A Study to Evaluate THR-317 and Ranibizumab Combination Treatment for Diabetic Macular Oedema (DME)

August 1, 2019 updated by: Oxurion

A Phase 2, Randomised, Single-masked, Active-controlled, Multicentre Study to Evaluate the Efficacy and Safety of Intravitreal THR-317 Administered in Combination With Ranibizumab, for the Treatment of Diabetic Macular Oedema (DME)

This study is conducted to evaluate the safety of intravitreal THR-317 administered in combination with ranibizumab, and to assess the efficacy of the combination treatment in improving best-corrected visual acuity (BCVA) and reducing central subfield thickness (CST), in subjects with central-involved diabetic macular oedema (CI-DME).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

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

  • Belgium
      • Brussels, Belgium, 1020
        • CHU Brugmann
      • Leuven, Belgium, 3000
        • UZ Leuven
  • France
      • Bordeaux, France, 33000
        • Centre Retine Gallien
      • Créteil, France, 94010
        • Centre Hospitalier Intercommunal de Créteil
      • Dijon, France, 21079
        • CHU Dijon
      • Lille, France, 59800
        • Hopital Prive La Louviere
      • Lyon, France, 69004
        • Hôpital de la Croix Rousse
      • Marseille, France, 13285
        • Hôpital Saint-Joseph
      • Nice, France, 06001
        • Centre Hospitalier Universitaire de Nice, Hôpital Pasteur
      • Paris, France, 75475
        • Hopital Lariboisière
      • Paris, France, 75006
        • Centre Ophtalmologique de L'Odeon
      • Strasbourg, France, 67000
        • Centre Ophtalmologique Maison Rouge
  • Germany
      • Berlin, Germany, 12203
        • Charite Universitaetsmedizin Berlin
      • Dresden, Germany, 01307
        • Universitaetsklinikum Dresden
      • Frankfurt am Main, Germany, 60590
        • Universitaetsklinikum Frankfurt
      • Leipzig, Germany, 04103
        • Universitaetsklinikum Leipzig
      • Ludwigshafen am Rhein, Germany, 67063
        • Klinikum der Stadt Ludwigshafen am Rhein
      • Marburg, Germany, 35043
        • Philipps-Universität Marburg
  • Slovakia
      • Bratislava, Slovakia, 826 06
        • Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
      • Bratislava, Slovakia, 851 07
        • Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda
      • Poprad, Slovakia, 058 01
        • Nemocnica Poprad, a.s.
      • Trenčín, Slovakia, 911 71
        • Fakultna nemocnica Trencin
      • Žilina, Slovakia, 012 07
        • Fakultná nemocnica s polikliniku Žilina
  • Spain
      • Barcelona, Spain, 08028
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08022
        • Centro Médico Teknon
      • Barcelona, Spain, 08195
        • Hospital General de Cataluña
      • L'Hospitalet De Llobregat, Spain, 08907
        • Hospital Universitari de Bellvitge
      • Madrid, Spain, 28002
        • Vissum Madrid
      • Valencia, Spain, 46014
        • Hospital General Universitario de Valencia
      • Valencia, Spain, 46100
        • Oftalvist IMED Valencia
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
  • Switzerland
      • Lausanne, Switzerland, 1006
        • RétinElysée
  • United Kingdom
      • Guildford, United Kingdom, GU2 7XX
        • Royal Surrey County Hospital NHS Foundation Trust
      • Leeds, United Kingdom, LS9 7TF
        • Leeds Teaching Hospitals NHS Trust
      • London, United Kingdom, EC1V 2PD
        • Moorfields Eye Hospital NHS Foundation Trust
      • London, United Kingdom, SE5 9RS
        • Kings College Hospital NHS Foundation Trust
      • Sunderland, United Kingdom, SR2 9HP
        • City Hospitals Sunderland NHS Foundation Trust

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
  • Type 1 or type 2 Diabetes Mellitus
  • CI-DME with central subfield thickness of ≥ 320μm on Spectralis® SD-OCT or ≥ 305μm on non Spectralis SD-OCT, in the study eye
  • Anti-vascular endothelial growth factor (anti-VEGF) treatment naïve study eye, or poor or no response to prior treatment with ranibizumab in the study eye
  • Reduced vision primarily due to DME, with BCVA ≤ 72 and ≥ 23 ETDRS letter score (≤ 20/40 and ≥ 20/320 Snellen equivalent) in the study eye
  • Non-proliferative diabetic retinopathy of any stage in the study eye
  • Written informed consent obtained from the subject prior to screening procedures

Exclusion Criteria:

  • Concurrent disease in the study eye, other than CI-DME, that could compromise BCVA, require medical or surgical intervention during the study period or could confound interpretation of the results
  • Previous confounding treatments / procedures, or their planned / expected use during the study period for up to 30 days after the last administration of study treatment
  • Any active ocular / intraocular infection or inflammation in either eye
  • Aphakic study eye
  • Poorly controlled Diabetes Mellitus
  • Uncontrolled hypertension
  • Pregnant or lactating female, or female of child-bearing potential not utilising an adequate form of contraception, or male of reproductive potential not utilising contraception

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ranibizumab + THR-317
Subjects will receive intravitreal ranibizumab in combination with THR-317
Drug: THR-317 8mg
3 intravitreal injections of THR-317 8mg, approximately 1 month apart
Drug: Ranibizumab 0.5mg
3 intravitreal injections of ranibizumab 0.5mg, approximately 1 month apart
Other Names:
  • Lucentis®
ACTIVE_COMPARATOR: Sham + ranibizumab
Subjects will receive a sham injection in combination with intravitreal ranibizumab
Drug: Ranibizumab 0.5mg
3 intravitreal injections of ranibizumab 0.5mg, approximately 1 month apart
Other Names:
  • Lucentis®
Drug: 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
Time Frame
Change from baseline in BCVA
Time Frame: At Day 84 (Month 3)
At Day 84 (Month 3)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of systemic and ocular adverse events including serious adverse events
Time Frame: From Day 0 to Day 140
From Day 0 to Day 140
Change from baseline in BCVA, by study visit
Time Frame: From Day 0 to Day 140
From Day 0 to Day 140
Change from baseline in CST, based on spectral domain optical coherence tomography (SD-OCT), as assessed by the central reading centre, by study visit
Time Frame: From Screening to Day 140
From Screening to Day 140
Withdrawal from repeat study treatment and reason for withdrawal
Time Frame: At Day 28 and at Day 56
Number of subjects meeting withdrawal criteria from repeat study treatment
At Day 28 and at Day 56

Collaborators and Investigators

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

Sponsor

Oxurion

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 (ACTUAL)

April 20, 2018

Primary Completion (ACTUAL)

July 18, 2019

Study Completion (ACTUAL)

July 18, 2019

Study Registration Dates

First Submitted

April 4, 2018

First Submitted That Met QC Criteria

April 11, 2018

First Posted (ACTUAL)

April 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 2, 2019

Last Update Submitted That Met QC Criteria

August 1, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THR-317-002
  • 2017-003897-15 (EUDRACT_NUMBER)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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