Clinical trial NCT04527107: A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus
Diabetic Retinopathy
Diabetic Macular Edema
Lead sponsor: Oxurion
Sponsor class: INDUSTRY
First posted: 2020-08-26
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean change in best-corrected visual acuity (BCVA) ETDRS letter score from Baseline, in subjects in Part B of the study
timeFrame: At Month 3
Secondary outcomes:
measure: Mean change in BCVA ETDRS letter score from Baseline, by study visit
timeFrame: Up to Month 6
measure: Mean change in central subfield thickness (CST) from Baseline, by study visit
timeFrame: Up to Month 6
measure: Incidence of systemic and ocular adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Up to Month 6
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retinal Research Institute, LLC
state: Arizona
city: Tucson
country: United States
facility: Retina Associates
state: Arizona
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical Group
state: California
city: Huntington Beach
country: United States
facility: Salehi Retina Institute Inc.
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates Medical Group, Inc.
state: California
city: Oxnard
country: United States
facility: California Retina Consultants
state: California
city: Poway
country: United States
facility: Retina Consultants San Diego
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group
state: California
city: Colorado Springs
country: United States
facility: Retina Consultants of Southern Colorado, P.C.
state: Colorado
city: Clearwater
country: United States
facility: Blue Ocean Clinical Research
state: Florida
city: Plantation
country: United States
facility: Fort Lauderdale Eye Institute
state: Florida
city: South Miami
country: United States
facility: MedEye Associates
state: Florida
city: Winter Haven
country: United States
facility: Center for Retina and Macular Disease
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center
state: Georgia
city: Marietta
country: United States
facility: Marietta Eye Clinic
state: Georgia
city: Oak Forest
country: United States
facility: University Retina and Macula Associates, PC
state: Illinois
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants
state: Maryland
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Liverpool
country: United States
facility: Retina-Vitreous Surgeons of Central New York, PC
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Retina Associates of Cleveland, Inc
state: Ohio
city: Eugene
country: United States
facility: Sterling Vision, P.C. dba Oregon Retina
state: Oregon
city: Nashville
country: United States
facility: Tenneesse Retina
state: Tennessee
city: Abilene
country: United States
facility: Retina Research Institute of Texas
state: Texas
city: Austin
country: United States
facility: Austin Research Center for Retina
state: Texas
city: Austin
country: United States
facility: Austin Retina Associates
state: Texas
city: Austin
country: United States
facility: Retina Research Center, PLLC
state: Texas
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: Houston
country: United States
facility: Retina Consultants of Houston, PA
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institute, PA
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
city: San Antonio
country: United States
facility: Retina Associates of South Texas, P.A.
state: Texas
city: San Antonio
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Salt Lake City
country: United States
facility: Retina Associates of Utah
state: Utah
city: Lynchburg
country: United States
facility: Piedmont Eye Center
state: Virginia
city: Norfolk
country: United States
facility: Wagner Macula & Retina Center
state: Virginia
city: Morgantown
country: United States
facility: WVU Eye Institute
state: West Virginia
city: Praha 2
country: Czechia
facility: Všeobecná fakultní nemocnice v Praze
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal de Créteil
city: Dijon
country: France
facility: CHU de Dijon
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: Marseille
country: France
facility: Centre Paradis Monticelli
city: Paris Cedex 10
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Fondation Rothschild
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus Dresden
city: Düsseldorf
country: Germany
facility: Internationale Innovative Ophthalmochirurgie
city: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Roma
country: Italy
facility: IRCCS Fondazione G.B. Bietti
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Friuli Centrale
city: Žilina
country: Slovakia
facility: Fakultná nemocnica s poliklinikou Žilina
city: Barcelona
country: Spain
facility: Hospital de la Esperanza
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Barcelona
country: Spain
facility: Hospital General de Catalunya
city: Barcelona
country: Spain
facility: Hospital Dos de Maig
city: Bilbao
country: Spain
facility: Instituto Clínico Quirúrgico de Oftalmología
city: Córdoba
country: Spain
facility: METAVISIÓN ARRUZAFA, S.L.Clínica de Oftalmología de Córdoba S.L. (Hospital La Arruzafa)
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
city: Santiago De Compostela
country: Spain
facility: Instituto Oftalmológico Gómez-Ulla
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Valencia
country: Spain
facility: Fundación de Oftalmología Médica de la Comunitat Valenciana
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Hortega
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol NHS Foundation Trust
city: Canterbury
country: United Kingdom
facility: Kent and Canterbury Hospital
city: Frimley
country: United Kingdom
facility: Frimley Health NHS Foundation Trust
city: London
country: United Kingdom
facility: Moorfields Eye Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: London North West University Healthcare NHS Trust
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
city: Sunderland
country: United Kingdom
facility: South Tyneside and Sunderland NHS Foundation Trust
city: Westcliff-on-Sea
country: United Kingdom
facility: Mid and South Essex NHS Foundation Trust
Study officials:
affiliation: Oxurion
name: Clinical Department
role: STUDY_DIRECTOR
References: