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

Phase 2

Terminated

• Conditions: Posterior Vitreous Detachment; Diabetic Retinopathy; Disease Progression
• Interventions: Drug: ocriplasmin 0.0625mg; Drug: ocriplasmin 0.125mg; Drug: Sham injection

• Registration Number: NCT02681809
• Lead Sponsor: ThromboGenics

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-02-05
• Study First Submitted QC: 2016-02-09
• Study First Posted: 2016-02-12
• Primary Completion: 2019-11-18
• Study Completion: 2019-11-18
• Results First Submitted: 2020-11-12
• Status Verified: 2020-12
• Results First Submitted QC: 2020-12-08
• Last Update Submitted: 2020-12-08
• Results First Posted: 2020-12-16
• Last Update Posted: 2020-12-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ocriplasmin 0.0625mg	ocriplasmin 0.0625mg	-
Ocriplasmin 0.125mg	ocriplasmin 0.125mg	-
Sham injection	Sham injection	-

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Total PVD by the Month 3 Visit	Month 3	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

Secondary Outcome Measures

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