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| Sponsor: | Ophthotech Corporation |
|---|---|
| Information provided by (Responsible Party): | Ophthotech Corporation |
| ClinicalTrials.gov Identifier: | NCT00709527 |
Purpose
The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic profile of multiple doses of ARC1905 intravitreous injection when administered in combination with multiple doses of Lucentis® 0.5 mg/eye, or with one induction dose of 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: ARC1905 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Ascending Dose And Parallel Group Trial To Establish The Safety, Tolerability AND Pharmacokinetic Profile Of Multiple Intravitreous Injections Of ARC1905 (ANTI-C5 APTAMER) Given Either In Combination Therapy With Multiple Doses Of Lucentis® 0.5 mg/Eye, Or With One Induction Dose Of Lucentis® 0.5 mg/Eye In Subjects With Neovascular Age-Related Macular Degeneration |
| Estimated Enrollment: | 70 |
| Study Start Date: | July 2008 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: ARC1905
intravitreal injection
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Ophthotech Corporation |
| ClinicalTrials.gov Identifier: | NCT00709527 History of Changes |
| Other Study ID Numbers: | OPH2000 |
| Study First Received: | July 1, 2008 |
| Last Updated: | October 4, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
AMD |
|
Macular Degeneration Wet Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |