A Study to Evaluate THR-317 and Ranibizumab Combination Treatment for Diabetic Macular Oedema (DME)
NCT ID: NCT03499223
Last Updated: 2019-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
70 participants
INTERVENTIONAL
2018-04-20
2019-07-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ranibizumab + THR-317
Subjects will receive intravitreal ranibizumab in combination with THR-317
Ranibizumab 0.5mg
3 intravitreal injections of ranibizumab 0.5mg, approximately 1 month apart
THR-317 8mg
3 intravitreal injections of THR-317 8mg, approximately 1 month apart
Sham + ranibizumab
Subjects will receive a sham injection in combination with intravitreal ranibizumab
Ranibizumab 0.5mg
3 intravitreal injections of ranibizumab 0.5mg, approximately 1 month apart
Sham injection
3 sham injections, approximately 1 month apart. No actual injections. No medication is used.
Interventions
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Ranibizumab 0.5mg
3 intravitreal injections of ranibizumab 0.5mg, approximately 1 month apart
THR-317 8mg
3 intravitreal injections of THR-317 8mg, approximately 1 month apart
Sham injection
3 sham injections, approximately 1 month apart. No actual injections. No medication is used.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Oxurion
INDUSTRY
Responsible Party
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Locations
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CHU Brugmann
Brussels, , Belgium
UZ Leuven
Leuven, , Belgium
Centre Rétine Gallien
Bordeaux, , France
Centre Hospitalier Intercommunal de Créteil
Créteil, , France
CHU Dijon
Dijon, , France
Hôpital Privé La Louvière
Lille, , France
Hôpital de la Croix Rousse
Lyon, , France
Hôpital Saint-Joseph
Marseille, , France
Centre Hospitalier Universitaire de Nice, Hôpital Pasteur
Nice, , France
Centre Ophtalmologique de l'Odéon
Paris, , France
Hôpital Lariboisière
Paris, , France
Centre Ophtalmologique Maison Rouge
Strasbourg, , France
Charite Universitaetsmedizin Berlin
Berlin, , Germany
Universitaetsklinikum Dresden
Dresden, , Germany
Universitaetsklinikum Frankfurt
Frankfurt am Main, , Germany
Universitaetsklinikum Leipzig
Leipzig, , Germany
Klinikum der Stadt Ludwigshafen am Rhein
Ludwigshafen am Rhein, , Germany
Philipps-Universität Marburg
Marburg, , Germany
Univerzitná nemocnica Bratislava, Nemocnica Ružinov
Bratislava, , Slovakia
Univerzitná nemocnica Bratislava, Nemocnica Sv. Cyrila a Metoda
Bratislava, , Slovakia
Nemocnica Poprad, a.s.
Poprad, , Slovakia
Fakultná nemocnica Trenčín
Trenčín, , Slovakia
Fakultná nemocnica s polikliniku Žilina
Žilina, , Slovakia
Centro Médico Téknon
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital general de Cataluña
Barcelona, , Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, , Spain
Vissum Madrid
Madrid, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
Oftalvist IMED Valencia
Valencia, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
RétinElysée
Lausanne, , Switzerland
Royal Surrey County Hospital NHS Foundation Trust
Guildford, , United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
Moorfields Eye Hospital NHS Foundation Trust
London, , United Kingdom
Kings College Hospital NHS Foundation Trust
London, , United Kingdom
City Hospitals Sunderland NHS Foundation Trust
Sunderland, , United Kingdom
Countries
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Other Identifiers
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2017-003897-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
THR-317-002
Identifier Type: -
Identifier Source: org_study_id
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