To evaluate the safety and preliminary efficacy of intravitreal microplasmin as an adjunct to conventional vitrectomy for the treatment of pediatric patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
175µg ocriplasmin intravitreal injection
Placebo intravitreal injection
Associated Retina Consultants
Royal Oak, Michigan, United States
Percentage of Eyes With Total Macular Posterior Vitreous Detachment (PVD).
Percentage of eyes with total macular PVD (to the vascular ridge in eyes with ROP) at the beginning of vitrectomy or after application of suction, as assessed by masked surgeon observation under the operating microscope.
Time frame: Beginning of vitrectomy or after application of suction
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