A study to evaluate THR-687 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: EUCTR2020-000362-42-HU
• Lead Sponsor: Oxurion NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-10
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 303

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
- 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

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 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

Study & Design

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