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

Sponsor
Oxurion (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04527107
Collaborator
(none)
126
Enrollment
61
Locations
7
Arms
31
Anticipated Duration (Months)
2.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: THR-149 dose level 1
  • Drug: THR-149 dose level 2
  • Drug: THR-149 dose level 3
  • Drug: THR-149 0.13mg
  • Drug: THR-149 0.13mg + aflibercept 2mg
  • Drug: aflibercept 2mg + THR-149 0.13mg
  • Drug: Aflibercept 2mg
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
126 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Jul 31, 2020
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: THR-149 dose level 1

Drug: THR-149 dose level 1
3 intravitreal injections of THR-149 dose level 1, 1 month apart
Experimental: THR-149 dose level 2

Drug: THR-149 dose level 2
3 intravitreal injections of THR-149 dose level 2, 1 month apart
Experimental: THR-149 dose level 3

Drug: THR-149 dose level 3
3 intravitreal injections of THR-149 dose level 3, 1 month apart
Experimental: THR-149 + sham

Drug: 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
Experimental: THR-149 + aflibercept flip-over

Drug: 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
Active Comparator: Aflibercept + THR-149 flip-over

Drug: 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)
Active Comparator: Aflibercept + sham

Drug: Aflibercept 2mg
3 intravitreal injections of aflibercept 2mg, 1 month apart, followed after 1 month by a sham (pretend) injection

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  1. Mean change in BCVA ETDRS letter score from Baseline, by study visit [Up to Month 6]

  2. Mean change in central subfield thickness (CST) from Baseline, by study visit [Up to Month 6]

  3. Incidence of systemic and ocular adverse events (AEs) and serious adverse events (SAEs) [Up to Month 6]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Retina-Vitreous Associates Medical Group Beverly Hills California United States 90211
2 Salehi Retina Institute Inc. Huntington Beach California United States 92647
3 Northern California Retina Vitreous Associates Medical Group, Inc. Mountain View California United States 94040
4 Retina Consultants San Diego Poway California United States 92064
5 Retinal Consultants Medical Group Sacramento California United States 95825
6 Fort Lauderdale Eye Institute Plantation Florida United States 33324
7 Center for Retina and Macular Disease Winter Haven Florida United States 33880
8 University Retina and Macula Associates, PC Oak Forest Illinois United States 60452
9 Cumberland Valley Retina Consultants Hagerstown Maryland United States 21740
10 Henry Ford Hospital Detroit Michigan United States 48202
11 Sierra Eye Associates Reno Nevada United States 89502
12 Retina-Vitreous Surgeons of Central New York, PC Liverpool New York United States 13088
13 University Hospitals Cleveland Medical Center Cleveland Ohio United States 44106
14 Retina Associates of Cleveland, Inc Cleveland Ohio United States 44122
15 Sterling Vision, P.C. dba Oregon Retina Eugene Oregon United States 97401
16 Retina Research Institute of Texas Abilene Texas United States 79606
17 Retina Research Center, PLLC Austin Texas United States 78705
18 Texas Retina Associates Dallas Texas United States 75231
19 Houston Eye Associates Houston Texas United States 77025
20 Retina Consultants of Houston, PA Houston Texas United States 77030
21 Valley Retina Institute, PA McAllen Texas United States 78503
22 Medical Center Ophthalmology Associates San Antonio Texas United States 78240
23 Retina Consultants of Texas San Antonio Texas United States 78240
24 WVU Eye Institute Morgantown West Virginia United States 26505
25 Axon Clinical Prague Czechia 150 00
26 Všeobecná fakultní nemocnice v Praze Praha 2 Czechia 12800
27 Centre Hospitalier Intercommunal de Créteil Créteil France 94010
28 CHU de Dijon Dijon France
29 Hôpital de la Croix Rousse Lyon France
30 Centre Paradis Monticelli Marseille France
31 Hôpital Lariboisière Paris Cedex 10 France 75475
32 Fondation Rothschild Paris France 75019
33 Universitätsklinikum Carl Gustav Carus Dresden Dresden Germany 01307
34 Internationale Innovative Ophthalmochirurgie Düsseldorf Germany 40549
35 Universitätsklinikum Frankfurt Frankfurt am Main Germany 60590
36 Universitätsmedizin Göttingen Göttingen Germany 37075
37 Universitätsklinikum Hamburg-Eppendorf Hamburg Germany 20246
38 Universitätsklinikum Regensburg Regensburg Germany 93053
39 IRCCS Ospedale San Raffaele Milan Italy 20132
40 Fondazione PTV Policlinico Tor Vergata Roma Italy 00133
41 IRCCS Fondazione G.B. Bietti Roma Italy 00144
42 Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
43 Univerzitná nemocnica Bratislava, Nemocnica Ružinov Bratislava Slovakia 82606
44 Fakultná nemocnica Trenčín Trenčín Slovakia 911 71
45 Fakultná nemocnica s poliklinikou Žilina Žilina Slovakia 012 07
46 Hospital de la Esperanza Barcelona Spain 08024
47 Hospital Universitari de Bellvitge Barcelona Spain 08907
48 Hospital General de Catalunya Barcelona Spain 8195
49 Instituto Clínico Quirúrgico de Oftalmología Bilbao Spain 480006
50 Hospital Universitario Puerta de Hierro Majadahonda Madrid Spain 28222
51 FISABIO-Oftalmología Médica Valencia Spain 46015
52 Hospital Universitario Rio Hortega Valladolid Spain 47012
53 Hospital Clínico Universitario Lozano Blesa Zaragoza Spain 50009
54 University Hospitals Bristol NHS Foundation Trust Bristol United Kingdom BS1 2LX
55 Kent and Canterbury Hospital Canterbury United Kingdom CT1 3NG
56 Frimley Health NHS Foundation Trust Frimley United Kingdom GU16 7UJ
57 Moorfields Eye Hospital NHS Foundation Trust London United Kingdom EC1V 2PD
58 London North West University Healthcare NHS Trust London United Kingdom NW10 7NS
59 King's College Hospital NHS Foundation Trust London United Kingdom SE5 9RS
60 South Tyneside and Sunderland NHS Foundation Trust Sunderland United Kingdom SR2 9HP
61 Mid and South Essex NHS Foundation Trust Westcliff-on-Sea United Kingdom SS0 ORY

Sponsors and Collaborators

  • Oxurion

Investigators

  • Study Director: Clinical Department, Oxurion

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Oxurion
ClinicalTrials.gov Identifier:
NCT04527107
Other Study ID Numbers:
  • THR-149-002
  • 2019-001506-17
First Posted:
Aug 26, 2020
Last Update Posted:
Aug 10, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Macular Edema
Diabetic Retinopathy
Edema
Aflibercept

Study Results

No Results Posted as of Aug 10, 2022