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

December 8, 2020 updated by: ThromboGenics

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)

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).

Study Overview

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • 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
      • Paris, France, 75475
    • Bayern
      • Munchen, Bayern, Germany, 80336
    • Hessen
      • Darmstadt, Hessen, Germany, 64297
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
      • Budapest, Hungary, 1083
      • Budapest, Hungary, 1062
      • Budapest, Hungary, 1106
      • Budapest, Hungary, 1133
      • Szombathely, Hungary, 9700
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 4032
      • Be'er Sheva', Israel, 84101
      • Petah Tiqva, Israel, 4941492
      • Rehovot, Israel, 7610001
      • Tel Aviv, Israel, 6423906
      • Milan, Italy, 20132
      • Barcelona, Spain, 08195
      • Barcelona, Spain, 8025
      • Girona, Spain, 17007
      • Valladolid, Spain, 47012
      • London, United Kingdom, EC1V 2PD
      • London, United Kingdom, SE5 9RS
    • Surrey
      • Frimley, Surrey, United Kingdom, GU16 7UJ
    • Arizona
      • Phoenix, Arizona, United States, 85021
    • California
      • Campbell, California, United States, 95008
      • Irvine, California, United States, 92697
      • Loma Linda, California, United States, 92354
      • Santa Ana, California, United States, 92705
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
    • Texas
      • McAllen, Texas, United States, 78503
      • San Antonio, Texas, United States, 78240
    • Virginia
      • Charlottesville, Virginia, United States, 22903

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ocriplasmin 0.0625mg
Up to 3 intravitreal injections of ocriplasmin 0.0625mg approximately 1 month apart
Experimental: Ocriplasmin 0.125mg
Up to 3 intravitreal injections of ocriplasmin 0.125mg approximately 1 month apart
Sham Comparator: Sham injection
3 sham injections approximately 1 month apart. No actual injections. No medication is used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number 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
Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With Ocular Treatment-emergent Adverse Events in the Study Eye
Time Frame: From first injection until the end of the study (Month 24)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Clinical Department, ThromboGenics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

November 18, 2019

Study Completion (Actual)

November 18, 2019

Study Registration Dates

First Submitted

February 5, 2016

First Submitted That Met QC Criteria

February 9, 2016

First Posted (Estimate)

February 12, 2016

Study Record Updates

Last Update Posted (Actual)

December 16, 2020

Last Update Submitted That Met QC Criteria

December 8, 2020

Last Verified

December 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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