A study to evaluate THR-687 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
- EUCTR2020-000362-42-PT
- 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
- 303
- 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
- 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
- Primary Outcome Measures
Name Time Method 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.<br>- To assess the safety of multiple IVT injections of THR-687 over-time.<br><br><br>;Primary end point(s): Change from Baseline in BCVA ETDRS letter score;Timepoint(s) of evaluation of this end point: At month 3
- Secondary Outcome Measures
Name Time Method 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)<br>- Change from Baseline in BCVA ETDRS letter score, by study visit<br>- Change from Baseline in CST, based on SD-OCT, as assessed by the CRC, by study visit<br>- 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