NCT01726075已完成2 期
Neurodegeneration as Early Event in Pathogenesis of Diabetic Retinopathy:Multicentric, Prospective, Ph. II-III,Random.Controlled Trial to Assess Efficacy of Neuroprotective Drugs Administered Topically to Prevent/Arrest Diabetic Retinopathy
BCN Peptides11 个研究点 分布在 7 个国家目标入组 450 人开始时间: 2013年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 11
- 主要终点
- Changes in the Implicit Time assessed by mfERG (IT-mfERG) at month 6, 12, 18 and 24
研究概览
简要总结
To assess whether neuroprotective drugs administered topically (somatostatin and brimonidine) are able to prevent or arrest the development and progression of neurodegenerative changes
详细描述
To assess whether neuroprotective drugs administered topically (somatostatin and brimonidine) are able to prevent or arrest the development and progression of neurodegenerative changes related to diabetic retinopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 diabetes mellitus
- •Diabetes duration ≥ 5 years
- •Aged between 45-75 years-old
- •ETDRS level < 20 (microaneurysms absent) (50% of enrolled patients) Or ETDRS levels 20 or 35 with presence of at least one microaneurysm in Field 2 between the superior and inferior arcades (50% of enrolled patients) in the Study Eye as determined by the Reading Centre.
- •Informed Consent
排除标准
- •Previous laser photocoagulation
- •Other diseases which may induce retinal degeneration (e.g. glaucoma)
- •Subject with a refractive error ≥ ± 5 diopter
- •Inadequate ocular media and/ or pupil dilatation that do not permit good quality fundus photography.
- •Renal failure (creatinine > 1.4 mg/dl)
- •HbA1C > 10 % in the previous 6 months and at Screening
- •Subjects taking somatostatin or brimonidine, for any indication, in the previous 3 months
- •Subject has a condition or is in a situation which may put the subject at significant risk, may confound the study results or may interfere significantly with the patient's participation in the study.
- •Pregnancy or nursing
- •Hypersensitivity to the active substances to be tested or to any of the excipients
- •Subject receiving systemic monoamine oxidase (MAO) inhibitor therapy or antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserin)
研究组 & 干预措施
COLIRIOBCN070660
Experimental
COLIRIOBCN070660 Somatostatin 1mg/mL Eye drops, solution. One drop/eye administered twice a day.
干预措施: COLIRIOBCN070660 (Drug)
Placebo
Placebo Comparator
Placebo Eye drops, solution. One drop/eye administered twice a day.
干预措施: Placebo (Drug)
Brimonidine
Experimental
Brimonidine tartrate 2mg/mL One drop/eye administered twice a day.
干预措施: Brimonidine (Drug)
结局指标
主要结局
Changes in the Implicit Time assessed by mfERG (IT-mfERG) at month 6, 12, 18 and 24
时间窗: month 24
次要结局
- Ganglion Cell Layer (GCL) assessed by SD-OCT at month 12(month 12)
- Retinal Nerve Fiber Layer (RNFL) assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) at month 0(month 0)
- Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 12(month 12)
- Central retinal thickness assessed by SD-OCT at month 24(month 24)
- Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 6(month 6)
- Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 18(month 18)
- Ganglion Cell Layer (GCL) assessed by SD-OCT at month 24(month 24)
- Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 12(month 12)
- Retinal thickness assessed by SD-OCT at month 12(month 12)
- Retinal thickness assessed by SD-OCT at month 24(month 24)
- Central retinal thickness assessed by SD-OCT at month 12(month 12)
- Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 24(month 24)
- Ganglion Cell Layer (GCL) assessed by SD-OCT at month 0(month 0)
- Retinal thickness assessed by SD-OCT at month 0(month 0)
- Central retinal thickness assessed by SD-OCT at month 0(month 0)
- Ganglion Cell Layer (GCL) assessed by SD-OCT at month 6(month 6)
- Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at baseline(baseline)
- Ganglion Cell Layer (GCL) assessed by SD-OCT at month 18(month 18)
- Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 18(month 18)
- Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 24(month 24)
- Central retinal thickness assessed by SD-OCT at month 6(month 6)
- Central retinal thickness assessed by SD-OCT at month 18(month 18)
- Diabetic Retinopathy (DR) severity assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) scale CFP - 30º/35º-7 fields at baseline(baseline)
- DR severity assessed by ETDRS scale CFP - 30º/35º-7 fields at month 24(month 24)
- Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 6(month 6)
- Retinal thickness assessed by SD-OCT at month 6(month 6)
- Retinal thickness assessed by SD-OCT at month 18(month 18)
研究者
研究点 (11)
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