Clinical trial NCT03499223: A Study to Evaluate THR-317 and Ranibizumab Combination Treatment for Diabetic Macular Oedema (DME)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus
Diabetic Retinopathy
Macular Edema
Lead sponsor: Oxurion
Sponsor class: INDUSTRY
First posted: 2018-04-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in BCVA
timeFrame: At Day 84 (Month 3)
Secondary outcomes:
measure: Incidence of systemic and ocular adverse events including serious adverse events
timeFrame: From Day 0 to Day 140
measure: Change from baseline in BCVA, by study visit
timeFrame: From Day 0 to Day 140
measure: Change from baseline in CST, based on spectral domain optical coherence tomography (SD-OCT), as assessed by the central reading centre, by study visit
timeFrame: From Screening to Day 140
measure: Withdrawal from repeat study treatment and reason for withdrawal
timeFrame: At Day 28 and at Day 56
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
city: Leuven
country: Belgium
facility: UZ Leuven
city: Bordeaux
country: France
facility: Centre Rétine Gallien
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal de Créteil
city: Dijon
country: France
facility: CHU Dijon
city: Lille
country: France
facility: Hôpital Privé La Louvière
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: Marseille
country: France
facility: Hôpital Saint-Joseph
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice, Hôpital Pasteur
city: Paris
country: France
facility: Centre Ophtalmologique de l'Odéon
city: Paris
country: France
facility: Hôpital Lariboisière
city: Strasbourg
country: France
facility: Centre Ophtalmologique Maison Rouge
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin
city: Dresden
country: Germany
facility: Universitaetsklinikum Dresden
city: Frankfurt am Main
country: Germany
facility: Universitaetsklinikum Frankfurt
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig
city: Ludwigshafen am Rhein
country: Germany
facility: Klinikum der Stadt Ludwigshafen am Rhein
city: Marburg
country: Germany
facility: Philipps-Universität Marburg
city: Bratislava
country: Slovakia
facility: Univerzitná nemocnica Bratislava, Nemocnica Ružinov
city: Bratislava
country: Slovakia
facility: Univerzitná nemocnica Bratislava, Nemocnica Sv. Cyrila a Metoda
city: Poprad
country: Slovakia
facility: Nemocnica Poprad, a.s.
city: Trenčín
country: Slovakia
facility: Fakultná nemocnica Trenčín
city: Žilina
country: Slovakia
facility: Fakultná nemocnica s polikliniku Žilina
city: Barcelona
country: Spain
facility: Centro Médico Téknon
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital general de Cataluña
city: L'Hospitalet De Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
city: Madrid
country: Spain
facility: Vissum Madrid
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Oftalvist IMED Valencia
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Lausanne
country: Switzerland
facility: RétinElysée
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital NHS Foundation Trust
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
city: London
country: United Kingdom
facility: Moorfields Eye Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Kings College Hospital NHS Foundation Trust
city: Sunderland
country: United Kingdom
facility: City Hospitals Sunderland NHS Foundation Trust
Study officials:
References: