Completed

NCT Number: NCT01429441

Ocriplasmin for 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.

Completed

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Key information

Conditions

Vitreomacular Adhesion Including Macular Hole

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Retinal Consultants of Arizona, Phoenix, Arizona, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ocriplasmin

Drug

0.125 mg single intravitreal injection

Sham Injection

Other

Sham injection

Primary outcomes

Proportion of Subjects With Pharmacological Vitreomacular Adhesion (VMA) / (Vitreomacular Traction [VMT]) Resolution at Day 28

Time frame: Day 28

Pharmacological VMA resolution without anatomical defect, based on SD-OCT and determined by the masked central reading center (CRC), with post-resolution vitrectomy considered as a failure. Missing data were imputed using the last observation carried forward (LOCF) method.

Secondary outcomes

Proportion of Subjects With a ≥2 Lines Improvement in Best-corrected Visual Acuity (BCVA) From Baseline at Month 24

Time frame: Month 24

≥2 lines improvement in BCVA from baseline, irrespective of vitrectomy. Missing data were imputed using the LOCF method.

Sponsors and collaborators

Lead sponsor

ThromboGenics

Industry

Registry information

Official study title

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

Acronym: OASIS

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Sep 7, 2011
Registry last updated: Mar 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.