QC Criteria
February 20, 2024
Last Verified
January 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPH 1000
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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