Overview

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

Status:
Terminated
Trial end date:
2019-11-18
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
ThromboGenics
Treatments:
Fibrinolysin
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