Study to Evaluate Plasmin for the Creation of a Posterior Vitreous Detachment
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|ClinicalTrials.gov Identifier: NCT00348439|
Recruitment Status : Terminated (Lack of Efficacy)
First Posted : July 4, 2006
Last Update Posted : December 8, 2011
|Condition or disease||Intervention/treatment||Phase|
|Disorders Caused by Vitreo-retinal Traction.||Drug: Plasmin Drug: Vehicle||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multicenter, Randomized, Double Masked, Placebo Controlled, Sequential Dose Response Study of Intravitreally Administered Plasmin for the Creation of a Posterior Vitreous Detachment (PVD)|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||August 2007|
|Actual Study Completion Date :||August 2007|
Experimental: Plasmin Injection
27 mg of human-derived plasmin to be reconstituted with 0.9% Sterile Sodium Chloride for a single intravitreal injection.
Placebo Comparator: Vehicle
Plasmin formulation, without active ingredient.
Plasmin formulation, without active ingredient to be reconstituted in 0.9% Sterile Sodium Chloride and administered in a single intravitreal injection.
- Presence of a Grade A Posterior Vitreous Detachment (PVD) [ Time Frame: 14 Days ]PVD at the disc and macula post plamin injection
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00348439
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|