Safety and Efficacy Study of Intravitreal Ocriplasmin in Subjects With AMD With Focal Vitreomacular Adhesion

Study Overview
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Brief Summary
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This study will evaluate the safety and efficacy of Ocriplasmin intravitreal injection, in subjects diagnosed with exudative AMD with focal vitreomacular adhesion. Ultimately, it is believed that intravitreal ocriplasmin may offer physicians a safe agent for pharmacologic vitreolysis and nonsurgical resolution of focal vitreomacular adhesion in AMD subjects where this adhesion may be causally associated with worse prognosis).

Official Title
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A Randomized, Sham-Injection Controlled, Double-Masked, Multicenter Trial of Ocriplasmin Intravitreal Injection for Treatment of Focal Vitreomacular Adhesion in Subjects With Exudative Age-Related Macular Degeneration (AMD)

Conditions
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Exudative Age-Related Macular Degeneration, Focal 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: Male or female subjects aged > 50 Presence of focal vitreomacular adhesion measured by Optical Coherence Tomography (OCT). Diagnosis of active primary or recurrent subfoveal CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component. The total area of Choroidal Neovascularization (CNV) (including both classic and occult components) encompassed within the lesion must be > 50% of the total lesion area The total lesion area must be < 12 disc areas Subjects who have previously received at least three antiangiogenic injections(Lucentis® or Avastin®) in the study eye. Subjects with visual acuity of 20/32 to 20/200 in the study eye Written informed consent obtained from the subject prior to inclusion in the study Exclusion Criteria: Evidence of complete macular Posterior Vitreous Detachment (PVD) in the study eye on biomicroscopy, B-scan ultrasound or OCT prior to planned study drug injection Subjects with vitreous haemorrhage which precludes either of the following: visualization of the posterior pole by visual inspection or adequate assessment of the macula by either OCT and/or fluorescein angiography in the study eye or other opacities precluding visualisation of the fundus. Subjects who have previously received more than 9 antiangiogenic agent injections (whether Lucentis® or Avastin® or other anti-angiogenic agent) in the study eye Subjects with history of rhegmatogenous retinal detachment or proliferative vitreoretinopathy (PVR) in the study eye Subjects with high myopia (> 8D) or aphakia in the study eye Subjects who have had ocular surgery in the study eye in the prior three months Subjects who have had a vitrectomy in the study eye at any time.

Ages Eligible for Study
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Minimum Age: 50 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> | Drug: Ocriplasmin<br>* ocriplasmin intravitreal injection (125 µg)<br>|
| Sham Comparator: Sham injection<br> | Drug: 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 Focal Vitreomacular Adhesion (VMA) Release by Day 28 | The VMA release was determined by masked Central Reading Center Optical Coherence Tomography (OCT) evaluation | Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMD