- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01889251
A Phase III Study of A01016 in Subjects With Symptomatic Vitreomacular Adhesion
November 2, 2015 updated by: Alcon Research
A Phase III Study of A01016 125μg Intravitreal Injection in Subjects With Symptomatic Vitreomacular Adhesion - Comparison Study to Sham Injection
The purpose of this study is to evaluate the superiority regarding vitreomacular adhesion (VMA) resolution of a single intravitreal injection of A01016 (Ocriplasmin) compared to sham-injection in subjects with symptomatic VMA.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
251
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tokyo, Japan
- Contact Alcon for Trial Locations
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Symptomatic vitreomacular adhesion (VMA) which, in the opinion of the Investigator, is related to decreased visual function;
- Best corrected visual acuity (BCVA) of 20/25 or worse in the study eye;
- BCVA of 20/800 or better in the non-study eye;
- Provide written informed consent;
- Follow specified instructions during study period;
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Evidence of proliferative retinopathy, exudative age-related macular degeneration, or retinal vein occlusion in the study eye;
- Vitreous hemorrhage or other opacification;
- High myopia in the study eye;
- Ocular surgery, laser photocoagulation treatment, or intravitreal injection(s) in the study eye in the prior 3 months;
- Uncontrolled glaucoma in the study eye;
- History of retinal detachment in either eye;
- Active infection in either eye;
- Pregnant or of child-bearing potential and not utilizing acceptable form of contraception;
- Participation in another investigational drug study within 30 days prior to this study;
- Other protocol-defined exclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Ocriplasmin
Ocriplasmin administered as a single intravitreal injection to the study eye at baseline
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Other Names:
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SHAM_COMPARATOR: Sham injection
Single sham injection to the study eye at baseline
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Subjects With Non-Surgical Resolution of Vitreomacular Adhesion (VMA)
Time Frame: Day 28
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VMA (adhesion of the vitreous gel to the retina in an abnormally strong manner) was determined by masked Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT) evaluation.
Only one eye (study eye) was analyzed.
Proportion of subjects is reported as a percentage.
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Day 28
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (ACTUAL)
September 1, 2014
Study Completion (ACTUAL)
September 1, 2014
Study Registration Dates
First Submitted
June 26, 2013
First Submitted That Met QC Criteria
June 26, 2013
First Posted (ESTIMATE)
June 28, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
November 30, 2015
Last Update Submitted That Met QC Criteria
November 2, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- J-12-075
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Symptomatic Vitreomacular Adhesion
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ThromboGenicsCompletedSymptomatic Vitreomacular AdhesionUnited States
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ThromboGenicsCompletedSymptomatic Vitreomacular AdhesionUnited States, Belgium
-
Allegro Ophthalmics, LLCCompletedSymptomatic Focal Vitreomacular AdhesionUnited States
-
ThromboGenicsCompletedSymptomatic Vitreomacular Adhesion (VMA)United States
-
Jeffrey S HeierKato Pharmaceuticals, Inc.CompletedVitreomacular Traction | Vitreomacular Adhesion | Vitreomacular AttachmentUnited States
-
Alcon ResearchCompletedVitreomacular Traction | Vitreomacular AdhesionAustralia
-
Alcon ResearchCompletedVitreomacular Traction | Vitreomacular Adhesion
-
ThromboGenicsCompletedVitreomacular AdhesionUnited States
-
ThromboGenicsCompletedVitreomacular AdhesionUnited States, Spain, United Kingdom, Germany, Belgium, Czech Republic, Poland
-
ThromboGenicsCompletedFocal Vitreomacular AdhesionBelgium
Clinical Trials on Sham injection
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The Jerzy Kukuczka Academy of Physical Education...Universitätsklinikum Hamburg-EppendorfCompleted
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Wuhan Neurophth Biotechnology Limited CompanyRecruitingLeber's Hereditary Optic Neuropathy (LHON)China
-
Taipei Medical University WanFang HospitalUnknown
-
Taipei Medical University WanFang HospitalCompletedMyofascial Pain SyndromeTaiwan
-
Chengdu Kanghong Biotech Co., Ltd.CompletedCentral Retinal Vein Occlusion | Macular EdemaChina
-
Chengdu Kanghong Biotech Co., Ltd.UnknownDiabetic Macular EdemaChina
-
Quark PharmaceuticalsTerminatedNon Arteritic Anterior Ischemic Optic NeuropathyUnited States, Australia, Germany, China, India, Italy, Singapore, Israel
-
ThromboGenicsCompletedVitreomacular Adhesion Including Macular HoleUnited States
-
ThromboGenicsCompletedExudative Age-Related Macular Degeneration | Focal Vitreomacular AdhesionUnited States, United Kingdom, Germany, France, Belgium, Italy
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The Jerzy Kukuczka Academy of Physical Education...University of LuebeckCompleted