Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ThromboGenics

Criteria

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