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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02681809
Recruitment Status : Completed
First Posted : February 12, 2016
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Oxurion ( ThromboGenics )

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).

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Posterior Vitreous Detachment Disease Progression Drug: ocriplasmin 0.0625mg Drug: ocriplasmin 0.125mg Drug: Sham injection Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : December 2015
Actual Primary Completion Date : November 18, 2019
Actual Study Completion Date : November 18, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ocriplasmin

Arm Intervention/treatment
Experimental: Ocriplasmin 0.0625mg Drug: ocriplasmin 0.0625mg
Up to 3 intravitreal injections of ocriplasmin 0.0625mg approximately 1 month apart

Experimental: Ocriplasmin 0.125mg Drug: ocriplasmin 0.125mg
Up to 3 intravitreal injections of ocriplasmin 0.125mg approximately 1 month apart

Sham Comparator: Sham injection Drug: Sham injection
3 sham injections approximately 1 month apart. No actual injections. No medication is used.




Primary Outcome Measures :
  1. Proportion 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


Secondary Outcome Measures :
  1. Ocular treatment-emergent adverse events in the study eye [ Time Frame: From first injection (Day 0) until the end of the study (Month 24) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02681809


Locations
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United States, Arizona
Phoenix, Arizona, United States, 85021
United States, California
Campbell, California, United States, 95008
Irvine, California, United States, 92697
Loma Linda, California, United States, 92354
Santa Ana, California, United States, 92705
United States, South Dakota
Rapid City, South Dakota, United States, 57701
United States, Texas
McAllen, Texas, United States, 78503
San Antonio, Texas, United States, 78240
United States, Virginia
Charlottesville, Virginia, United States, 22903
Czechia
Brno, Czechia, 625 00
Hradec Kralove, Czechia, 500 05
Olomouc, Czechia, 779 00
Pardubice, Czechia, 530 02
Praha 10, Czechia, 100 34
Praha 4, Czechia, 140 00
Zlin, Czechia, 760 01
France
Paris, France, 75475
Germany
Munchen, Bayern, Germany, 80336
Darmstadt, Hessen, Germany, 64297
Leipzig, Sachsen, Germany, 04103
Hungary
Debrecen, Hajdú-Bihar, Hungary, 4032
Budapest, Hungary, 1062
Budapest, Hungary, 1083
Budapest, Hungary, 1106
Budapest, Hungary, 1133
Szombathely, Hungary, 9700
Israel
Be'er Sheva', Israel, 84101
Petah Tiqva, Israel, 4941492
Rehovot, Israel, 7610001
Tel Aviv, Israel, 6423906
Italy
Milan, Italy, 20132
Spain
Barcelona, Spain, 08195
Barcelona, Spain, 8025
Girona, Spain, 17007
Valladolid, Spain, 47012
United Kingdom
Frimley, Surrey, United Kingdom, GU16 7UJ
London, United Kingdom, EC1V 2PD
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
ThromboGenics
Investigators
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Study Director: Clinical Department ThromboGenics
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Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT02681809    
Other Study ID Numbers: TG-MV-015
2015-002415-15 ( EudraCT Number )
First Posted: February 12, 2016    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Vitreous Detachment
Disease Progression
Disease Attributes
Pathologic Processes
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Fibrinolysin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action