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

Diabetes Mellitus Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03499223
• Other study ID #: THR-317-002
• Secondary ID: 2017-003897-15
• Status: Completed
• Phase: Phase 2
• Start date: April 20, 2018
• Est. completion date: July 18, 2019

Study information

• Verified date: August 2019
• Source: Oxurion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 18, 2019
• Est. primary completion date: July 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Retinopathy
• Edema
• Macular Edema

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels
Belgium	UZ Leuven	Leuven
France	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
Germany	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
Slovakia	Fakultná nemocnica s polikliniku Žilina	Žilina
Slovakia	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 Trencín	Trencín
Spain	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
Switzerland	RétinElysée	Lausanne
United Kingdom	Royal Surrey County Hospital NHS Foundation Trust	Guildford
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds
United Kingdom	Kings College Hospital NHS Foundation Trust	London
United Kingdom	Moorfields Eye Hospital NHS Foundation Trust	London
United Kingdom	City Hospitals Sunderland NHS Foundation Trust	Sunderland

Sponsors (1)

Lead Sponsor	Collaborator
Oxurion

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Slovakia,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in BCVA		At Day 84 (Month 3)
Secondary	Incidence of systemic and ocular adverse events including serious adverse events		From Day 0 to Day 140
Secondary	Change from baseline in BCVA, by study visit		From Day 0 to Day 140
Secondary	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
Secondary	Withdrawal from repeat study treatment and reason for withdrawal	Number of subjects meeting withdrawal criteria from repeat study treatment	At Day 28 and at Day 56