Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Ophthotech Corporation |
---|---|
Information provided by: | Ophthotech Corporation |
ClinicalTrials.gov Identifier: | NCT00709527 |
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: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
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 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: ARC1905
intravitreal injection
|
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Ophthotech Corp | Recruiting |
New York, New York, United States, 10119 | |
Contact: Desiree Beutelspacher 212-845-8214 dbeutelspacher@ophthotech.com |
Responsible Party: | Ophthotech Corp ( Desiree Beutelspacher ) |
Study ID Numbers: | OPH2000 |
Study First Received: | July 1, 2008 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00709527 |
Health Authority: | United States: Food and Drug Administration |
AMD |
Eye Diseases Retinal Degeneration Macular Degeneration Retinal Diseases Retinal degeneration |