A Study to Evaluate THR-687 Treatment for Diabetic Macular Oedema.

  • End date
    Aug 17, 2023
  • participants needed
  • sponsor
Updated on 17 November 2021


This study is conducted to select the THR-687 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 Diabetes Mellitus, Diabetic Retinopathy, Diabetic Macular Edema, diabetes mellitus (dm)
Treatment Aflibercept, THR-687 dose level 1, THR-687 dose level 2, THR-687 selected dose level
Clinical Study IdentifierNCT05063734
Last Modified on17 November 2021


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 39 in the study eye
CI-DME with CST of 300m in men (or equivalent in women), measured from RPE to ILM inclusively, on SD-OCT, in the study eye
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 DME, that could require medical or surgical intervention during the study period or could confound interpretation of the results
Any condition in the study eye that could confound the ability to detect the efficacy of the investigational medicinal product
Previous confounding medications / interventions, or their planned administration during the study
Presence of iris neovascularisation in the study eye
Uncontrolled glaucoma in the study eye
Previously received THR-687 or any other experimental therapy for DME, in either eye
Any active or suspected ocular or periocular infection, or active intraocular inflammation, in either eye
Untreated Diabetes
Glycated haemoglobin A (HbA1c) > 12%
Uncontrolled hypertension
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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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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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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