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: - Male or female aged 18 years or older - Type 1 or type 2 diabetes - CI-DME with central subfield thickness of = 320µm on Spectralis® SDOCT or = 305µm on non-Spectralis SD-OCT, in the study eye - Anti-VEGF treatment naïve study eye, or poor or no response to prior treatment with ranibizumab in the study eye - Reduced vision primarily due to DME, with BCVA = 72 and = 23 ETDRS letter score (= 20/40 and = 20/320 Snellen equivalent) in the study eye - Non-proliferative diabetic retinopathy (NPDR) of any stage in the study eye - Written informed consent obtained from the subject prior to screening procedures 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 36 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 36
Exclusion criteria
Exclusion criteria: - Macular oedema due to causes other than DME - Concurrent disease in the study eye, other than CI-DME, that could compromise BCVA, require medical or surgical intervention during the study period or could confound interpretation of the results - Change of the retinal architecture in the centre of the macula of the study eye that is likely to preclude improvement in BCVA following the resolution of DME - Previous treatments / procedures as listed below, or their planned / expected use during the study period for up to 30 days after the last study treatment: * Ranibizumab treatment in the study eye (any time for anti-VEGF naïve subjects; 1 month for subjects with a poor or no response to ranibizumab treatment) * Bevacizumab treatment in the study eye (any time for anti-VEGF naïve subjects; 3 months for subjects with a poor or no response to ranibizumab treatment) * Aflibercept treatment in the study eye (any time) * Intraocular surgery in the study eye (3 months) * Focal / grid laser photocoagulation in the study eye (3 months) * Panretinal laser photocoagulation in the study eye (6 months) * Intraocular or peri-ocular corticosteroids in the study eye (4 months) * Ozurdex® (dexamethasone intravitreal implant) in the study eye (6 months) * Other steroid implant in the study eye (any time) * Systemic anti-VEGF treatment (3 months) * Systemic corticosteroids (3 months) - Aphakic study eye - Uncontrolled glaucoma in the study eye - More than 8D high myopia in the study eye - Any active or suspected periocular / ocular / intraocular infection or inflammation in either eye - Untreated diabetes - Glycated haemoglobin A (HbA1c) > 12% - Uncontrolled hypertension in the opinion of the Investigator - Pregnant or lactating female - Female of child-bearing potential not utilising an adequate form of contraception, or planning to become pregnant or to discontinue contraceptive precautions at any time during the entire study period - Male of reproductive potential not utilising contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Day 84 (Month 3);Main Objective: To evaluate the efficacy and safety of THR-317 administered in combination with ranibizumab, in subjects with central-involved DME (CI-DME);Secondary Objective: Not applicable;Primary end point(s): Change from baseline in BCVA | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: From first administration of study treatment up to end of study; Secondary end point(s): - Incidence of systemic and ocular (serious) adverse events ([S]AEs), from first administration of study treatment up to the end of the study - Change from baseline in BCVA, by study visit - Change from baseline in CST, based on SD-OCT, as assessed by the CRC, by study visit - Withdrawal from repeat study treatment and reason for withdrawal | — |
Countries
Belgium, France, Germany, Slovakia, Spain, Switzerland, United Kingdom
Contacts
Public ContactGlobal Clinical Development
Oxurion NV
Outcome results
None listed