A study to evaluate THR-149 treatment for diabetic macular oedema

Phase 1

• Conditions: Diabetic Macular Oedema (DME); MedDRA version: 20.1Level: LLTClassification code 10057915Term: Diabetic macular oedemaSystem Organ Class: 100000004853; MedDRA version: 20.1Level: LLTClassification code 10057934Term: Diabetic macular edemaSystem Organ Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2019-001506-17-SK
• Lead Sponsor: Oxurion NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-09
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 126

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: Part A = 39; Part B = 24
• CI-DME with CST of = 320µm in men or = 305µm in women, on Spectralis SD-OCT in the study eye
• BCVA ETDRS letter score = 34 in the fellow eye
• Received = 5 anti-VEGF injections for the treatment of CI-DME
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 61
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 63

Exclusion Criteria

• 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 IMP
• Presence of neovascularisation at the disc in the study eye
• Presence of iris neovascularisation in the study eye
• previous confounding medications / interventions, or their planned administration
• Uncontrolled glaucoma in the study eye
• Any active or suspected ocular or periocular infection, or active intraocular inflammation, in either eye
• Previously received THR-149 in either eye
• Untreated diabetes
• Glycated haemoglobin A (HbA1c) > 12%
• Uncontrolled hypertension

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified