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

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)

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).

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