Diabetic Macular Oedema (DME) MedDRA version: 20.1 Level: LLT Classification code 10057915 Term: Diabetic macular oedema System Organ Class: 100000004853 MedDRA version: 20.1 Level: LLT Classification code 10057934 Term: Diabetic macular edema System Organ Class: 100000004853
Conditions
Sponsors
Oxurion NV
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 0.13mg (selected dose level from Part A) and aflibercept in terms of increase in best corrected visual acuity (BCVA) from Baseline at Month 3. ;Secondary Objective: - To assess the efficacy of 3 monthly intravitreal injections of THR-149 over-time - To assess the safety of 3 monthly intravitreal injections of THR-149 over-time - To assess the efficacy and safety of a single flip-over injection (aflibercept or THR 149) when administered 1 month after 3 monthly injections of THR-149 or aflibercept;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Mean change in BCVA ETDRS letter score from Baseline, by study visit • Mean change in CST from Baseline, based on SD-OCT, as assessed by the CRC, by study visit • 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 | — |
Countries
Czechia, France, Germany, Italy, Slovakia, Spain, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Development
Oxurion NV
Outcome results
None listed