Conditions: Vitreomacular Traction
Keywords: Vitreomacular Traction Maculopathy VMT PVD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 60
Healthy volunteers: no

Brief summary:
A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with vitreomacular traction.

Detailed description:

Arms:
arm 1: Ocriplasmin 75µg single injection versus sham injection arm 2: Ocriplasmin 125µg single injection versus sham injection arm 3: Ocriplasmin 175µg single injection versus sham injection arm 4: Ocriplasmin 125µg multiple injections. Subjects who did not achieve resolution of VMT by the day 28 visit (i.e. non-responders) were given an open-label injection of ocriplasmin 125µg. Subjects who still did not achieve resolution of VMT by the day 56 visit were given a second open-label injection of ocriplasmin 125µg. arm 5: sham injection

Interventions: intervention 1: ocriplasmin intervention 2: ocriplasmin intervention 3: Sham Comparator
Intervention descriptions: intervention 1: Intravitreal injection of ocriplasmin solution containing 75µg of ocriplasmin. intervention 2: Intravitreal injection of ocriplasmin solution containing 125µg of ocriplasmin with up to 2 additional (open label) 125µg ocriplasmin injection at 1 month interval. intervention 3: Intravitreal sham injection

Protocol document: