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Sponsored by: |
Ophthotech Corporation |
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Information provided by: | Ophthotech Corporation |
ClinicalTrials.gov Identifier: | NCT00569140 |
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 I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 18 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | December 2009 |
Arms | Assigned Interventions |
---|---|
1: No Intervention
E10030
|
Drug: E10030
Intravitreal injection
|
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subfoveal choroidal neovascularization (CNV) due to AMD
Exclusion Criteria:
Any of the following underlying diseases including:
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.
Contact: Denise Teuber | 212 845-8207 | denise.teuber@ophthotech.com |
United States, New York | |
Denise Teuber | Recruiting |
New York, New York, United States, 10119 |
Responsible Party: | Ophthotech Corp ( Denise Teuber ) |
Study ID Numbers: | OPH 1000 |
Study First Received: | December 4, 2007 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00569140 |
Health Authority: | United States: Food and Drug Administration |
Eye Diseases Retinal Degeneration Macular Degeneration Retinal Diseases Retinal degeneration |