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A Phase III Study of A01016 in Subjects With Symptomatic Vitreomacular Adhesion

This study has been completed.
Information provided by (Responsible Party):
Alcon Research Identifier:
First received: June 26, 2013
Last updated: November 2, 2015
Last verified: November 2015
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.

Condition Intervention Phase
Symptomatic Vitreomacular Adhesion Drug: Ocriplasmin Drug: Sham injection Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III Study of A01016 125μg Intravitreal Injection in Subjects With Symptomatic Vitreomacular Adhesion - Comparison Study to Sham Injection

Resource links provided by NLM:

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Proportion of Subjects With Non-Surgical Resolution of Vitreomacular Adhesion (VMA) [ Time Frame: Day 28 ]
    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.

Enrollment: 251
Study Start Date: July 2013
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ocriplasmin
Ocriplasmin administered as a single intravitreal injection to the study eye at baseline
Drug: Ocriplasmin
Other Name: A01016
Sham Comparator: Sham injection
Single sham injection to the study eye at baseline
Drug: Sham injection


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01889251

Contact Alcon for Trial Locations
Tokyo, Japan
Sponsors and Collaborators
Alcon Research
Study Director: Group Manager, Clinical Development Alcon Japan, Ltd.
  More Information

Responsible Party: Alcon Research Identifier: NCT01889251     History of Changes
Other Study ID Numbers: J-12-075
Study First Received: June 26, 2013
Results First Received: September 30, 2015
Last Updated: November 2, 2015

Keywords provided by Alcon Research:
Vitreomacular Adhesion
Vitreomacular Traction
Vitreomacular Traction Syndrome
Central Visual Field Defect
Blind Spot
Intravitreal Injection
Decreased Visual Acuity
Visual Complaint
Macular Hole

Additional relevant MeSH terms:
Tissue Adhesions
Pathologic Processes processed this record on September 21, 2017