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

ThromboGenics

Status and phase: Terminated; Phase 2

Conditions: Disease Progression; Posterior Vitreous Detachment; Diabetic Retinopathy

Treatments: Drug: Sham injection; Drug: ocriplasmin 0.125mg; Drug: ocriplasmin 0.0625mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02681809

TG-MV-015

2015-002415-15 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 3 patient groups

Ocriplasmin 0.0625mg

Experimental group

Treatment:

Drug: ocriplasmin 0.0625mg

Ocriplasmin 0.125mg

Experimental group

Treatment:

Drug: ocriplasmin 0.125mg

Sham injection

Sham Comparator group

Treatment:

Drug: Sham injection