Study Stopped
Slow recruitment rate
A Study to Evaluate the Efficacy and Safety of Ocriplasmin in Inducing Total PVD in Subjects With NPDR
CIRCLE
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)
2 other identifiers
interventional
48
9 countries
38
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2015
Typical duration for phase_2
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 5, 2016
CompletedFirst Posted
Study publicly available on registry
February 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 18, 2019
CompletedResults Posted
Study results publicly available
December 16, 2020
CompletedDecember 16, 2020
December 1, 2020
4 years
February 5, 2016
November 12, 2020
December 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Number of Subjects With Ocular Treatment-emergent Adverse Events in the Study Eye
From first injection until the end of the study (Month 24)
Study Arms (3)
Ocriplasmin 0.0625mg
EXPERIMENTALOcriplasmin 0.125mg
EXPERIMENTALSham injection
SHAM COMPARATORInterventions
Up to 3 intravitreal injections of ocriplasmin 0.0625mg approximately 1 month apart
Up to 3 intravitreal injections of ocriplasmin 0.125mg approximately 1 month apart
3 sham injections approximately 1 month apart. No actual injections. No medication is used.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ThromboGenicslead
Study Sites (38)
Unknown Facility
Phoenix, Arizona, 85021, United States
Unknown Facility
Campbell, California, 95008, United States
Unknown Facility
Irvine, California, 92697, United States
Unknown Facility
Loma Linda, California, 92354, United States
Unknown Facility
Santa Ana, California, 92705, United States
Unknown Facility
Rapid City, South Dakota, 57701, United States
Unknown Facility
McAllen, Texas, 78503, United States
Unknown Facility
San Antonio, Texas, 78240, United States
Unknown Facility
Charlottesville, Virginia, 22903, United States
Unknown Facility
Brno, 625 00, Czechia
Unknown Facility
Hradec Králové, 500 05, Czechia
Unknown Facility
Olomouc, 779 00, Czechia
Unknown Facility
Pardubice, 530 02, Czechia
Unknown Facility
Prague, 100 34, Czechia
Unknown Facility
Prague, 140 00, Czechia
Unknown Facility
Zlín, 760 01, Czechia
Unknown Facility
Paris, 75475, France
Unknown Facility
München, Bavaria, 80336, Germany
Unknown Facility
Darmstadt, Hesse, 64297, Germany
Unknown Facility
Leipzig, Saxony, 04103, Germany
Unknown Facility
Debrecen, Hajdú-Bihar, 4032, Hungary
Unknown Facility
Budapest, 1062, Hungary
Unknown Facility
Budapest, 1083, Hungary
Unknown Facility
Budapest, 1106, Hungary
Unknown Facility
Budapest, 1133, Hungary
Unknown Facility
Szombathely, 9700, Hungary
Unknown Facility
Beersheba, 84101, Israel
Unknown Facility
Petah Tikva, 4941492, Israel
Unknown Facility
Rehovot, 7610001, Israel
Unknown Facility
Tel Aviv, 6423906, Israel
Unknown Facility
Milan, 20132, Italy
Unknown Facility
Barcelona, 08195, Spain
Unknown Facility
Barcelona, 8025, Spain
Unknown Facility
Girona, 17007, Spain
Unknown Facility
Valladolid, 47012, Spain
Unknown Facility
Frimley, Surrey, GU16 7UJ, United Kingdom
Unknown Facility
London, EC1V 2PD, United Kingdom
Unknown Facility
London, SE5 9RS, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Recruitment in the study was discontinued early due to slow recruitment rate. This led to 48 randomized subjects instead of the planned 115. By consequence, the study was not powered for its primary endpoint, which was evaluated only descriptively.
Results Point of Contact
- Title
- Global Clinical Development
- Organization
- ThromboGenics
Study Officials
- STUDY DIRECTOR
Clinical Department
ThromboGenics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2016
First Posted
February 12, 2016
Study Start
December 1, 2015
Primary Completion
November 18, 2019
Study Completion
November 18, 2019
Last Updated
December 16, 2020
Results First Posted
December 16, 2020
Record last verified: 2020-12