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Sponsored by: |
Jerini Ophthalmic |
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Information provided by: | Jerini Ophthalmic |
ClinicalTrials.gov Identifier: | NCT00536016 |
The purpose of this study is to determine the way and rate that the study medication, JSM6427 a potent, highly specific integrin α5β1-antagonist is absorbed, broken-down and eliminated from the body when it is given as a single dosage strength by injection into the eye. Repeated dosages will also be given to determine the highest safe dose.
Condition | Intervention | Phase |
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Macular Degeneration |
Drug: JSM6427 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase 1 Open Label Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of Single and Repeated Doses of JSM6427 Following Administration by Intravitreal Injection in Patients With Neovascular AMD |
Estimated Enrollment: | 36 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
In non-clinical models, JSM6427 can lead to the inhibition and regression of choroidal neovascularization, making α5β1 an attractive target for therapeutic strategies directed at pathological angiogenesis. JSM6427 may also interfere with other key processes in the pathogenesis of AMD, namely inflammation and fibrosis. Further, non-clinical data show that JSM6427 inhibits scarring and inflammation. Thus, JSM6427 may target multiple important pathways in the pathogenesis of neovascular AMD.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Adrienne Berman, MD | 949-759-1004 | iolite.consulting@gmail.com |
Contact: Robert Miller, MD | (919) 226 1440 ext 325 | Robert.Miller@fulcrumpharma.com |
United States, California | |
Retina Vitreous Associates Medical Group | Not yet recruiting |
Beverly Hills, California, United States, 90211 | |
Contact: Janet Kurokoushi 310-652-1956 jkurokoushi@msn.com | |
Principal Investigator: David Boyer, MD | |
United States, Massachusetts | |
Ophthalmic Consultants of Boston | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Emily Corey 617-314-2608 ecorey@eyeboston.com | |
Principal Investigator: Jeffrey Heier, MD | |
United States, Michigan | |
William Beaumont Research Institute | Recruiting |
Royal Oak, Michigan, United States, 40873 | |
Contact: Tammy Osentowski, BSN 248-551-9866 Tosentowski@beaumont.edu | |
Principal Investigator: George A. Williams, MD | |
United States, Oklahoma | |
Dean McGee Eye Institute | Not yet recruiting |
Oklahoma City, Oklahoma, United States, 73120 | |
Contact: Misty Youngberg 405-271-6307 misty-youngberg@dmei.org | |
Principal Investigator: Robert Leonard, MD | |
United States, South Carolina | |
Palmetto Retina Center | Recruiting |
West Columbia, South Carolina, United States, 29169 | |
Contact: Mallie Taylor 803-744-0144 mtaylor@palmettoretina.com | |
Principal Investigator: John Wells, MD | |
United States, South Dakota | |
Black Hills Regional Eye Institute | Recruiting |
Rapid City, South Dakota, United States, 57701 | |
Contact: Honor Evers 605-719-3308 hevers@bhrei.com | |
Principal Investigator: Prema Abraham, MD | |
United States, Texas | |
Valley Retina Institute | Recruiting |
McAllen, Texas, United States, 78503 | |
Contact: Aaron Guel 956-631-8875 aag@vritx.com | |
Principal Investigator: Victor Gonzalez, MD | |
Retina Research Institute of Texas | Recruiting |
Abilene, Texas, United States, 79606 | |
Contact: Angela Jaimes 325-690-4414 angela@westtexasretina.com | |
Principal Investigator: Sunil Patel, MD | |
Vitreoretinal Consultants | Not yet recruiting |
Houston, Texas, United States, 77030 | |
Contact: Jolene Carranza jolene.carranza@houstonretina.com | |
Principal Investigator: David Brown, MD |
Study Chair: | Anthony Adamis, MD | Jerini Ophthalmic |
Responsible Party: | Jerini Ophthalmic ( Anthony Adamis, MD CEO and President ) |
Study ID Numbers: | JO642701 |
Study First Received: | September 25, 2007 |
Last Updated: | June 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00536016 History of Changes |
Health Authority: | United States: Food and Drug Administration |
AMD Neovascular Age-Related Macular Degeneration |
Eye Diseases Retinal Degeneration Macular Degeneration Retinal Diseases |
Eye Diseases Retinal Degeneration Macular Degeneration Retinal Diseases |