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Ocriplasmin for VMT/sVMA
NCT02035748Phase 4
Key facts
- Status
- Completed
- Start
- Apr 2014
- Primary completion
- Sep 2015
- Sponsor
- Alcon Inc.
- Modality
- Therapeutic Enzymes
- Drugs
- ocriplasmin
- Conditions
- vitreomacular traction (VMT)vitreomacular adhesion (VMA)
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Overview
Phase 4, open-label, single-arm trial of ocriplasmin in vitreomacular traction (VMT) and vitreomacular adhesion (VMA), sponsored by Alcon Inc. Primary endpoint: Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Traction (VMT/VMA) at Day 28. Started Apr 2014; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Ocriplasmin
Single intravitreal injection of Ocriplasmin
03
Who it enrols
Patients with VMT/sVMA and focal VMA on SD-OCT. Excludes patients with broad VMT >1500 microns, large macular holes >400 microns, high myopia, ERM, or history of vitrectomy.
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Endpoints
Primary
Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Traction (VMT/VMA)
Secondary
Nonsurgical Change From Baseline in Best-corrected Visual Acuity (BCVA) at Distance
Proportion of Subjects With Nonsurgical Closure of Macular Hole (MH)
Proportion of Subjects With Nonsurgical Resolution of VMT/sVMA
Proportion of Subjects Experiencing Pars Plana Vitrectomy (PPV)
Mean Nonsurgical Change From Baseline in Central Foveal Thickness (CFT)
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