A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema (KALAHARI)

November 23, 2023 updated by: Oxurion

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

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Global Clinical Development
  • Phone Number: +32 (0)16 751 310
  • Email: info@oxurion.com

Study Locations

      • Praha 2, Czechia, 12800
        • Vseobecna fakultni nemocnice v Praze
      • Créteil, France, 94010
        • Centre Hospitalier Intercommunal de Créteil
      • Dijon, France
        • CHU de DIJON
      • Lyon, France
        • Hopital de la Croix Rousse
      • Marseille, France
        • Centre Paradis Monticelli
      • Paris, France, 75019
        • Fondation Rothschild
      • Paris Cedex 10, France, 75475
        • Hôpital Lariboisière
      • Dresden, Germany, 01307
        • Universitätsklinikum Carl Gustav Carus Dresden
      • Düsseldorf, Germany, 40549
        • Internationale Innovative Ophthalmochirurgie
      • Frankfurt am Main, Germany, 60590
        • Universitatsklinikum Frankfurt
      • Göttingen, Germany, 37075
        • Universitatsmedizin Gottingen
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf
      • Regensburg, Germany, 93053
        • Universitätsklinikum Regensburg
      • Milan, Italy, 20132
        • IRCCS Ospedale San Raffaele
      • Roma, Italy, 00184
        • IRCCS Fondazione G.B. Bietti
      • Udine, Italy
        • Azienda Sanitaria Universitaria Friuli Centrale
      • Žilina, Slovakia, 012 07
        • Fakultna nemocnica s poliklinikou Zilina
      • Barcelona, Spain, 08024
        • Hospital de la Esperanza
      • Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge
      • Barcelona, Spain, 8195
        • Hospital General de Catalunya
      • Barcelona, Spain
        • Hospital Dos de Maig
      • Bilbao, Spain, 480006
        • Instituto Clinico Quirurgico de Oftalmologia
      • Córdoba, Spain, 14012
        • METAVISIÓN ARRUZAFA, S.L.Clínica de Oftalmología de Córdoba S.L. (Hospital La Arruzafa)
      • Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro Majadahonda
      • Santiago De Compostela, Spain, 15706
        • Instituto Oftalmologico Gomez-Ulla
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Valencia, Spain, 46015
        • Fundación de Oftalmología Médica de la Comunitat Valenciana
      • Valladolid, Spain, 47012
        • Hospital Universitario Rio Hortega
      • Zaragoza, Spain, 50009
        • Hospital Clinico Universitario Lozano Blesa
      • Bristol, United Kingdom, BS1 2LX
        • University Hospitals Bristol NHS Foundation Trust
      • Canterbury, United Kingdom, CT1 3NG
        • Kent and Canterbury Hospital
      • Frimley, United Kingdom, GU16 7UJ
        • Frimley Health NHS Foundation Trust
      • London, United Kingdom, EC1V 2PD
        • Moorfields Eye Hospital NHS Foundation Trust
      • London, United Kingdom, SE5 9RS
        • King's College Hospital NHS Foundation Trust
      • London, United Kingdom, NW10 7NS
        • London North West University Healthcare NHS Trust
      • Sunderland, United Kingdom, SR2 9HP
        • South Tyneside and Sunderland NHS Foundation Trust
      • Westcliff-on-Sea, United Kingdom, SS0 ORY
        • Mid and South Essex NHS Foundation Trust
    • Arizona
      • Phoenix, Arizona, United States, 85053
        • Retinal Research Institute, LLC
      • Tucson, Arizona, United States, 85704
        • Retina Associates
    • California
      • Beverly Hills, California, United States, 90211
        • Retina-Vitreous Associates Medical Group
      • Huntington Beach, California, United States, 92647
        • Salehi Retina Institute Inc.
      • Mountain View, California, United States, 94040
        • Northern California Retina Vitreous Associates Medical Group, Inc.
      • Oxnard, California, United States, 93036
        • California Retina Consultants
      • Poway, California, United States, 92064
        • Retina Consultants San Diego
      • Sacramento, California, United States, 95825
        • Retinal Consultants Medical Group
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Retina Consultants of Southern Colorado, P.C.
    • Florida
      • Clearwater, Florida, United States, 33761
        • Blue Ocean Clinical Research
      • Plantation, Florida, United States, 33324
        • Fort Lauderdale Eye Institute
