EUCTR2009-015559-25-GB进行中（未招募）1 期
Preoperative intravitreal ranibizumab for persistent diabetic vitreous haemorrhage: A randomized, double-masked, controlled study - Vitreous Haemorrhage Study
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
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
- •Inclusion criteria
- •1. Adults (male or female over 18) with Type 1 or Type 2 diabetes mellitus
- •2. Grade 2-4 fundus obscuring diabetic vitreous haemorrhage of at least 2 months duration prior to screening in the study eye
- •3. Subjects who have elected to undergo a therapeutic pars plana vitrectomy to clear persistent diabetic vitreous haemorrhage
- •4. Best corrected visual acuity from 40 letters (using 4 metre ETDRS visual acuity score) to perception of light in the study eye
- •5. Patients able and willing to give written and witnessed informed consent.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria
- •1. The presence of tractional retinal elevation in the study eye, as detected by B mode ocular ultrasound or fundus biomicroscopy.
- •2. Other (non-diabetic) cause of vitreous haemorrhage
- •3. Other (non-diabetic) retinal vasculopathy in the study eye
- •4. Subjects who were listed for vitrectomy for recurrent vitreous haemorrhage alone, and not for persistent vitreous haemorrhage
- •5. Subjects whose planned vitrectomy was to have been combined with cataract surgery
- •6. Prior vitrectomy in the study eye
- •7. Visual acuity worse than 6/96 in the non study eye
- •8. Aphakia in the study eye
- •9. Pregnant (urine dipstick confirmed) or lactating women(women of childbearing potential should be advised to use appropriate contraception for three months following eye injection).
- •10. Those with systemic or ocular contraindications to ranibizumab therapy
- •11. Sickle cell disease. Those with sickle trait may be included if there is no evidence of retinopathy in the non study eye.
- •12. Patients who have had an intravitreal injection of any therapeutic agent in the study eye
- •13. Subjects with active concomitant disease in the study eye, including uveitis and infection
- •14. Subjects with inadequate pupil dilation in the study eye, or other cause of significantly impaired fundus view
- •15. Subjects with potentially visually significant cataract in the study eye
- •16. Subjects who have undergone intraocular surgery in the study eye at least 6 months prior to screening, with the exception of cataract surgery, which must have been at least 2 months prior to screening.
- •17. Subjects who have commenced medications that target haemostasis within 3 months of screening, including antithrombotic, antiplatelet and anticoagulant therapy, or who are likely to commence or alter such medications during the course of the study. Subjects who have commenced treatment with these agents at least 3 months prior to screening, and who are stable on treatment, are eligible for inclusion.
- •18. Current participation in another drug or device clinical trial, or participation in such a clinical trial within the last year
- •19. Patients unable or unwilling to give informed consent
- •20. Patients unable or unwilling to return for follow up over 12 months
- •21. Any other condition or situation that, in the opinion of the investigator, may prevent the patient from complying with the study protocol
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Injections into the eye (drug Lucentis) in diabetic patients in whom no further treatment is currently available in clinic when they have developed swelling of the centre of the macula associated with lack of blood supply.Ischaemic Diabetic Macular OedemaMedDRA version: 14.1Level: LLTClassification code 10057915Term: Diabetic macular oedemaSystem Organ Class: 10015919 - Eye disordersMedDRA version: 14.1Level: PTClassification code 10012689Term: Diabetic retinopathySystem Organ Class: 10015919 - Eye disordersMedDRA version: 14.1Level: PTClassification code 10012688Term: Diabetic retinal oedemaSystem Organ Class: 10015919 - Eye disordersMedDRA version: 14.1Level: LLTClassification code 10057934Term: Diabetic macular edemaSystem Organ Class: 10015919 - Eye disordersMedDRA version: 14.1Level: LLTClassification code 10054372Term: Diabetic retinal edemaSystem Organ Class: 10015919 - Eye disordersMedDRA version: 14.1Level: LLTClassification code 10054109Term: Non-proliferative diabetic retinopathySystem Organ Class: 10015919 - Eye disordersMedDRA version: 14.1Level: PTClassification code 10012661Term: Diabetic eye diseaseSystem Organ Class: 10015919 - Eye disordersMedDRA version: 14.1Level: LLTClassification code 10038925Term: Retinopathy diabeticSystem Organ Class: 10015919 - Eye disordersMedDRA version: 14.1Level: HLGTClassification code 10012653Term: Diabetic complicationsSystem Organ Class: 10014698 - Endocrine disordersMedDRA version: 14.1Level: HLTClassification code 10012657Term: Diabetic complications ophthalmicSystem Organ Class: 10014698 - Endocrine disordersEUCTR2013-000031-27-GBMoorfields Eye Hospital80