Study to Evaluate Plasmin for the Creation of a Posterior Vitreous Detachment
|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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00348439
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|