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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: June 28, 2013
Last Update Posted: November 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research
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


Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT01889251     History of Changes
Other Study ID Numbers: J-12-075
First Submitted: June 26, 2013
First Posted: June 28, 2013
Results First Submitted: September 30, 2015
Results First Posted: October 29, 2015
Last Update Posted: November 30, 2015
Last Verified: November 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