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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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