Vitreoretinal Traction Syndrome
Conditions
Brief summary
Plasmin is expected to create a posterior vitreous detachment. The pharmacological creation of a posterior vitreous detachment may be beneficial in a variety of conditions.
Interventions
DRUGPlasmin
27 mg of human-derived plasmin to be reconstituted with 0.9% Sterile Sodium Chloride for a single intravitreal injection.
DRUGVehicle
Plasmin formulation, without active ingredient to be reconstituted in 0.9% Sterile Sodium Chloride and administered in a single intravitreal injection.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who would benefit from a posterior vitreous detachment, as determined by the evaluating ophthalmologist.
Exclusion criteria
* Presence of a posterior vitreous detachment in the study eye * History of vitrectomy in the study eye * Proliferative diabetic retinopathy in the study eye * Presence of media opacity that precludes quality examination of the vitreous and fundus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of a Grade A Posterior Vitreous Detachment (PVD) | 14 Days | PVD at the disc and macula post plamin injection |
Countries
United States
Outcome results
None listed