Back to resultsA Phase III Study of A01016 in Subjects With Symptomatic Vitreomacular Adhesion
Primary Purpose
Symptomatic Vitreomacular Adhesion
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Ocriplasmin
Sham injection
Sponsored by
About this trial
This is an interventional treatment trial for Symptomatic Vitreomacular Adhesion focused on measuring 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
Eligibility 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.
Sites / Locations
- Contact Alcon for Trial Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Ocriplasmin
Sham injection
Arm Description
Ocriplasmin administered as a single intravitreal injection to the study eye at baseline
Single sham injection to the study eye at baseline
Outcomes
Primary Outcome Measures
Proportion of Subjects With Non-Surgical Resolution of Vitreomacular Adhesion (VMA)
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01889251
Brief Title
A Phase III Study of A01016 in Subjects With Symptomatic Vitreomacular Adhesion
Official Title
A Phase III Study of A01016 125μg Intravitreal Injection in Subjects With Symptomatic Vitreomacular Adhesion - Comparison Study to Sham Injection
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Vitreomacular Adhesion
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
251 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ocriplasmin
Arm Type
Experimental
Arm Description
Ocriplasmin administered as a single intravitreal injection to the study eye at baseline
Arm Title
Sham injection
Arm Type
Sham Comparator
Arm Description
Single sham injection to the study eye at baseline
Intervention Type
Drug
Intervention Name(s)
Ocriplasmin
Other Intervention Name(s)
A01016
Intervention Type
Drug
Intervention Name(s)
Sham injection
Primary Outcome Measure Information:
Title
Proportion of Subjects With Non-Surgical Resolution of Vitreomacular Adhesion (VMA)
Description
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.
Time Frame
Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Group Manager, Clinical Development
Organizational Affiliation
Alcon Japan, Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Contact Alcon for Trial Locations
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Phase III Study of A01016 in Subjects With Symptomatic Vitreomacular Adhesion
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