EUCTR2015-002415-15-IT进行中（未招募）1 期
A PHASE 2, RANDOMISED, DOUBLE-MASKED, SHAM-CONTROLLED, MULTI-CENTRE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRIPLASMIN IN INDUCING TOTAL POSTERIOR VITREOUS DETACHMENT (PVD) IN SUBJECTS WITH NON-PROLIFERATIVE DIABETIC RETINOPATHY (NPDR) (CIRCLE) - CIRCLE
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
- 48
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
- 性别
- All
入选标准
- •- Male or female aged 18 years or older
- •- BCVA of 65 letters read or greater (Snellen equivalent of 20/50 or better) in the study eye
- •- BCVA of 20 letters read or greater (Snellen equivalent of 20/400 or better) in the fellow eye
- •- Clear ocular media for adequate fundus imaging in the study eye
- •- HbA1c = 12%, as assessed by the central laboratory
- •- Moderate to very severe NPDR as per ETDRS Severity Scale (Levels 43A-53E), based on 7 standard field colour fundus photograph, as assessed by the central reading centre (CRC)
- •- No evidence of total PVD in the study eye, based on both B-scan ultrasound and SD-OCT, as assessed by the B-scan expert reader and the CRC, respectively
- •- Written informed consent obtained from the subject prior to screening procedures
- •- Central subfield thickness ( CST) of =340µm on Spectralis SD-OCT or =320µm on non-Spectralis SD-OCT in the study eye, as assessed by the CRC with or without mild CI-DME
- •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 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •- History of or current ocular condition in the study eye that may interfere with the assessment of the progression to PDR (e.g. exudative AMD, retinal vein occlusion [branch or central vein], uveitis, angioid streaks, histoplasmosis, toxoplasmosis, rhegmatogenous retinal detachment, retinal tear, fibrovascular proliferation, lattice degeneration, macular hole, ocular tumours)
- •- Significant ocular trauma in the study eye within 6 months prior to screening (including corneo scleral laceration, lens subluxation, cryo-retinopexy)
- •- Corneal, lenticular, or ocular media abnormalities in the study eye that preclude observation with the slit lamp or accurate readings with a tonometer
- •- Presence of epiretinal membrane in the study eye, based on SD-OCT, as assessed by the CRC
- •- Presence of foveal ischemia in the study eye, based on fluorescein angiograph, as assessed by the CRC
- •- Presence of pre-retinal or vitreous haemorrhage in the study eye
- •- Presence of iris or angle neovascularisation in the study eye
- •- Any active ocular / intraocular infection or inflammation in either eye (e.g. blepharitis, infectious conjunctivitis, keratitis, scleritis, endophthalmitis, uveitis)
- •- Open angle glaucoma or uncontrolled glaucoma in the study eye (uncontrolled glaucoma is defined as intraocular pressure [IOP] = 26mmHg despite treatment with anti-glaucoma medication)
- •- More than 8D high myopia in the study eye
- •- Aphakic study eye
- •- Previous treatments / procedures in the stydy eye as follows: vitrectomy, PRP and Steroid implants [any time] // Intraocular surgery and Intravitreal and peri-ocular steroids [4 months] // Focal / grid laser photocoagulation and Intravitreal anti-VEGF [1 month] // Topical ocular steroids [1 month] [excluded period period to randomisation]
- •- Uncontrolled hypertension in the opinion of the Investigator (e.g. systolic blood pressure > 160mmHg or diastolic blood pressure > 100mmHg for at least 30 days prior to screening despite antihypertensive treatment, or any finding in the Investigator’s opinion suggesting hypertensive retinopathy)
- •- Pseudoexfoliation, Marfan’s syndrome, phacodonesis or any other finding in the Investigator’s opinion suggesting lens / zonular instability
- •- Current use of or possible need for systemic medications known to be toxic to the lens, retina or optic nerve, including Deferoxamine, Chloroquine / hydroxychloroquine (Plaquenil), Tamoxifen, Phenothiazines and Ethambutol
- •- Known hypersensitivity to ocriplasmin, its excipients or any of the medications that will be used for study procedures (e.g. fluorescein, antibiotics, anaesthetic eye drops, eye drops for pupil dilation)
- •- Pregnant or lactating female, or female of child-bearing potential not utilising an adequate form of contraception, or male of reproductive potential not utilising contraception (where 1 method is barrier at the minimum)
- •- Previous ocriplasmin injection in the study eye
- •- History and / or current evidence of a systemic medical condition or any other reason that may, in the Investigator’s opinion, preclude adherence to the scheduled study visits / assessments and safe participation in the study
- •- Concurrent participation in another clinical study, at any time during the entire study period, in which the subject has been or will be exposed to an investigational or a non investigational product (pharmaceutical product or device)
- •- Use of any investigational, non-registered or off-label product within 30 days prior to screening, or planned
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A STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRIPLASMIN IN INDUCING TOTAL POSTERIOR VITREOUS DETACHMENT IN SUBJECTS WITH NON-PROLIFERATIVE DIABETIC RETINOPATHYModerately severe to very severe non-proliferative diabetic retinopathy (NPDR)MedDRA version: 18.1Level: LLTClassification code 10054109Term: Non-proliferative diabetic retinopathySystem Organ Class: 100000004853EUCTR2015-002415-15-FRThromboGenics NV230