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

NCT03499223 | Completed Phase 2

• 2 other identifiers: THR-317-0022017-003897-15
• Study Type: interventional
• Target: 70
• Locations: 7 countries
• Sites: 37

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).

Conditions

Diabetes Mellitus; Diabetic Retinopathy; Macular Edema

Outcome Measures

Primary Outcomes (1)

• Change from baseline in BCVA

  At Day 84 (Month 3)

Secondary Outcomes (4)

• Incidence of systemic and ocular adverse events including serious adverse events

  From Day 0 to Day 140

• Change from baseline in BCVA, by study visit

  From Day 0 to Day 140

• 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

• Withdrawal from repeat study treatment and reason for withdrawal

  At Day 28 and at Day 56

Study Arms (2)

Ranibizumab + THR-317

EXPERIMENTAL

Subjects will receive intravitreal ranibizumab in combination with THR-317

Drug: Ranibizumab 0.5mg; Drug: THR-317 8mg

Sham + ranibizumab

ACTIVE COMPARATOR

Subjects will receive a sham injection in combination with intravitreal ranibizumab

Drug: Ranibizumab 0.5mg; Drug: Sham injection

Interventions

Ranibizumab 0.5mg DRUG

3 intravitreal injections of ranibizumab 0.5mg, approximately 1 month apart

Also known as: Lucentis®

Ranibizumab + THR-317; Sham + ranibizumab

THR-317 8mg DRUG

3 intravitreal injections of THR-317 8mg, approximately 1 month apart

Ranibizumab + THR-317

Sham injection DRUG

3 sham injections, approximately 1 month apart. No actual injections. No medication is used.

Sham + ranibizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oxurion: lead

Study Sites (37)

CHU Brugmann

Brussels, 1020, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Centre Rétine Gallien

Bordeaux, 33000, France

Location

Centre Hospitalier Intercommunal de Créteil

Créteil, 94010, France

Location

CHU Dijon

Dijon, 21079, France

Location

Hôpital Privé La Louvière

Lille, 59800, France

Location

Hôpital de la Croix Rousse

Lyon, 69004, France

Location

Hôpital Saint-Joseph

Marseille, 13285, France

Location

Centre Hospitalier Universitaire de Nice, Hôpital Pasteur

Nice, 06001, France

Location

Centre Ophtalmologique de l'Odéon

Paris, 75006, France

Location

Hôpital Lariboisière

Paris, 75475, France

Location

Centre Ophtalmologique Maison Rouge

Strasbourg, 67000, France

Location

Charite Universitaetsmedizin Berlin

Berlin, 12203, Germany

Location

Universitaetsklinikum Dresden

Dresden, 01307, Germany

Location

Universitaetsklinikum Frankfurt

Frankfurt am Main, 60590, Germany

Location

Universitaetsklinikum Leipzig

Leipzig, 04103, Germany

Location

Klinikum der Stadt Ludwigshafen am Rhein

Ludwigshafen am Rhein, 67063, Germany

Location

Philipps-Universität Marburg

Marburg, 35043, Germany

Location

Univerzitná nemocnica Bratislava, Nemocnica Ružinov

Bratislava, 826 06, Slovakia

Location

Univerzitná nemocnica Bratislava, Nemocnica Sv. Cyrila a Metoda

Bratislava, 851 07, Slovakia

Location

Nemocnica Poprad, a.s.

Poprad, 058 01, Slovakia

Location

Fakultná nemocnica Trenčín

Trenčín, 911 71, Slovakia

Location

Fakultná nemocnica s polikliniku Žilina

Žilina, 012 07, Slovakia

Location

Centro Médico Téknon

Barcelona, 08022, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08028, Spain

Location

Hospital general de Cataluña

Barcelona, 08195, Spain

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, 08907, Spain

Location

Vissum Madrid

Madrid, 28002, Spain

Location

Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

Oftalvist IMED Valencia

Valencia, 46100, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

RétinElysée

Lausanne, 1006, Switzerland

Location

Royal Surrey County Hospital NHS Foundation Trust

Guildford, GU2 7XX, United Kingdom

Location

Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

Location

Moorfields Eye Hospital NHS Foundation Trust

London, EC1V 2PD, United Kingdom

Location

Kings College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

City Hospitals Sunderland NHS Foundation Trust

Sunderland, SR2 9HP, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Retinopathy; Macular Edema

Interventions

Ranibizumab; TB-403; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Macular Degeneration; Retinal Degeneration

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 17, 2018
• Study Start: April 20, 2018
• Primary Completion: July 18, 2019
• Study Completion: July 18, 2019
• Last Updated: August 2, 2019

Record last verified: 2019-08

Locations

BE (2); ES (8); FR (10); CH (1); GB (5); SL (5); DE (6)