A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema
NCT ID: NCT04527107
Last Updated: 2023-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
135 participants
INTERVENTIONAL
2020-07-31
2023-11-22
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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THR-149 dose level 1
THR-149 dose level 1
3 intravitreal injections of THR-149 dose level 1, 1 month apart
THR-149 dose level 2
THR-149 dose level 2
3 intravitreal injections of THR-149 dose level 2, 1 month apart
THR-149 dose level 3
THR-149 dose level 3
3 intravitreal injections of THR-149 dose level 3, 1 month apart
THR-149 + sham
THR-149 0.13mg
3 intravitreal injections of THR-149 0.13mg (selected dose level), 1 month apart, followed after 1 month by a sham (pretend) injection
THR-149 + aflibercept flip-over
THR-149 0.13mg + aflibercept 2mg
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
Aflibercept + THR-149 flip-over
aflibercept 2mg + THR-149 0.13mg
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)
Aflibercept + sham
Aflibercept 2mg
3 intravitreal injections of aflibercept 2mg, 1 month apart, followed after 1 month by a sham (pretend) injection
Interventions
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THR-149 dose level 1
3 intravitreal injections of THR-149 dose level 1, 1 month apart
THR-149 dose level 2
3 intravitreal injections of THR-149 dose level 2, 1 month apart
THR-149 dose level 3
3 intravitreal injections of THR-149 dose level 3, 1 month apart
THR-149 0.13mg
3 intravitreal injections of THR-149 0.13mg (selected dose level), 1 month apart, followed after 1 month by a sham (pretend) injection
THR-149 0.13mg + aflibercept 2mg
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
aflibercept 2mg + THR-149 0.13mg
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)
Aflibercept 2mg
3 intravitreal injections of aflibercept 2mg, 1 month apart, followed after 1 month by a sham (pretend) injection
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Oxurion
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Department
Role: STUDY_DIRECTOR
Oxurion
Locations
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Retinal Research Institute, LLC
Phoenix, Arizona, United States
Retina Associates
Tucson, Arizona, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Salehi Retina Institute Inc.
Huntington Beach, California, United States
Northern California Retina Vitreous Associates Medical Group, Inc.
Mountain View, California, United States
California Retina Consultants
Oxnard, California, United States
Retina Consultants San Diego
Poway, California, United States
Retinal Consultants Medical Group
Sacramento, California, United States
Retina Consultants of Southern Colorado, P.C.
Colorado Springs, Colorado, United States
Blue Ocean Clinical Research
Clearwater, Florida, United States
Fort Lauderdale Eye Institute
Plantation, Florida, United States
MedEye Associates
South Miami, Florida, United States
Center for Retina and Macular Disease
Winter Haven, Florida, United States
Southeast Retina Center
Augusta, Georgia, United States
Marietta Eye Clinic
Marietta, Georgia, United States
University Retina and Macula Associates, PC
Oak Forest, Illinois, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Sierra Eye Associates
Reno, Nevada, United States
Retina-Vitreous Surgeons of Central New York, PC
Liverpool, New York, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Retina Associates of Cleveland, Inc
Cleveland, Ohio, United States
Sterling Vision, P.C. dba Oregon Retina
Eugene, Oregon, United States
Tenneesse Retina
Nashville, Tennessee, United States
Retina Research Institute of Texas
Abilene, Texas, United States
Austin Research Center for Retina
Austin, Texas, United States
Austin Retina Associates
Austin, Texas, United States
Retina Research Center, PLLC
Austin, Texas, United States
Texas Retina Associates
Dallas, Texas, United States
Houston Eye Associates
Houston, Texas, United States
Retina Consultants of Houston, PA
Houston, Texas, United States
Valley Retina Institute, PA
McAllen, Texas, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, United States
Retina Associates of South Texas, P.A.
San Antonio, Texas, United States
Retina Consultants of Texas
San Antonio, Texas, United States
Retina Associates of Utah
Salt Lake City, Utah, United States
Piedmont Eye Center
Lynchburg, Virginia, United States
Wagner Macula & Retina Center
Norfolk, Virginia, United States
WVU Eye Institute
Morgantown, West Virginia, United States
Všeobecná fakultní nemocnice v Praze
Prague, , Czechia
Centre Hospitalier Intercommunal de Créteil
Créteil, , France
CHU de Dijon
Dijon, , France
Hôpital de la Croix Rousse
Lyon, , France
Centre Paradis Monticelli
Marseille, , France
Fondation Rothschild
Paris, , France
Hôpital Lariboisière
Paris, , France
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
Internationale Innovative Ophthalmochirurgie
Düsseldorf, , Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, , Germany
Universitätsmedizin Göttingen
Göttingen, , Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Universitätsklinikum Regensburg
Regensburg, , Germany
IRCCS Ospedale San Raffaele
Milan, , Italy
IRCCS Fondazione G.B. Bietti
Roma, , Italy
Azienda Sanitaria Universitaria Friuli Centrale
Udine, , Italy
Fakultná nemocnica s poliklinikou Žilina
Žilina, , Slovakia
Hospital de la Esperanza
Barcelona, , Spain
Hospital Universitari de Bellvitge
Barcelona, , Spain
Hospital General de Catalunya
Barcelona, , Spain
Hospital Dos de Maig
Barcelona, , Spain
Instituto Clínico Quirúrgico de Oftalmología
Bilbao, , Spain
METAVISIÓN ARRUZAFA, S.L.Clínica de Oftalmología de Córdoba S.L. (Hospital La Arruzafa)
Córdoba, , Spain
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, , Spain
Instituto Oftalmológico Gómez-Ulla
Santiago de Compostela, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Fundación de Oftalmología Médica de la Comunitat Valenciana
Valencia, , Spain
Hospital Universitario Rio Hortega
Valladolid, , Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, , Spain
University Hospitals Bristol NHS Foundation Trust
Bristol, , United Kingdom
Kent and Canterbury Hospital
Canterbury, , United Kingdom
Frimley Health NHS Foundation Trust
Frimley, , United Kingdom
Moorfields Eye Hospital NHS Foundation Trust
London, , United Kingdom
London North West University Healthcare NHS Trust
London, , United Kingdom
King's College Hospital NHS Foundation Trust
London, , United Kingdom
South Tyneside and Sunderland NHS Foundation Trust
Sunderland, , United Kingdom
Mid and South Essex NHS Foundation Trust
Westcliff-on-Sea, , United Kingdom
Countries
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Other Identifiers
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2019-001506-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
THR-149-002
Identifier Type: -
Identifier Source: org_study_id