A study to evaluate THR-317 and Lucentis® combination treatment for diabetic macular oedema
- Conditions
- Diabetic macular oedema (DME)MedDRA version: 20.1 Level: LLT Classification code 10057915 Term: Diabetic macular oedema System Organ Class: 100000004853MedDRA version: 20.1 Level: LLT Classification code 10057934 Term: Diabetic macular edema System Organ Class: 100000004853Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2017-003897-15-FR
- Lead Sponsor
- Oxurion NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 72
- Male or female aged 18 years or older
- Type 1 or type 2 diabetes
- CI-DME with central subfield thickness of = 320µm on Spectralis® SD-OCT 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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;Timepoint(s) of evaluation of this end point: Day 84 (Month 3)
- Secondary Outcome Measures
Name Time Method <br> 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<br> - Change from baseline in BCVA, by study visit<br> - Change from baseline in CST, based on SD-OCT, as assessed by the CRC, by study visit<br> - Withdrawal from repeat study treatment and reason for withdrawal<br> ;Timepoint(s) of evaluation of this end point: From first administration of study treatment up to end of study