A Study to Evaluate the Efficacy and Safety of Ocriplasmin in Inducing Total PVD in Subjects With NPDR

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy and safety of up to 3 intravitreal injections of ocriplasmin (0.0625mg or 0.125mg), in subjects with moderate to very severe non-proliferative diabetic retinopathy (NPDR), to induce total posterior vitreous detachment (PVD) in order to reduce the risk of disease progression to proliferative diabetic retinopathy (PDR).

Official Title
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A Phase 2, Randomised, Double Masked, Sham Controlled, Multicentre Study to Evaluate the Efficacy and Safety of Ocriplasmin in Inducing Total Posterior Vitreous Detachment (PVD) in Subjects With Non-proliferative Diabetic Retinopathy (NPDR)

Conditions
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Diabetic Retinopathy, Posterior Vitreous Detachment, Disease Progression

Intervention / Treatment
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* Drug: ocriplasmin 0.0625mg
* Drug: ocriplasmin 0.125mg
* Drug: Sham injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged 18 years or older Best-corrected visual acuity (BCVA) of 65 letters read or greater (Snellen equivalent of 20/50 or better) in the study eye HbA1c ≤ 12%, as assessed by the central laboratory Moderate to very severe NPDR as per ETDRS Severity Scale, based on 7 standard field stereo colour fundus photograph Central subfield thickness of ≤ 340µm on Spectralis SD-OCT or ≤ 320µm on non-Spectralis SD OCT in the study eye, with or without mild centre-involved diabetic macular oedema No evidence of total PVD in the study eye Written informed consent obtained from the subject prior to screening procedures Exclusion Criteria: History of or current ocular condition in the study eye that may interfere with the assessment of the progression to PDR Presence of epiretinal membrane in the study eye Presence of foveal ischemia in the study eye Presence of pre-retinal or vitreous haemorrhage in the study eye Presence of iris or angle neovascularisation in the study eye Any active ocular / intraocular infection or inflammation in either eye Aphakic study eye Uncontrolled hypertension in the opinion of the Investigator Pseudoexfoliation, Marfan's syndrome, phacodonesis or any other finding in the Investigator's opinion suggesting lens / zonular instability

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ocriplasmin 0.0625mg<br> | Drug: ocriplasmin 0.0625mg<br>* Up to 3 intravitreal injections of ocriplasmin 0.0625mg approximately 1 month apart<br>|
| Experimental: Ocriplasmin 0.125mg<br> | Drug: ocriplasmin 0.125mg<br>* Up to 3 intravitreal injections of ocriplasmin 0.125mg approximately 1 month apart<br>|
| Sham Comparator: Sham injection<br> | Drug: Sham injection<br>* 3 sham injections approximately 1 month apart. No actual injections. No medication is used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Total PVD by the Month 3 Visit | Total PVD should be confirmed on both B-scan ultrasound and spectral domain optical coherence tomography (SD-OCT), as assessed by the masked central reading centres | Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Ocular Treatment-emergent Adverse Events in the Study Eye | Adverse events were identified by ophthalmic assessments (including BCVA assessment, full ophthalmic examination and ocular imaging) and by subject reporting | From first injection until the end of the study (Month 24) |