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
48
Locations
7
Arms
31
Anticipated Duration (Months)
2.6
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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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

SiteCityStateCountryPostal Code
1Retina-Vitreous Associates Medical GroupBeverly HillsCaliforniaUnited States90211
2Northern California Retina Vitreous Associates Medical Group, Inc.Mountain ViewCaliforniaUnited States94040
3Retina Consultants San DiegoPowayCaliforniaUnited States92064
4Retinal Consultants Medical GroupSacramentoCaliforniaUnited States95825
5Fort Lauderdale Eye InstitutePlantationFloridaUnited States33324
6Center for Retina and Macular DiseaseWinter HavenFloridaUnited States33880
7Cumberland Valley Retina ConsultantsHagerstownMarylandUnited States21740
8Henry Ford HospitalDetroitMichiganUnited States48202
9Sierra Eye AssociatesRenoNevadaUnited States89502
10Retina-Vitreous Surgeons of Central New York, PCLiverpoolNew YorkUnited States13088
11University Hospitals Cleveland Medical CenterClevelandOhioUnited States44106
12Retina Associates of Cleveland, IncClevelandOhioUnited States44122
13Sterling Vision, P.C. dba Oregon RetinaEugeneOregonUnited States97401
14Retina Research Institute of TexasAbileneTexasUnited States79606
15Retina Research Center, PLLCAustinTexasUnited States78705
16Texas Retina AssociatesDallasTexasUnited States75231
17Houston Eye AssociatesHoustonTexasUnited States77025
18Retina Consultants of Houston, PAHoustonTexasUnited States77030
19Valley Retina Institute, PAMcAllenTexasUnited States78503
20Medical Center Ophthalmology AssociatesSan AntonioTexasUnited States78240
21WVU Eye InstituteMorgantownWest VirginiaUnited States26505
22Axon ClinicalPragueCzechia150 00
23Všeobecná fakultní nemocnice v PrazePraha 2Czechia12800
24Universitätsklinikum Carl Gustav Carus DresdenDresdenGermany01307
25Internationale Innovative OphthalmochirurgieDüsseldorfGermany40549
26Universitätsklinikum FrankfurtFrankfurt am MainGermany60590
27Universitätsmedizin GöttingenGöttingenGermany37075
28Universitätsklinikum Hamburg-EppendorfHamburgGermany20246
29Universitätsklinikum RegensburgRegensburgGermany93053
30IRCCS Ospedale San RaffaeleMilanItaly20132
31Fondazione PTV Policlinico Tor VergataRomaItaly00133
32IRCCS Fondazione G.B. BiettiRomaItaly00144
33Univerzitná nemocnica Bratislava, Nemocnica RužinovBratislavaSlovakia82606
34Fakultná nemocnica TrenčínTrenčínSlovakia911 71
35Fakultná nemocnica s poliklinikou ŽilinaŽilinaSlovakia012 07
36Hospital de la EsperanzaBarcelonaSpain08024
37Hospital Universitari de BellvitgeBarcelonaSpain08907
38Hospital General de CatalunyaBarcelonaSpain8195
39Instituto Clínico Quirúrgico de OftalmologíaBilbaoSpain480006
40Hospital Universitario Puerta de Hierro MajadahondaMadridSpain28222
41FISABIO-Oftalmología MédicaValenciaSpain46015
42Hospital Universitario Rio HortegaValladolidSpain47012
43Hospital Clínico Universitario Lozano BlesaZaragozaSpain50009
44University Hospitals Bristol NHS Foundation TrustBristolUnited KingdomBS1 2LX
45Frimley Health NHS Foundation TrustFrimleyUnited KingdomGU16 7UJ
46Moorfields Eye Hospital NHS Foundation TrustLondonUnited KingdomEC1V 2PD
47London North West University Healthcare NHS TrustLondonUnited KingdomNW10 7NS
48King's College Hospital NHS Foundation TrustLondonUnited KingdomSE5 9RS

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:
Feb 24, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 24, 2022