- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04527107
A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema (KALAHARI)
A Phase 2, Randomised, Multicentre Study to Assess the Dose Level of Multiple THR-149 Injections and to Evaluate the Efficacy and Safety of THR-149 Versus Aflibercept for the Treatment of Diabetic Macular Oedema (DME)
Part A of the study is conducted to select the THR-149 dose level.
Part B of the study is conducted to assess the efficacy and safety of the selected dose level compared to aflibercept, up to Month 3. As from Month 3, in about half of the subjects, the effect of a single flip-over injection (aflibercept or THR-149) will be evaluated when administered 1 month after the 3 monthly injections of THR-149 or aflibercept. In the other subjects, the durability of 3 monthly injections of THR 149 or aflibercept will be evaluated.
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Global Clinical Development
- Phone Number: +32 (0)16 751 310
- Email: info@oxurion.com
Study Locations
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Praha 2, Czechia, 12800
- Vseobecna fakultni nemocnice v Praze
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Créteil, France, 94010
- Centre Hospitalier Intercommunal de Créteil
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Dijon, France
- CHU de DIJON
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Lyon, France
- Hopital de la Croix Rousse
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Marseille, France
- Centre Paradis Monticelli
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Paris, France, 75019
- Fondation Rothschild
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Paris Cedex 10, France, 75475
- Hôpital Lariboisière
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Dresden, Germany, 01307
- Universitätsklinikum Carl Gustav Carus Dresden
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Düsseldorf, Germany, 40549
- Internationale Innovative Ophthalmochirurgie
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Frankfurt am Main, Germany, 60590
- Universitatsklinikum Frankfurt
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Göttingen, Germany, 37075
- Universitatsmedizin Gottingen
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Hamburg, Germany, 20246
- Universitätsklinikum Hamburg-Eppendorf
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Regensburg, Germany, 93053
- Universitätsklinikum Regensburg
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Milan, Italy, 20132
- IRCCS Ospedale San Raffaele
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Roma, Italy, 00184
- IRCCS Fondazione G.B. Bietti
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Udine, Italy
- Azienda Sanitaria Universitaria Friuli Centrale
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Žilina, Slovakia, 012 07
- Fakultna nemocnica s poliklinikou Zilina
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Barcelona, Spain, 08024
- Hospital de la Esperanza
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Barcelona, Spain, 08907
- Hospital Universitari de Bellvitge
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Barcelona, Spain, 8195
- Hospital General de Catalunya
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Barcelona, Spain
- Hospital Dos de Maig
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Bilbao, Spain, 480006
- Instituto Clinico Quirurgico de Oftalmologia
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Córdoba, Spain, 14012
- METAVISIÓN ARRUZAFA, S.L.Clínica de Oftalmología de Córdoba S.L. (Hospital La Arruzafa)
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Madrid, Spain, 28222
- Hospital Universitario Puerta de Hierro Majadahonda
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Santiago De Compostela, Spain, 15706
- Instituto Oftalmologico Gomez-Ulla
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Sevilla, Spain, 41009
- Hospital Universitario Virgen Macarena
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Valencia, Spain, 46015
- Fundación de Oftalmología Médica de la Comunitat Valenciana
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Valladolid, Spain, 47012
- Hospital Universitario Rio Hortega
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Zaragoza, Spain, 50009
- Hospital Clinico Universitario Lozano Blesa
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Bristol, United Kingdom, BS1 2LX
- University Hospitals Bristol NHS Foundation Trust
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Canterbury, United Kingdom, CT1 3NG
- Kent and Canterbury Hospital
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Frimley, United Kingdom, GU16 7UJ
- Frimley Health NHS Foundation Trust
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London, United Kingdom, EC1V 2PD
- Moorfields Eye Hospital NHS Foundation Trust
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London, United Kingdom, SE5 9RS
- King's College Hospital NHS Foundation Trust
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London, United Kingdom, NW10 7NS
- London North West University Healthcare NHS Trust
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Sunderland, United Kingdom, SR2 9HP
- South Tyneside and Sunderland NHS Foundation Trust
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Westcliff-on-Sea, United Kingdom, SS0 ORY
- Mid and South Essex NHS Foundation Trust
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Arizona
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Phoenix, Arizona, United States, 85053
- Retinal Research Institute, LLC
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Tucson, Arizona, United States, 85704
- Retina Associates
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California
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Beverly Hills, California, United States, 90211
- Retina-Vitreous Associates Medical Group
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Huntington Beach, California, United States, 92647
- Salehi Retina Institute Inc.
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Mountain View, California, United States, 94040
- Northern California Retina Vitreous Associates Medical Group, Inc.
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Oxnard, California, United States, 93036
- California Retina Consultants
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Poway, California, United States, 92064
- Retina Consultants San Diego
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Sacramento, California, United States, 95825
- Retinal Consultants Medical Group
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Colorado
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Colorado Springs, Colorado, United States, 80909
- Retina Consultants of Southern Colorado, P.C.
