Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole

A Randomized, Sham-controlled, Double-masked, Multicenter Study Evaluating Ocriplasmin Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole

The purpose of this study is to evaluate the treatment of symptomatic vitreomacular adhesion / (VMT) including macular hole with ocriplasmin.

The present study is designed to assess anatomical and functional outcomes following a single intravitreal injection of ocriplasmin 0.125mg in subjects with symptomatic vitreomacular adhesion (VMA)/ (VMT) including macular hole.

Inclusion Criteria:

• Subjects 18 years of age or older and of either gender
• Presence of vitreomacular adhesion
• Best corrected visual acuity (BCVA) of 20/32 or worse in study eye
• BCVA of 20/800 or better in the non-study eye

Exclusion Criteria:

• History or current evidence of proliferative retinopathy, exudative age-related macular degeneration (AMD) or retinal vein occlusion in the study eye
• Any vitreous hemorrhage or any other vitreous opacification which precludes the visualization of the posterior pole by visual inspection OR adequate assessment of the macula by spectral-domain optical coherence tomography (SD-OCT) in the study eye
• Macular hole of > 400 µm diameter in the study eye
• Presence of epiretinal membrane (ERM)
• Aphakia in the study eye
• High myopia (more than 8D) in study eye
• History of rhegmatogenous retinal detachment in either eye
• History of vitrectomy in the study eye
• Previous participation in this trial or prior administration of ocriplasmin in the study eye