Conditions: Vitrectomy
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 38
Healthy volunteers: no

Brief summary:
To evaluate the pharmacokinetic properties of intravitreal ocriplasmin 125 µg dose when administered at different time-points prior to planned primary pars plana vitrectomy (PPV)

Detailed description:
Open-label, ascending-exposure-time, single center trial in which a total of 36 subjects will be enrolled. The time to remove the vitreous will be recorded and a vitreous sample will be obtained at the beginning of vitrectomy for determination of ocriplasmin activity; 32 subjects will receive 125 μg ocriplasmin intravitreal injection prior to vitrectomy and 4 subjects will not receive ocriplasmin intravitreal injection prior to vitrectomy (control arm).

Study drug will be administered in the mid-vitreous by injection. The study eye will be examined after study drug injection to exclude retinal non-perfusion or other complications.

Arms:
arm 1: Primary Pars Plana Vitrectomy 5 to 30 minutes after 125µg of ocriplasmin intravitreal injection arm 2: Primary Pars Plana Vitrectomy 31 to 60 minutes after 125µg of ocriplasmin intravitreal injection arm 3: Primary Pars Plana Vitrectomy 2 to 4 hours after 125µg of ocriplasmin intravitreal injection arm 4: Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125µg of ocriplasmin intravitreal injection arm 5: Primary Pars Plana Vitrectomy 7 days (+1 day)after 125µg of ocriplasmin intravitreal injection arm 6: Control Arm, no ocriplasmin intravitreal injection

Interventions: intervention 1: ocriplasmin intervention 2: ocriplasmin intervention 3: ocriplasmin intervention 4: ocriplasmin intervention 5: ocriplasmin
Intervention descriptions: intervention 1: 125µg ocriplasmin intravitreal injection intervention 2: 125µg ocriplasmin intravitreal injection intervention 3: 125µg ocriplasmin intravitreal injection intervention 4: 125µg ocriplasmin intravitreal injection intervention 5: 125µg ocriplasmin intravitreal injection

Protocol document: