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

Phase 2

Completed

• Conditions: Diabetic Retinopathy; Macular Edema; Diabetes Mellitus
• Interventions: Drug: Ranibizumab 0.5mg; Drug: THR-317 8mg; Drug: Sham injection

• Registration Number: NCT03499223
• Lead Sponsor: Oxurion

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-04
• Study First Submitted QC: 2018-04-11
• Study First Posted: 2018-04-17
• Study Start: 2018-04-20
• Primary Completion: 2019-07-18
• Study Completion: 2019-07-18
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-01
• Last Update Posted: 2019-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham + ranibizumab	Ranibizumab 0.5mg	Subjects will receive a sham injection in combination with intravitreal ranibizumab
Ranibizumab + THR-317	THR-317 8mg	Subjects will receive intravitreal ranibizumab in combination with THR-317
Ranibizumab + THR-317	Ranibizumab 0.5mg	Subjects will receive intravitreal ranibizumab in combination with THR-317
Sham + ranibizumab	Sham injection	Subjects will receive a sham injection in combination with intravitreal ranibizumab

Primary Outcome Measures

Name	Time	Method
Change from baseline in BCVA	At Day 84 (Month 3)

Secondary Outcome Measures

Name	Time	Method
Change from baseline in BCVA, by study visit	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	From Screening to Day 140
Withdrawal from repeat study treatment and reason for withdrawal	At Day 28 and at Day 56	Number of subjects meeting withdrawal criteria from repeat study treatment
Incidence of systemic and ocular adverse events including serious adverse events	From Day 0 to Day 140

Trial Locations

Locations (37)

Centre Rétine Gallien; 🇫🇷 Bordeaux, France

CHU Dijon; 🇫🇷 Dijon, France

Hôpital Privé La Louvière; 🇫🇷 Lille, France

Centre Hospitalier Intercommunal de Créteil; 🇫🇷 Créteil, France

Hôpital de la Croix Rousse; 🇫🇷 Lyon, France

Hôpital Saint-Joseph; 🇫🇷 Marseille, France

Centre Hospitalier Universitaire de Nice, Hôpital Pasteur; 🇫🇷 Nice, France

Hôpital Lariboisière; 🇫🇷 Paris, France

Centre Ophtalmologique de l'Odéon; 🇫🇷 Paris, France

Centre Ophtalmologique Maison Rouge; 🇫🇷 Strasbourg, France

Universitaetsklinikum Dresden; 🇩🇪 Dresden, Germany

Charite Universitaetsmedizin Berlin; 🇩🇪 Berlin, Germany

Universitaetsklinikum Frankfurt; 🇩🇪 Frankfurt am Main, Germany

Philipps-Universität Marburg; 🇩🇪 Marburg, Germany

Universitaetsklinikum Leipzig; 🇩🇪 Leipzig, Germany

Klinikum der Stadt Ludwigshafen am Rhein; 🇩🇪 Ludwigshafen am Rhein, Germany

Univerzitná nemocnica Bratislava, Nemocnica Ružinov; 🇸🇰 Bratislava, Slovakia

Fakultná nemocnica s polikliniku Žilina; 🇸🇰 Žilina, Slovakia

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain

Hospital general de Cataluña; 🇪🇸 Barcelona, Spain

Centro Médico Téknon; 🇪🇸 Barcelona, Spain

Vissum Madrid; 🇪🇸 Madrid, Spain

Hospital Universitari de Bellvitge; 🇪🇸 L'Hospitalet De Llobregat, Spain

Hospital General Universitario de Valencia; 🇪🇸 Valencia, Spain

Oftalvist IMED Valencia; 🇪🇸 Valencia, Spain

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Spain

Royal Surrey County Hospital NHS Foundation Trust; 🇬🇧 Guildford, United Kingdom

Leeds Teaching Hospitals NHS Trust; 🇬🇧 Leeds, United Kingdom

City Hospitals Sunderland NHS Foundation Trust; 🇬🇧 Sunderland, United Kingdom

Moorfields Eye Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom

Kings College Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom

CHU Brugmann; 🇧🇪 Brussels, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium

Univerzitná nemocnica Bratislava, Nemocnica Sv. Cyrila a Metoda; 🇸🇰 Bratislava, Slovakia

Nemocnica Poprad, a.s.; 🇸🇰 Poprad, Slovakia

Fakultná nemocnica Trenčín; 🇸🇰 Trenčín, Slovakia

RétinElysée; 🇨🇭 Lausanne, Switzerland