Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the treatment of symptomatic vitreomacular adhesion / (VMT) including macular hole with ocriplasmin.

Detailed Description
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The present study is designed to assess anatomical and functional outcomes following a single intravitreal injection of ocriplasmin 0.125mg in subjects with symptomatic vitreomacular adhesion (VMA)/ (VMT) including macular hole.

Official Title
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A Randomized, Sham-controlled, Double-masked, Multicenter Study Evaluating Ocriplasmin Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole

Conditions
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Vitreomacular Adhesion Including Macular Hole

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects 18 years of age or older and of either gender Presence of vitreomacular adhesion Best corrected visual acuity (BCVA) of 20/32 or worse in study eye BCVA of 20/800 or better in the non-study eye Exclusion Criteria: History or current evidence of proliferative retinopathy, exudative age-related macular degeneration (AMD) or retinal vein occlusion in the study eye Any vitreous hemorrhage or any other vitreous opacification which precludes the visualization of the posterior pole by visual inspection OR adequate assessment of the macula by spectral-domain optical coherence tomography (SD-OCT) in the study eye Macular hole of > 400 µm diameter in the study eye Presence of epiretinal membrane (ERM) Aphakia in the study eye High myopia (more than 8D) in study eye History of rhegmatogenous retinal detachment in either eye History of vitrectomy in the study eye Previous participation in this trial or prior administration of ocriplasmin in the study eye

Ages Eligible for Study
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Minimum Age: 18 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ocriplasmin<br> | Drug: Ocriplasmin<br>* 0.125 mg single intravitreal injection<br>|
| Sham Comparator: Sham injection<br> | Other: Sham injection<br>* Sham injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects With Pharmacological Vitreomacular Adhesion (VMA) / (Vitreomacular Traction [VMT]) Resolution at Day 28 | Pharmacological VMA resolution without anatomical defect, based on SD-OCT and determined by the masked central reading center (CRC), with post-resolution vitrectomy considered as a failure. Missing data were imputed using the last observation carried forward (LOCF) method. | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects With a ≥2 Lines Improvement in Best-corrected Visual Acuity (BCVA) From Baseline at Month 24 | ≥2 lines improvement in BCVA from baseline, irrespective of vitrectomy. Missing data were imputed using the LOCF method. | Month 24 |