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Florida
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Clearwater, Florida, United States, 33761
- Blue Ocean Clinical Research
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Plantation, Florida, United States, 33324
- Fort Lauderdale Eye Institute
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South Miami, Florida, United States, 33143
- MedEye Associates
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Winter Haven, Florida, United States, 33880
- Center for Retina and Macular Disease
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Georgia
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Augusta, Georgia, United States, 30909
- Southeast Retina Center
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Marietta, Georgia, United States, 30060
- Marietta Eye Clinic
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Illinois
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Oak Forest, Illinois, United States, 60452
- University Retina and Macula Associates, PC
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Maryland
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Hagerstown, Maryland, United States, 21740
- Cumberland Valley Retina Consultants
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Joslin Diabetes Center
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Hospital
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Nevada
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Reno, Nevada, United States, 89502
- Sierra Eye Associates
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New York
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Liverpool, New York, United States, 13088
- Retina-Vitreous Surgeons of Central New York, PC
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Ohio
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Cincinnati, Ohio, United States, 45242
- Cincinnati Eye Institute
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Cleveland, Ohio, United States, 44106
- University Hospitals Cleveland Medical Center
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Cleveland, Ohio, United States, 44122
- Retina Associates of Cleveland, INC
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Oregon
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Eugene, Oregon, United States, 97401
- Sterling Vision, P.C. dba Oregon Retina
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Tennessee
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Nashville, Tennessee, United States, 37203
- Tenneesse Retina
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Texas
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Abilene, Texas, United States, 79606
- Retina Research Institute of Texas
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Austin, Texas, United States, 78705
- Retina Research Center, PLLC
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Austin, Texas, United States, 78705
- Austin Retina Associates
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Austin, Texas, United States, 78705
- Austin Research Center for Retina
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Dallas, Texas, United States, 75231
- Texas Retina Associates
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Houston, Texas, United States, 77030
- Retina Consultants of Houston, PA
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Houston, Texas, United States, 77025
- Houston Eye Associates
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McAllen, Texas, United States, 78503
- Valley Retina Institute, PA
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San Antonio, Texas, United States, 78240
- Medical Center Ophthalmology Associates
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San Antonio, Texas, United States, 78240
- Retina Consultants of Texas
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San Antonio, Texas, United States, 78240
- Retina Associates of South Texas, P.A.
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Utah
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Salt Lake City, Utah, United States, 27560
- Retina Associates of Utah
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Virginia
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Lynchburg, Virginia, United States, 24502
- Piedmont Eye Center
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Norfolk, Virginia, United States, 23502
- Wagner Macula & Retina Center
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West Virginia
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Morgantown, West Virginia, United States, 26505
- WVU Eye Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Key Inclusion Criteria:
- Written informed consent obtained from the subject prior to screening procedures
- Male or female aged 18 years or older at the time of signing the informed consent
- Type 1 or type 2 diabetes
- BCVA ETDRS letter score ≤ 73 and ≥ 39 in the study eye (for subjects in Part A); BCVA ETDRS letter score ≤ 73 and ≥ 24 in the study eye (for subjects in Part B)
- Central involved DME (CI-DME) with CST of ≥ 320µm in men or ≥ 305µm in women, on spectral domain optical coherence tomography (SD-OCT), in the study eye
- Received ≥ 5 anti-vascular endothelial growth factor (anti-VEGF) injections for the treatment of CI-DME
- BCVA ETDRS letter score ≥ 34 in the fellow eye
Key Exclusion Criteria:
- Macular edema due to causes other than DME in the study eye
- Concurrent disease in the study eye, other than central-involved DME, that could require medical or surgical intervention during the study period or could confound interpretation of the results
- Any condition that could confound the ability to detect the efficacy of the investigational medicinal product
- Previous confounding medications / interventions, or their planned administration
- Presence of neovascularisation at the disc in the study eye
- Presence of iris neovascularisation in the study eye
- Uncontrolled glaucoma in the study eye
- Any active or suspected ocular or periocular infection, or active intraocular inflammation, in either eye
- Untreated Diabetes Mellitus
- Glycated haemoglobin A (HbA1c) > 12%
- Uncontrolled hypertension
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: THR-149 dose level 1
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3 intravitreal injections of THR-149 dose level 1, 1 month apart
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Experimental: THR-149 dose level 2
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3 intravitreal injections of THR-149 dose level 2, 1 month apart
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Experimental: THR-149 dose level 3
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3 intravitreal injections of THR-149 dose level 3, 1 month apart
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Experimental: THR-149 + sham
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3 intravitreal injections of THR-149 0.13mg (selected dose level), 1 month apart, followed after 1 month by a sham (pretend) injection
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Experimental: THR-149 + aflibercept flip-over
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3 intravitreal injections of THR-149 0.13mg (selected dose level), 1 month apart, followed after 1 month by an intravitreal injection of aflibercept 2mg
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Active Comparator: Aflibercept + THR-149 flip-over
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3 intravitreal injections of aflibercept 2mg, 1 month apart, followed after 1 month by an intravitreal injection of THR-149 0.13mg (selected dose level)
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Active Comparator: Aflibercept + sham
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3 intravitreal injections of aflibercept 2mg, 1 month apart, followed after 1 month by a sham (pretend) injection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean change in best-corrected visual acuity (BCVA) ETDRS letter score from Baseline, in subjects in Part B of the study
Time Frame: At Month 3
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At Month 3
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean change in BCVA ETDRS letter score from Baseline, by study visit
Time Frame: Up to Month 6
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Up to Month 6
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Mean change in central subfield thickness (CST) from Baseline, by study visit
Time Frame: Up to Month 6
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Up to Month 6
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Incidence of systemic and ocular adverse events (AEs) and serious adverse events (SAEs)
Time Frame: Up to Month 6
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Up to Month 6
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Clinical Department, Oxurion
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Diabetes Complications
- Diabetes Mellitus
- Retinal Degeneration
- Retinal Diseases
- Macular Degeneration
- Diabetic Retinopathy
- Macular Edema
- Edema
- Physiological Effects of Drugs
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Aflibercept
Other Study ID Numbers
- THR-149-002
- 2019-001506-17 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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