A study to evaluate THR-149 treatment for diabetic macular oedema
- Conditions
- Diabetic Macular Oedema (DME)MedDRA version: 20.1Level: LLTClassification code 10057915Term: Diabetic macular oedemaSystem Organ Class: 100000004853MedDRA version: 20.1Level: LLTClassification code 10057934Term: Diabetic macular edemaSystem Organ Class: 100000004853Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2019-001506-17-IT
- Lead Sponsor
- OXURION NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 122
• 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 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 61
• 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
- Primary Outcome Measures
Name Time Method Main Objective: The objective of the study is to select the THR-149 dose and to assess the difference in treatment effect between THR-149 and aflibercept in terms of increase in best corrected visual acuity (BCVA) from Baseline at Month 3.<br>;Secondary Objective: • To assess the efficacy of 3 monthly intravitreal injections of THR-149 over-time<br>• To assess the safety of 3 monthly intravitreal injections of THR-149 over-time;Primary end point(s): Mean change in BCVA ETDRS letter score from Baseline, at Month 3;Timepoint(s) of evaluation of this end point: From first administration of study treatment up to end of study
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Mean change in BCVA ETDRS letter score from Baseline, by study visit<br>• Mean change in CST from Baseline, based on SD-OCT, as assessed by the CRC, by study visit<br>• Incidence of systemic and ocular AEs and SAEs, from first injection up to the end of the study;Timepoint(s) of evaluation of this end point: From first administration of study treatment up to end of study