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Sponsored by: |
ThromboGenics |
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Information provided by: | ThromboGenics |
ClinicalTrials.gov Identifier: | NCT00798317 |
This trial will evaluate the safety and efficacy of microplasmin, administered as an intravitreal injection, in subjects with focal vitreomacular adhesion. In previously performed clinical trials, some patients treated with intravitreal microplasmin have had resolution of their underlying condition, including macular hole closure, without need for vitrectomy. This clinical trial is justified because the sponsor believes the potential benefits outweigh the potential risks.
Condition | Intervention | Phase |
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Focal Vitreomacular Adhesion |
Drug: Microplasmin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Placebo Controlled, Double-Masked, Multicenter Trial of Microplasmin Intravitreal Injection for Non-Surgical Treatment of Focal Vitreomacular Adhesion. |
Estimated Enrollment: | 320 |
Study Start Date: | December 2008 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Microplasmin
Intravitreal injection of 0.1 ml microplasmin solution containing 125ug of microplasmin.
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2: Placebo Comparator |
Drug: Microplasmin
Intravitreal injection of 0.1 ml placebo solution.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Katrien Delobelle | +32 16 751 333 | katrien.delobelle@thrombogenics.com |
Contact: Geraldine Cahillane | +353 1 4097757 | geraldine.cahillane@thrombogenics.com |
Responsible Party: | ThromboGenics ( Katrien Delobelle ) |
Study ID Numbers: | TG-MV-007 |
Study First Received: | November 25, 2008 |
Last Updated: | July 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00798317 History of Changes |
Health Authority: | Belgium: Directorate general for the protection of Public health: Medicines; Czech Republic: State Institute for Drug Control; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Poland: Ministry of Health; Portugal: National Pharmacy and Medicines Institute; Spain: Spanish Agency of Medicines; United States: Food and Drug Administration |
Adhesions |
Pathologic Processes Adhesions |