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Tracking Information | |||||
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First Received Date † | December 4, 2007 | ||||
Last Updated Date | January 9, 2009 | ||||
Start Date † | December 2007 | ||||
Current Primary Outcome Measures † |
Ophthalmic DLTs [ Time Frame: immediate ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00569140 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
adverse events [ Time Frame: immendiate ] [ Designated as safety issue: Yes ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | 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 | ||||
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 | ||||
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). |
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Detailed Description | |||||
Study Phase | Phase I | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study | ||||
Condition † | Age-Related Macular Degeneration | ||||
Intervention † | Drug: E10030 | ||||
Study Arms / Comparison Groups | No Intervention: E10030 | ||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Enrollment † | 18 | ||||
Estimated Completion Date | December 2009 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria: Subfoveal choroidal neovascularization (CNV) due to AMD Exclusion Criteria:
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. |
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Gender | Both | ||||
Ages | 50 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† |
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Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00569140 | ||||
Responsible Party | Denise Teuber, Ophthotech Corp | ||||
Secondary IDs †† | |||||
Study Sponsor † | Ophthotech Corporation | ||||
Collaborators †† | |||||
Investigators † | |||||
Information Provided By | Ophthotech Corporation | ||||
Verification Date | January 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |