Diabetes Mellitus Clinical Trial
— KALAHARIOfficial 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)
| Verified date | November 2023 |
| Source | Oxurion |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 135 |
| Est. completion date | November 22, 2023 |
| Est. primary completion date | September 28, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Czechia | Všeobecná fakultní nemocnice v Praze | Praha 2 | |
| France | 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 Cedex 10 | |
| Germany | 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 | |
| Italy | IRCCS Ospedale San Raffaele | Milan | |
| Italy | IRCCS Fondazione G.B. Bietti | Roma | |
| Italy | Azienda Sanitaria Universitaria Friuli Centrale | Udine | |
| Slovakia | Fakultná nemocnica s poliklinikou Žilina | Žilina | |
| Spain | Hospital de la Esperanza | Barcelona | |
| Spain | Hospital Dos de Maig | Barcelona | |
| Spain | Hospital General de Catalunya | Barcelona | |
| Spain | Hospital Universitari de Bellvitge | 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 | Sevilla | |
| Spain | Fundación de Oftalmología Médica de la Comunitat Valenciana | Valencia | |
| Spain | Hospital Universitario Rio Hortega | Valladolid | |
| Spain | Hospital Clínico Universitario Lozano Blesa | Zaragoza | |
| United Kingdom | University Hospitals Bristol NHS Foundation Trust | Bristol | |
| United Kingdom | Kent and Canterbury Hospital | Canterbury | |
| United Kingdom | Frimley Health NHS Foundation Trust | Frimley | |
| United Kingdom | King's College Hospital NHS Foundation Trust | London | |
| United Kingdom | London North West University Healthcare NHS Trust | London | |
| United Kingdom | Moorfields Eye 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 States | Retina Research Institute of Texas | Abilene | Texas |
| United States | Southeast Retina Center | Augusta | Georgia |
| 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 | Retina-Vitreous Associates Medical Group | Beverly Hills | California |
| United States | Joslin Diabetes Center | Boston | Massachusetts |
| United States | Cincinnati Eye Institute | Cincinnati | Ohio |
| United States | Blue Ocean Clinical Research | Clearwater | Florida |
| United States | Retina Associates of Cleveland, Inc | Cleveland | Ohio |
| United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
| United States | Retina Consultants of Southern Colorado, P.C. | Colorado Springs | Colorado |
| United States | Texas Retina Associates | Dallas | Texas |
| United States | Henry Ford Hospital | Detroit | Michigan |
| United States | Sterling Vision, P.C. dba Oregon Retina | Eugene | Oregon |
| United States | Cumberland Valley Retina Consultants | Hagerstown | Maryland |
| United States | Houston Eye Associates | Houston | Texas |
| United States | Retina Consultants of Houston, PA | Houston | Texas |
| United States | Salehi Retina Institute Inc. | Huntington Beach | California |
| United States | Retina-Vitreous Surgeons of Central New York, PC | Liverpool | New York |
| United States | Piedmont Eye Center | Lynchburg | Virginia |
| United States | Marietta Eye Clinic | Marietta | Georgia |
| United States | Valley Retina Institute, PA | McAllen | Texas |
| United States | WVU Eye Institute | Morgantown | West Virginia |
| United States | Northern California Retina Vitreous Associates Medical Group, Inc. | Mountain View | California |
| United States | Tenneesse Retina | Nashville | Tennessee |
| United States | Wagner Macula & Retina Center | Norfolk | Virginia |
| United States | University Retina and Macula Associates, PC | Oak Forest | Illinois |
| United States | California Retina Consultants | Oxnard | California |
| United States | Retinal Research Institute, LLC | Phoenix | Arizona |
| United States | Fort Lauderdale Eye Institute | Plantation | Florida |
| United States | Retina Consultants San Diego | Poway | California |
| United States | Sierra Eye Associates | Reno | Nevada |
| United States | Retinal Consultants Medical Group | Sacramento | California |
| United States | Retina Associates of Utah | Salt Lake City | Utah |
| 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 | MedEye Associates | South Miami | Florida |
| United States | Retina Associates | Tucson | Arizona |
| United States | Center for Retina and Macular Disease | Winter Haven | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Oxurion |
United States, Czechia, France, Germany, Italy, Slovakia, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Mean change in BCVA ETDRS letter score from Baseline, by study visit | Up to Month 6 | ||
| Secondary | Mean change in central subfield thickness (CST) from Baseline, by study visit | Up to Month 6 | ||
| Secondary | Incidence of systemic and ocular adverse events (AEs) and serious adverse events (SAEs) | Up to Month 6 |
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