EUCTR2017-003897-15-FRActive, not recruitingPhase 1
A Phase 2, randomised, single-masked, active-controlled, multicentre study to evaluate the efficacy and safety of intravitreal THR-317 administered in combination with ranibizumab, for the treatment of diabetic macular oedema (DME)
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Oxurion NV
- Enrollment
- 72
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility 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® 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
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
Investigators
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