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

Sponsor
Oxurion (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04527107
Collaborator
(none)
122
Enrollment
42
Locations
5
Arms
31
Anticipated Duration (Months)
2.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is conducted to select the THR-149 dose level (Part A of the study) and to assess the efficacy and safety of the selected dose level compared to aflibercept (Part B of the study).

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: THR-149 dose level 1
  • Drug: THR-149 dose level 2
  • Drug: THR-149 dose level 3
  • Drug: Aflibercept
  • Drug: THR-149 selected dose level
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
122 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

Active Comparator: aflibercept

Drug: Aflibercept
3 intravitreal injections of aflibercept 2mg, 1 month apart

Experimental: THR-149 selected dose level

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

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

  • 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 RegensburgRegensburgGermany93053
27IRCCS Ospedale San RaffaeleMilanItaly20132
28IRCCS Fondazione G.B. BiettiRomaItaly00144
29Univerzitná nemocnica Bratislava, Nemocnica RužinovBratislavaSlovakia82606
30Fakultná nemocnica TrenčínTrenčínSlovakia911 71
31Fakultná nemocnica s poliklinikou ŽilinaŽilinaSlovakia012 07
32Hospital de la EsperanzaBarcelonaSpain08024
33Hospital Universitari de BellvitgeBarcelonaSpain08907
34Hospital General de CatalunyaBarcelonaSpain8195
35Instituto Clínico Quirúrgico de OftalmologíaBilbaoSpain480006
36Hospital Universitario Puerta de Hierro MajadahondaMadridSpain28222
37FISABIO-Oftalmología MédicaValenciaSpain46015
38Hospital Universitario Rio HortegaValladolidSpain47012
39Hospital Clínico Universitario Lozano BlesaZaragozaSpain50009
40Frimley Health NHS Foundation TrustFrimleyUnited KingdomGU16 7UJ
41Moorfields Eye Hospital NHS Foundation TrustLondonUnited KingdomEC1V 2PD
42King'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:
Oct 12, 2021
Last Verified:
Oct 1, 2021
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 Oct 12, 2021