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)
2 other identifiers
interventional
135
8 countries
78
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 diabetes-mellitus
Started Jul 2020
Typical duration for phase_2 diabetes-mellitus
78 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 31, 2020
CompletedFirst Submitted
Initial submission to the registry
August 21, 2020
CompletedFirst Posted
Study publicly available on registry
August 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 22, 2023
CompletedNovember 27, 2023
November 1, 2023
3.2 years
August 21, 2020
November 23, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Mean change in best-corrected visual acuity (BCVA) ETDRS letter score from Baseline, in subjects in Part B of the study
At Month 3
Secondary Outcomes (3)
Mean change in BCVA ETDRS letter score from Baseline, by study visit
Up to Month 6
Mean change in central subfield thickness (CST) from Baseline, by study visit
Up to Month 6
Incidence of systemic and ocular adverse events (AEs) and serious adverse events (SAEs)
Up to Month 6
Study Arms (7)
THR-149 dose level 1
EXPERIMENTALTHR-149 dose level 2
EXPERIMENTALTHR-149 dose level 3
EXPERIMENTALTHR-149 + sham
EXPERIMENTALTHR-149 + aflibercept flip-over
EXPERIMENTALAflibercept + THR-149 flip-over
ACTIVE COMPARATORAflibercept + sham
ACTIVE COMPARATORInterventions
3 intravitreal injections of THR-149 dose level 1, 1 month apart
3 intravitreal injections of THR-149 dose level 2, 1 month apart
3 intravitreal injections of THR-149 dose level 3, 1 month apart
3 intravitreal injections of THR-149 0.13mg (selected dose level), 1 month apart, followed after 1 month by a sham (pretend) injection
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
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)
3 intravitreal injections of aflibercept 2mg, 1 month apart, followed after 1 month by a sham (pretend) injection
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oxurionlead
Study Sites (78)
Retinal Research Institute, LLC
Phoenix, Arizona, 85053, United States
Retina Associates
Tucson, Arizona, 85704, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211, United States
Salehi Retina Institute Inc.
Huntington Beach, California, 92647, United States
Northern California Retina Vitreous Associates Medical Group, Inc.
Mountain View, California, 94040, United States
California Retina Consultants
Oxnard, California, 93036, United States
Retina Consultants San Diego
Poway, California, 92064, United States
Retinal Consultants Medical Group
Sacramento, California, 95825, United States
Retina Consultants of Southern Colorado, P.C.
Colorado Springs, Colorado, 80909, United States
Blue Ocean Clinical Research
Clearwater, Florida, 33761, United States
Fort Lauderdale Eye Institute
Plantation, Florida, 33324, United States
MedEye Associates
South Miami, Florida, 33143, United States
Center for Retina and Macular Disease
Winter Haven, Florida, 33880, United States
Southeast Retina Center
Augusta, Georgia, 30909, United States
Marietta Eye Clinic
Marietta, Georgia, 30060, United States
University Retina and Macula Associates, PC
Oak Forest, Illinois, 60452, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740, United States
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Sierra Eye Associates
Reno, Nevada, 89502, United States
Retina-Vitreous Surgeons of Central New York, PC
Liverpool, New York, 13088, United States
Cincinnati Eye Institute
Cincinnati, Ohio, 45242, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Retina Associates of Cleveland, Inc
Cleveland, Ohio, 44122, United States
Sterling Vision, P.C. dba Oregon Retina
Eugene, Oregon, 97401, United States
Tenneesse Retina
Nashville, Tennessee, 37203, United States
Retina Research Institute of Texas
Abilene, Texas, 79606, United States
Austin Research Center for Retina
Austin, Texas, 78705, United States
Austin Retina Associates
Austin, Texas, 78705, United States
Retina Research Center, PLLC
Austin, Texas, 78705, United States
Texas Retina Associates
Dallas, Texas, 75231, United States
Houston Eye Associates
Houston, Texas, 77025, United States
Retina Consultants of Houston, PA
Houston, Texas, 77030, United States
Valley Retina Institute, PA
McAllen, Texas, 78503, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240, United States
Retina Associates of South Texas, P.A.
San Antonio, Texas, 78240, United States
Retina Consultants of Texas
San Antonio, Texas, 78240, United States
Retina Associates of Utah
Salt Lake City, Utah, 27560, United States
Piedmont Eye Center
Lynchburg, Virginia, 24502, United States
Wagner Macula & Retina Center
Norfolk, Virginia, 23502, United States
WVU Eye Institute
Morgantown, West Virginia, 26505, United States
Všeobecná fakultní nemocnice v Praze
Prague, 12800, Czechia
Centre Hospitalier Intercommunal de Créteil
Créteil, 94010, France
CHU de Dijon
Dijon, France
Hôpital de la Croix Rousse
Lyon, France
Centre Paradis Monticelli
Marseille, France
Fondation Rothschild
Paris, 75019, France
Hôpital Lariboisière
Paris, 75475, France
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307, Germany
Internationale Innovative Ophthalmochirurgie
Düsseldorf, 40549, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, 60590, Germany
Universitätsmedizin Göttingen
Göttingen, 37075, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
Universitätsklinikum Regensburg
Regensburg, 93053, Germany
IRCCS Ospedale San Raffaele
Milan, 20132, Italy
IRCCS Fondazione G.B. Bietti
Roma, 00184, Italy
Azienda Sanitaria Universitaria Friuli Centrale
Udine, Italy
Fakultná nemocnica s poliklinikou Žilina
Žilina, 012 07, Slovakia
Hospital de la Esperanza
Barcelona, 08024, Spain
Hospital Universitari de Bellvitge
Barcelona, 08907, Spain
Hospital General de Catalunya
Barcelona, 8195, Spain
Hospital Dos de Maig
Barcelona, Spain
Instituto Clínico Quirúrgico de Oftalmología
Bilbao, 480006, Spain
METAVISIÓN ARRUZAFA, S.L.Clínica de Oftalmología de Córdoba S.L. (Hospital La Arruzafa)
Córdoba, 14012, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, 28222, Spain
Instituto Oftalmológico Gómez-Ulla
Santiago de Compostela, 15706, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Fundación de Oftalmología Médica de la Comunitat Valenciana
Valencia, 46015, Spain
Hospital Universitario Rio Hortega
Valladolid, 47012, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, 50009, Spain
University Hospitals Bristol NHS Foundation Trust
Bristol, BS1 2LX, United Kingdom
Kent and Canterbury Hospital
Canterbury, CT1 3NG, United Kingdom
Frimley Health NHS Foundation Trust
Frimley, GU16 7UJ, United Kingdom
Moorfields Eye Hospital NHS Foundation Trust
London, EC1V 2PD, United Kingdom
London North West University Healthcare NHS Trust
London, NW10 7NS, United Kingdom
King's College Hospital NHS Foundation Trust
London, SE5 9RS, United Kingdom
South Tyneside and Sunderland NHS Foundation Trust
Sunderland, SR2 9HP, United Kingdom
Mid and South Essex NHS Foundation Trust
Westcliff-on-Sea, SS0 ORY, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Department
Oxurion
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2020
First Posted
August 26, 2020
Study Start
July 31, 2020
Primary Completion
September 28, 2023
Study Completion
November 22, 2023
Last Updated
November 27, 2023
Record last verified: 2023-11