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

Diabetic Retinopathy Clinical Trial

— CIRCLE  

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02681809
• Other study ID #: TG-MV-015
• Secondary ID: 2015-002415-15
• Status: Terminated
• Phase: Phase 2
• Start date: December 2015
• Est. completion date: November 18, 2019

Study information

• Verified date: December 2020
• Source: Oxurion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: November 18, 2019
• Est. primary completion date: November 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Disease Progression
• Posterior Vitreous Detachment
• Retinal Diseases
• Vitreous Detachment

Intervention

Drug:
• ocriplasmin 0.0625mg
Up to 3 intravitreal injections of ocriplasmin 0.0625mg approximately 1 month apart
• ocriplasmin 0.125mg
Up to 3 intravitreal injections of ocriplasmin 0.125mg approximately 1 month apart
• Sham injection
3 sham injections approximately 1 month apart. No actual injections. No medication is used.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ThromboGenics

Countries where clinical trial is conducted

United States,  Czechia,  France,  Germany,  Hungary,  Israel,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Total PVD by the Month 3 Visit	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	Month 3
Secondary	Number of Subjects With Ocular Treatment-emergent Adverse Events in the Study Eye	Adverse events were identified by ophthalmic assessments (including BCVA assessment, full ophthalmic examination and ocular imaging) and by subject reporting	From first injection until the end of the study (Month 24)