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 = 78 (Part A) or = 73 and = 39 (both study parts) in the study eye - CI-DME with CST = 300µm in men, or = 285µm in women, measured from the retinal pigment epithelium (RPE) to the internal limiting membrane (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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To assess the difference in treatment effect between THR-687 and aflibercept, in terms of the change from Baseline in BCVA at Month 3, in treatment naïve subjects.;Secondary Objective: - To assess the efficacy of multiple IVT injections of THR-687 over-time. - To assess the safety of multiple IVT injections of THR-687 over-time. ;Primary end point(s): Change from Baseline in BCVA ETDRS letter score;Timepoint(s) of evaluation of this end point: At month 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Weighted average of the change from Baseline in BCVA ETDRS letter score from Day 8 through Month 3 using the trapezoidal rule (AUC) - Change from Baseline in BCVA ETDRS letter score, by study visit - Change from Baseline in CST, based on SD-OCT, as assessed by the CRC, by study visit - Incidence of ocular and non-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, Estonia, Germany, Hungary, India, Israel, Italy, Latvia, Lithuania, Poland, Portugal, Slovakia, Spain, United States
Contacts
Public ContactGlobal Clinical development
Oxurion NV
Outcome results
None listed