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Oxurion KALAHARI - Diabetic Macular Edema (DME)

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) (KALAHARI)

Study Description:

Condition or Disease

Intervention / Treatment

Phase

Sponsor

Status

Diabetic Macular Edema

ETHR-149
Eylea

Phase 2

Oxurion

Enrolling

Brief Summary:

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

Criteria

Key Inclusion Criteria:

  • Age 18 and older.
  • 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 neovascularization at the disc in the study eye.
  • Presence of iris neovascularization 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:
Beachwood Office:  Diane Weiss  216-831-5700    •   dew@retina-assoc.com.  
Middleburg Heights Office:  Susan Rath  440-663-0022   •   srath@retina-assoc.com.  

To learn more:
https://clinicaltrials.gov/ct2/show/NCT04527107