Back to resultsA Study to Evaluate THR-317 and Ranibizumab Combination Treatment for Diabetic Macular Oedema (DME)
Primary Purpose
Diabetes Mellitus, Diabetic Retinopathy, Macular Edema
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ranibizumab 0.5mg
THR-317 8mg
Sham injection
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus
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
Sites / Locations
- CHU Brugmann
- UZ Leuven
- Centre Rétine Gallien
- Centre Hospitalier Intercommunal de Créteil
- CHU Dijon
- Hôpital Privé La Louvière
- Hôpital de la Croix Rousse
- Hôpital Saint-Joseph
- Centre Hospitalier Universitaire de Nice, Hôpital Pasteur
- Centre Ophtalmologique de l'Odéon
- Hôpital Lariboisière
- Centre Ophtalmologique Maison Rouge
- Charite Universitaetsmedizin Berlin
- Universitaetsklinikum Dresden
- Universitaetsklinikum Frankfurt
- Universitaetsklinikum Leipzig
- Klinikum der Stadt Ludwigshafen am Rhein
- Philipps-Universität Marburg
- Univerzitná nemocnica Bratislava, Nemocnica Ružinov
- Univerzitná nemocnica Bratislava, Nemocnica Sv. Cyrila a Metoda
- Nemocnica Poprad, a.s.
- Fakultná nemocnica Trenčín
- Fakultná nemocnica s polikliniku Žilina
- Centro Médico Téknon
- Hospital Clinic de Barcelona
- Hospital general de Cataluña
- Hospital Universitari de Bellvitge
- Vissum Madrid
- Hospital General Universitario de Valencia
- Oftalvist IMED Valencia
- Hospital Universitario Miguel Servet
- RétinElysée
- Royal Surrey County Hospital NHS Foundation Trust
- Leeds Teaching Hospitals NHS Trust
- Moorfields Eye Hospital NHS Foundation Trust
- Kings College Hospital NHS Foundation Trust
- City Hospitals Sunderland NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ranibizumab + THR-317
Sham + ranibizumab
Arm Description
Subjects will receive intravitreal ranibizumab in combination with THR-317
Subjects will receive a sham injection in combination with intravitreal ranibizumab
Outcomes
Primary Outcome Measures
Change from baseline in BCVA
Secondary Outcome Measures
Incidence of systemic and ocular adverse events including serious adverse events
Change from baseline in BCVA, by study visit
Change from baseline in CST, based on spectral domain optical coherence tomography (SD-OCT), as assessed by the central reading centre, by study visit
Withdrawal from repeat study treatment and reason for withdrawal
Number of subjects meeting withdrawal criteria from repeat study treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03499223
Brief Title
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
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 20, 2018 (Actual)
Primary Completion Date
July 18, 2019 (Actual)
Study Completion Date
July 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oxurion
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Diabetic Retinopathy, Macular Edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ranibizumab + THR-317
Arm Type
Experimental
Arm Description
Subjects will receive intravitreal ranibizumab in combination with THR-317
Arm Title
Sham + ranibizumab
Arm Type
Active Comparator
Arm Description
Subjects will receive a sham injection in combination with intravitreal ranibizumab
Intervention Type
Drug
Intervention Name(s)
Ranibizumab 0.5mg
Other Intervention Name(s)
Lucentis®
Intervention Description
3 intravitreal injections of ranibizumab 0.5mg, approximately 1 month apart
Intervention Type
Drug
Intervention Name(s)
THR-317 8mg
Intervention Description
3 intravitreal injections of THR-317 8mg, approximately 1 month apart
Intervention Type
Drug
Intervention Name(s)
Sham injection
Intervention Description
3 sham injections, approximately 1 month apart. No actual injections. No medication is used.
Primary Outcome Measure Information:
Title
Change from baseline in BCVA
Time Frame
At Day 84 (Month 3)
Secondary Outcome Measure Information:
Title
Incidence of systemic and ocular adverse events including serious adverse events
Time Frame
From Day 0 to Day 140
Title
Change from baseline in BCVA, by study visit
Time Frame
From Day 0 to Day 140
Title
Change from baseline in CST, based on spectral domain optical coherence tomography (SD-OCT), as assessed by the central reading centre, by study visit
Time Frame
From Screening to Day 140
Title
Withdrawal from repeat study treatment and reason for withdrawal
Description
Number of subjects meeting withdrawal criteria from repeat study treatment
Time Frame
At Day 28 and at Day 56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CHU Brugmann
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Centre Rétine Gallien
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Centre Hospitalier Intercommunal de Créteil
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
CHU Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Hôpital Privé La Louvière
City
Lille
ZIP/Postal Code
59800
Country
France
Facility Name
Hôpital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
Hôpital Saint-Joseph
City
Marseille
ZIP/Postal Code
13285
Country
France
Facility Name
Centre Hospitalier Universitaire de Nice, Hôpital Pasteur
City
Nice
ZIP/Postal Code
06001
Country
France
Facility Name
Centre Ophtalmologique de l'Odéon
City
Paris
ZIP/Postal Code
75006
Country
France
Facility Name
Hôpital Lariboisière
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Centre Ophtalmologique Maison Rouge
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Charite Universitaetsmedizin Berlin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Universitaetsklinikum Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitaetsklinikum Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitaetsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Klinikum der Stadt Ludwigshafen am Rhein
City
Ludwigshafen am Rhein
ZIP/Postal Code
67063
Country
Germany
Facility Name
Philipps-Universität Marburg
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Univerzitná nemocnica Bratislava, Nemocnica Ružinov
City
Bratislava
ZIP/Postal Code
826 06
Country
Slovakia
Facility Name
Univerzitná nemocnica Bratislava, Nemocnica Sv. Cyrila a Metoda
City
Bratislava
ZIP/Postal Code
851 07
Country
Slovakia
Facility Name
Nemocnica Poprad, a.s.
City
Poprad
ZIP/Postal Code
058 01
Country
Slovakia
Facility Name
Fakultná nemocnica Trenčín
City
Trenčín
ZIP/Postal Code
911 71
Country
Slovakia
Facility Name
Fakultná nemocnica s polikliniku Žilina
City
Žilina
ZIP/Postal Code
012 07
Country
Slovakia
Facility Name
Centro Médico Téknon
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Hospital general de Cataluña
City
Barcelona
ZIP/Postal Code
08195
Country
Spain
Facility Name
Hospital Universitari de Bellvitge
City
L'Hospitalet De Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Vissum Madrid
City
Madrid
ZIP/Postal Code
28002
Country
Spain
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Oftalvist IMED Valencia
City
Valencia
ZIP/Postal Code
46100
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
RétinElysée
City
Lausanne
ZIP/Postal Code
1006
Country
Switzerland
Facility Name
Royal Surrey County Hospital NHS Foundation Trust
City
Guildford
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Moorfields Eye Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom
Facility Name
Kings College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
City Hospitals Sunderland NHS Foundation Trust
City
Sunderland
ZIP/Postal Code
SR2 9HP
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate THR-317 and Ranibizumab Combination Treatment for Diabetic Macular Oedema (DME)
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