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

  • STATUS
    Recruiting
  • End date
    Mar 18, 2023
  • participants needed
    122
  • sponsor
    Oxurion
Updated on 13 October 2021
diabetes
edema
vegf
type 2 diabetes mellitus
growth factor
bevacizumab
vascular endothelial growth factor
macular edema
aflibercept
diabetic macular edema
optical coherence tomography
spectral domain optical coherence tomography
sd-oct

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).

Details
Condition Diabetes Mellitus, Diabetic Retinopathy, Diabetes Prevention, Diabetic Macular Edema, Diabetes Mellitus Types I and II, Diabetes (Pediatric), diabetes mellitus (dm)
Treatment Aflibercept, THR-149 dose level 1, THR-149 dose level 2, THR-149 dose level 3, THR-149 selected dose level
Clinical Study IdentifierNCT04527107
SponsorOxurion
Last Modified on13 October 2021

Eligibility

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
Central involved DME (CI-DME) with CST of 320m in men or 305m 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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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