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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase III Study of A01016 125μg Intravitreal Injection in Subjects With Symptomatic Vitreomacular Adhesion - Comparison Study to Sham Injection

Conditions
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Symptomatic Vitreomacular Adhesion

Intervention / Treatment
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* Drug: Ocriplasmin
* Drug: Sham injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ocriplasmin<br>Ocriplasmin administered as a single intravitreal injection to the study eye at baseline | Drug: Ocriplasmin<br> <br> * Other names: A01016;|
| Sham Comparator: Sham injection<br>Single sham injection to the study eye at baseline | Drug: Sham injection<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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