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| Sponsor: | Paloma Pharmaceuticals, Inc. |
|---|---|
| Information provided by: | Paloma Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01033721 |
Purpose
Palomid 529 is a dual TORC1/2 inhibitor of the PI3K/Akt/mTOR pathway having broad activity in angiogenesis and cellular proliferation. Palomid 529 will be examined to determine if the safety, tolerability and pharmacokinetic profile of single ascending doses when administered intravitreally or subconjunctivally.
| Condition | Intervention | Phase |
|---|---|---|
|
Age-Related Macular Degeneration |
Drug: Palomid 529 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Open-Label Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of Single Intravitreal and Subconjunctival Doses of Palomid 529 in Patients With Advanced Neovascular Age-Related Macular Degeneration (AMD) |
| Estimated Enrollment: | 33 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
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| Contact: Jeffrey S. Heier, M.D. | 617-367-4800 | jsheier@eyeboston.com |
| Contact: Alison Nowak | 617-314-2694 | anowak@eyeboston.com |
| United States, Massachusetts | |
| Ophthalmic Consultants of Boston | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Jeffrey S. Heier, M.D. 617-367-4800 jsheier@eyeboston.com | |
| Contact: Alison Nowak 617-314-2694 anowak@eyeboston.com | |
| Principal Investigator: Jeffrey S. Heier, M.D. | |
| Principal Investigator: | Jeffrey S. Heier, M.D. | Ophthalmic Consultants of Boston |
More Information
| Responsible Party: | David Sherris, Paloma Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01033721 History of Changes |
| Other Study ID Numbers: | Paloma P529 Ocular |
| Study First Received: | December 15, 2009 |
| Last Updated: | July 15, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Macular Degeneration Wet Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |