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

Primary Purpose

Diabetic Retinopathy, Posterior Vitreous Detachment, Disease Progression

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ocriplasmin 0.0625mg
ocriplasmin 0.125mg
Sham injection
Sponsored by
ThromboGenics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Retinopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Ocriplasmin 0.0625mg

Ocriplasmin 0.125mg

Sham injection

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 5, 2016
Last Updated
December 8, 2020
Sponsor
ThromboGenics
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1. Study Identification

Unique Protocol Identification Number
NCT02681809
Brief Title
A Study to Evaluate the Efficacy and Safety of Ocriplasmin in Inducing Total PVD in Subjects With NPDR
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment rate
Study Start Date
December 2015 (undefined)
Primary Completion Date
November 18, 2019 (Actual)
Study Completion Date
November 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ThromboGenics

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy, Posterior Vitreous Detachment, Disease Progression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ocriplasmin 0.0625mg
Arm Type
Experimental
Arm Title
Ocriplasmin 0.125mg
Arm Type
Experimental
Arm Title
Sham injection
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
ocriplasmin 0.0625mg
Intervention Description
Up to 3 intravitreal injections of ocriplasmin 0.0625mg approximately 1 month apart
Intervention Type
Drug
Intervention Name(s)
ocriplasmin 0.125mg
Intervention Description
Up to 3 intravitreal injections of ocriplasmin 0.125mg approximately 1 month apart
Intervention Type
Drug
Intervention Name(s)
Sham injection
Intervention Description
3 sham injections approximately 1 month apart. No actual injections. No medication is used.
Primary Outcome Measure Information:
Title
Number of Subjects With Total PVD by the Month 3 Visit
Description
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
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Number of Subjects With Ocular Treatment-emergent Adverse Events in the Study Eye
Description
Adverse events were identified by ophthalmic assessments (including BCVA assessment, full ophthalmic examination and ocular imaging) and by subject reporting
Time Frame
From first injection until the end of the study (Month 24)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Department
Organizational Affiliation
ThromboGenics
Official's Role
Study Director
Facility Information:
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85021
Country
United States
City
Campbell
State/Province
California
ZIP/Postal Code
95008
Country
United States
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
City
Praha 4
ZIP/Postal Code
140 00
Country
Czechia
City
Zlin
ZIP/Postal Code
760 01
Country
Czechia
City
Paris
ZIP/Postal Code
75475
Country
France
City
Munchen
State/Province
Bayern
ZIP/Postal Code
80336
Country
Germany
City
Darmstadt
State/Province
Hessen
ZIP/Postal Code
64297
Country
Germany
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
City
Debrecen
State/Province
Hajdú-Bihar
ZIP/Postal Code
4032
Country
Hungary
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
City
Budapest
ZIP/Postal Code
1133
Country
Hungary
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
City
Be'er Sheva'
ZIP/Postal Code
84101
Country
Israel
City
Petah Tiqva
ZIP/Postal Code
4941492
Country
Israel
City
Rehovot
ZIP/Postal Code
7610001
Country
Israel
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
City
Milan
ZIP/Postal Code
20132
Country
Italy
City
Barcelona
ZIP/Postal Code
08195
Country
Spain
City
Barcelona
ZIP/Postal Code
8025
Country
Spain
City
Girona
ZIP/Postal Code
17007
Country
Spain
City
Valladolid
ZIP/Postal Code
47012
Country
Spain
City
Frimley
State/Province
Surrey
ZIP/Postal Code
GU16 7UJ
Country
United Kingdom
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

12. IPD Sharing Statement

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

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