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

  • End date
    Mar 27, 2023
  • participants needed
  • sponsor
Updated on 27 July 2022
type 2 diabetes mellitus
growth factor
vascular endothelial growth factor
macular edema
diabetic macular edema
optical coherence tomography
spectral domain optical coherence tomography


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 Diabetes Mellitus, Diabetic Retinopathy, Diabetic Macular Edema
Treatment Aflibercept, THR-149 dose level 1, THR-149 dose level 2, THR-149 dose level 3, THR-149 selected dose level, THR-149 0.13mg, THR-149 0.13mg + aflibercept 2mg, aflibercept 2mg + THR-149 0.13mg, Aflibercept 2mg
Clinical Study IdentifierNCT04527107
Last Modified on27 July 2022


Yes No Not Sure

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

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
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