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

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ClinicalTrials.gov Identifier: NCT01889251
Recruitment Status : Completed
First Posted : June 28, 2013
Results First Posted : October 29, 2015
Last Update Posted : November 30, 2015
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
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 or disease Intervention/treatment Phase
Symptomatic Vitreomacular Adhesion Drug: Ocriplasmin Drug: Sham injection Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 251 participants
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
Study Start Date : July 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions
Drug Information available for: Ocriplasmin
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.



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

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.

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


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

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01889251     History of Changes
Other Study ID Numbers: J-12-075
First Posted: June 28, 2013    Key Record Dates
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
Vitrectomy
Central Visual Field Defect
Blind Spot
Intravitreal Injection
Macula
Retina
Decreased Visual Acuity
Visual Complaint
SD-OCT
Macular Hole

Additional relevant MeSH terms:
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes