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

Sponsor
Oxurion (Industry)
Overall Status
Completed
CT.gov ID
NCT03499223
Collaborator
(none)
70
Enrollment
37
Locations
2
Arms
14.9
Actual Duration (Months)
1.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Ranibizumab 0.5mg
  • Drug: THR-317 8mg
  • Drug: Sham injection
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Apr 20, 2018
Actual Primary Completion Date :
Jul 18, 2019
Actual Study Completion Date :
Jul 18, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ranibizumab + THR-317

Subjects will receive intravitreal ranibizumab in combination with THR-317

Drug: Ranibizumab 0.5mg
3 intravitreal injections of ranibizumab 0.5mg, approximately 1 month apart
Other Names:
  • Lucentis®

    • Drug: THR-317 8mg
    3 intravitreal injections of THR-317 8mg, approximately 1 month apart
    Active Comparator: Sham + ranibizumab

    Subjects will receive a sham injection in combination with intravitreal ranibizumab

    Drug: Ranibizumab 0.5mg
    3 intravitreal injections of ranibizumab 0.5mg, approximately 1 month apart
    Other Names:
  • Lucentis®

    • Drug: Sham injection
    3 sham injections, approximately 1 month apart. No actual injections. No medication is used.

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in BCVA [At Day 84 (Month 3)]

    Secondary Outcome Measures

    1. Incidence of systemic and ocular adverse events including serious adverse events [From Day 0 to Day 140]

    2. Change from baseline in BCVA, by study visit [From Day 0 to Day 140]

    3. 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]

    4. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Brugmann Brussels Belgium 1020
    2 UZ Leuven Leuven Belgium 3000
    3 Centre Rétine Gallien Bordeaux France 33000
    4 Centre Hospitalier Intercommunal de Créteil Créteil France 94010
    5 CHU Dijon Dijon France 21079
    6 Hôpital Privé La Louvière Lille France 59800
    7 Hôpital de la Croix Rousse Lyon France 69004
    8 Hôpital Saint-Joseph Marseille France 13285
    9 Centre Hospitalier Universitaire de Nice, Hôpital Pasteur Nice France 06001
    10 Centre Ophtalmologique de l'Odéon Paris France 75006
    11 Hôpital Lariboisière Paris France 75475
    12 Centre Ophtalmologique Maison Rouge Strasbourg France 67000
    13 Charite Universitaetsmedizin Berlin Berlin Germany 12203
    14 Universitaetsklinikum Dresden Dresden Germany 01307
    15 Universitaetsklinikum Frankfurt Frankfurt am Main Germany 60590
    16 Universitaetsklinikum Leipzig Leipzig Germany 04103
    17 Klinikum der Stadt Ludwigshafen am Rhein Ludwigshafen am Rhein Germany 67063
    18 Philipps-Universität Marburg Marburg Germany 35043
    19 Univerzitná nemocnica Bratislava, Nemocnica Ružinov Bratislava Slovakia 826 06
    20 Univerzitná nemocnica Bratislava, Nemocnica Sv. Cyrila a Metoda Bratislava Slovakia 851 07
    21 Nemocnica Poprad, a.s. Poprad Slovakia 058 01
    22 Fakultná nemocnica Trenčín Trenčín Slovakia 911 71
    23 Fakultná nemocnica s polikliniku Žilina Žilina Slovakia 012 07
    24 Centro Médico Téknon Barcelona Spain 08022
    25 Hospital Clinic de Barcelona Barcelona Spain 08028
    26 Hospital general de Cataluña Barcelona Spain 08195
    27 Hospital Universitari de Bellvitge L'Hospitalet De Llobregat Spain 08907
    28 Vissum Madrid Madrid Spain 28002
    29 Hospital General Universitario de Valencia Valencia Spain 46014
    30 Oftalvist IMED Valencia Valencia Spain 46100
    31 Hospital Universitario Miguel Servet Zaragoza Spain 50009
    32 RétinElysée Lausanne Switzerland 1006
    33 Royal Surrey County Hospital NHS Foundation Trust Guildford United Kingdom GU2 7XX
    34 Leeds Teaching Hospitals NHS Trust Leeds United Kingdom LS9 7TF
    35 Moorfields Eye Hospital NHS Foundation Trust London United Kingdom EC1V 2PD
    36 Kings College Hospital NHS Foundation Trust London United Kingdom SE5 9RS
    37 City Hospitals Sunderland NHS Foundation Trust Sunderland United Kingdom SR2 9HP

    Sponsors and Collaborators

    • Oxurion

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Oxurion
    ClinicalTrials.gov Identifier:
    NCT03499223
    Other Study ID Numbers:
    • THR-317-002
    • 2017-003897-15
    First Posted:
    Apr 17, 2018
    Last Update Posted:
    Aug 2, 2019
    Last Verified:
    Aug 1, 2019
    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
    Additional relevant MeSH terms:
    Macular Edema
    Diabetic Retinopathy
    Edema
    Ranibizumab

    Study Results

    No Results Posted as of Aug 2, 2019