CTIS2023-505791-30-01招募中1 期
A multicentric, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of COLIRIOBCN070660 administered topically in patients with moderately severe non-proliferative diabetic retinopathy
Bcn Peptides S.A.0 个研究点目标入组 100 人开始时间: 2023年8月29日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Men or women with = 18 years old at the time of signing the informed consent., Diagnosis of diabetes mellitus (type I or type II)., Moderately severe NPDR (ETDRS level 47) in the Study Eye as determined by the Central Reading Centre., BCVA ETDRS letter score in the Study eye of =60 letters (approximate Snellen equivalent of 20/63 or better)., Willing and able to comply with clinic visits and study-related procedures., Provide a signed informed consent.
排除标准
- •Presence of CI-DME or other pathologies involving edema in the study eye, confirmed by evaluation of OCT images measured by the Central Reading Center (CRC) according to the following thresholds for Zeiss Cirrus: - = 290 µm in women - = 305 µm in men, History of YAG capsulotomy in the study eye performed within the last 2 months prior to Screening., History of DME or DR treatment with laser photocoagulation in the study eye or intraocular injections of steroids or anti-VEGF medication in any of the two eyes within the prior 12 months to Screening., Active glaucoma treatment., Patients that change diabetes mellitus treatment (including initiation of insulin treatment) in the last 4 months, or plan to do so along the study., HbA1C > 10.5 % in the previous 6 months and at Screening., Subject with a refractive error = ± 5 diopter in the Study eye., Inadequate ocular media, pupil dilatation or lack of cooperation to obtain CFP, FA and OCT images with sufficient quality., Renal failure, dialysis or history of renal implant., Uncontrolled blood pressure (defined as systolic > 180 mm Hg and/or diastolic > 110 mmHg while patient is sitting)., Somatostatin treatment, for any indication, in the previous 3 months from Screening., Presence of retinal neovascularization in the study eye on clinical exam or by 7-field CFP., Condition or 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., Pregnant or nursing or intending to become pregnant along the study., Hypersensitivity to the active substance to be tested or to any of the excipients., Active systemic monoamine oxidase (MAO) inhibitor therapy or antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserin)., Known allergy to fluorescein dye., Participation in an investigational study within 30 days prior to Screening visit that involved treatment with any drug (excluding vitamins and minerals) or device., Current ASNV (Anterior Segment Neovascularization), vitreous haemorrhage, or tractional retinal detachment in the study eye., Any ocular condition (other than DR) in the study eye that, in the opinion of the investigator, would prevent a visual acuity improvement (e.g., clinical signs of glaucoma, clinically relevant cataract)., Intraocular pressure (IOP) = 22 mm Hg in the study eye., Presence of clinical signs of glaucoma in the study eye., Evidence of active inflammation or infection in either eye, including very frequent and chronic inflammations such as blepharitis and conjunctivitis., History of aphakia in the study eye., History of major ocular surgery in the study eye (cataract/glaucoma/retinal detachment surgery) within prior 6 months from Screening.
研究者
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