Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole (OASIS)

ThromboGenics

Status and phase

Completed

Phase 3

Conditions

Vitreomacular Adhesion Including Macular Hole

Treatments

Other: Sham injection

Drug: Ocriplasmin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01429441

TG-MV-014

Details and patient eligibility

About

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

Full description

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.

Enrollment

220 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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