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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

ThromboGenics

ClinicalTrials.gov Identifier:

NCT01429441

First received: September 2, 2011

Last updated: February 18, 2016

Last verified: January 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

September 2, 2011

Last Updated Date

February 18, 2016

Start Date ^ICMJE

October 2011

Primary Completion Date

October 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

VMA resolution [ Time Frame: Day 28 ]

Change History

Complete list of historical versions of study NCT01429441 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole

Official Title ^ICMJE

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

Brief Summary

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

Detailed 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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Vitreomacular Adhesion Including Macular Hole

Intervention ^ICMJE

Drug: Ocriplasmin
0.125 mg single intravitreal injection
Other: Sham injection
Sham injection

Study Arms

Experimental: Ocriplasmin
Intervention: Drug: Ocriplasmin
Sham Comparator: Sham injection
Intervention: Other: Sham injection

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

220

Completion Date

October 2014

Primary Completion Date

October 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01429441

Other Study ID Numbers ^ICMJE

TG-MV-014

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

ThromboGenics

Study Sponsor ^ICMJE

ThromboGenics

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

ThromboGenics

Verification Date

January 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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