EUCTR2017-003897-15-DE进行中（未招募）1 期
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)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Oxurion NV
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- 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
- •- Written informed consent obtained from the subject prior to screening
- •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
排除标准
- •- 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
- •* 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
研究者
相似试验
进行中（未招募）
1 期
A study to evaluate THR-317 and Lucentis® combination treatment for diabetic macular oedemaEUCTR2017-003897-15-GBOxurion NV72
进行中（未招募）
1 期
A study to evaluate THR-317 and Lucentis® combination treatment for diabetic macular oedemaDiabetic 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: 100000004853EUCTR2017-003897-15-BEThromboGenics NV72
进行中（未招募）
1 期
A study to evaluate THR-317 and Lucentis® combination treatment for diabetic macular oedemaDiabetic 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: 100000004853EUCTR2017-003897-15-FROxurion NV72
进行中（未招募）
1 期
A study to evaluate THR-317 and Lucentis® combination treatment for diabetic macular oedemaDiabetic 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: 100000004853EUCTR2017-003897-15-SKOxurion NV72
进行中（未招募）
1 期
A study to evaluate THR-317 and Lucentis® combination treatment for diabetic macular oedemaDiabetic 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: 100000004853EUCTR2017-003897-15-ESThromboGenics NV72