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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Creteil
      • Dijon, France, 21079
        • CHU Dijon
      • Lille, France, 59800
        • Hôpital privé La Louvière
      • Lyon, France, 69004
        • Hopital de la croix rousse
      • Marseille, France, 13285
        • Höpital Saint-Joseph
      • Nice, France, 06001
        • Centre Hospitalier Universitaire de Nice, Hôpital Pasteur
      • Paris, France, 75475
        • Hopital Lariboisiere
      • 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 Clínic 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in BCVA
Time Frame: At Day 84 (Month 3)
At Day 84 (Month 3)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 18, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 18, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 2, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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