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)

ThromboGenics0 sites48 target enrollmentDecember 2015

ConditionsDiabetic Retinopathy Posterior Vitreous Detachment Disease Progression

Interventionsocriplasmin 0.0625mg ocriplasmin 0.125mg Sham injection

Drugsocriplasmin 0.0625mg ocriplasmin 0.125mg Sham injection

Overview

Phase: Phase 2
Intervention: ocriplasmin 0.0625mg
Conditions: Diabetic Retinopathy
Sponsor: ThromboGenics
Enrollment: 48
Primary Endpoint: Number of Subjects With Total PVD by the Month 3 Visit
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

December 2015

End Date

November 18, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

ThromboGenics

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Ocriplasmin 0.0625mg

Intervention: ocriplasmin 0.0625mg

Ocriplasmin 0.125mg

Intervention: ocriplasmin 0.125mg

Sham injection

Intervention: Sham injection

Outcomes

Primary Outcomes

Number of Subjects With Total PVD by the Month 3 Visit

Time Frame: 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