      • South Miami, Florida, United States, 33143
        • MedEye Associates
      • Winter Haven, Florida, United States, 33880
        • Center for Retina and Macular Disease
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Southeast Retina Center
      • Marietta, Georgia, United States, 30060
        • Marietta Eye Clinic
    • Illinois
      • Oak Forest, Illinois, United States, 60452
        • University Retina and Macula Associates, PC
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Cumberland Valley Retina Consultants
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Joslin Diabetes Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Nevada
      • Reno, Nevada, United States, 89502
        • Sierra Eye Associates
    • New York
      • Liverpool, New York, United States, 13088
        • Retina-Vitreous Surgeons of Central New York, PC
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Cincinnati Eye Institute
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
      • Cleveland, Ohio, United States, 44122
        • Retina Associates of Cleveland, INC
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Sterling Vision, P.C. dba Oregon Retina
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tenneesse Retina
    • Texas
      • Abilene, Texas, United States, 79606
        • Retina Research Institute of Texas
      • Austin, Texas, United States, 78705
        • Retina Research Center, PLLC
      • Austin, Texas, United States, 78705
        • Austin Retina Associates
      • Austin, Texas, United States, 78705
        • Austin Research Center for Retina
      • Dallas, Texas, United States, 75231
        • Texas Retina Associates
      • Houston, Texas, United States, 77030
        • Retina Consultants of Houston, PA
      • Houston, Texas, United States, 77025
        • Houston Eye Associates
      • McAllen, Texas, United States, 78503
        • Valley Retina Institute, PA
      • San Antonio, Texas, United States, 78240
        • Medical Center Ophthalmology Associates
      • San Antonio, Texas, United States, 78240
        • Retina Consultants of Texas
      • San Antonio, Texas, United States, 78240
        • Retina Associates of South Texas, P.A.
    • Utah
      • Salt Lake City, Utah, United States, 27560
        • Retina Associates of Utah
    • Virginia
      • Lynchburg, Virginia, United States, 24502
        • Piedmont Eye Center
      • Norfolk, Virginia, United States, 23502
        • Wagner Macula & Retina Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • WVU Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: THR-149 dose level 1
3 intravitreal injections of THR-149 dose level 1, 1 month apart
Experimental: THR-149 dose level 2
3 intravitreal injections of THR-149 dose level 2, 1 month apart
Experimental: THR-149 dose level 3
3 intravitreal injections of THR-149 dose level 3, 1 month apart
Experimental: THR-149 + sham
3 intravitreal injections of THR-149 0.13mg (selected dose level), 1 month apart, followed after 1 month by a sham (pretend) injection
Experimental: THR-149 + aflibercept flip-over
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
Active Comparator: Aflibercept + THR-149 flip-over
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)
Active Comparator: Aflibercept + sham
3 intravitreal injections of aflibercept 2mg, 1 month apart, followed after 1 month by a sham (pretend) injection

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
At Month 3

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
Up to Month 6
Mean change in central subfield thickness (CST) from Baseline, by study visit
Time Frame: Up to Month 6
Up to Month 6
Incidence of systemic and ocular adverse events (AEs) and serious adverse events (SAEs)
Time Frame: Up to Month 6
Up to Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Clinical Department, Oxurion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2020

Primary Completion (Actual)

September 28, 2023

Study Completion (Actual)

November 22, 2023

Study Registration Dates

First Submitted

August 21, 2020

First Submitted That Met QC Criteria

August 21, 2020

First Posted (Actual)

August 26, 2020

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 23, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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