Phase 3 N=220 Randomized Quadruple-blind Treatment

Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole

Vitreomacular Adhesion Including Macular Hole

Bottom Line

View on ClinicalTrials.gov: NCT01429441 ↗

Enrolled (actual)

220

Serious AEs

34.6%

Results posted

Jan 2016

Primary outcome: Primary: Proportion of Subjects With Pharmacological Vitreomacular Adhesion (VMA) / (Vitreomacular Traction [VMT]) Resolution at Day 28 — 41.7; 6.2 Percentage (weighted across strata)

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ocriplasmin (Drug); Sham injection (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: ThromboGenics
Primary completion: Oct 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Subjects With Pharmacological Vitreomacular Adhesion (VMA) / (Vitreomacular Traction [VMT]) Resolution at Day 28	41.7; 6.2	—
SECONDARY Proportion of Subjects With a ≥2 Lines Improvement in Best-corrected Visual Acuity (BCVA) From Baseline at Month 24	50.5; 39.1	—

Summary

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

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01429441). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.