A Phase 2, randomised, multicentre study to assess the dose level of multiple THR-687 injections and to evaluate the efficacy and safety of THR-687 versus aflibercept for the treatment of diabetic macular oedema (DME) - INTEGRA

Oxurion NV0 个研究点目标入组 303 人开始时间: 2021年8月10日最近更新: 2022年5月30日

试验速览

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•- 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
•- CI-DME with CST = 300µm 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 151
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 152

•- Macular oedema 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 IMPs
•- ETDRS severity level = 61 (Part A), or ETDRS severity level =65 (Part B), on colour fundus photograph, in the study eye
•- Presence of iris neovascularisation in the study eye
•- Previous confounding medications / interventions, or their planned administration during the study
•- 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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