EUCTR2006-004292-35-GB进行中（未招募）1 期
A pillot study to examine the safety and efficacy of intravitreal ranubizimab/dexamethasone administration and oral minocycline in addition to Visudyne (verteporfin) photdynamic therapy for subfoveal choroidal neovascularization secondary to age related macular degeneration degeneration: an open label trial. - Combination Therapy for the Treatment of Neovascular AMD
Kings College Hospital NHS Foundation Trust0 个研究点目标入组 20 人开始时间: 2009年1月9日最近更新:
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
- 入组人数
- 20
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
- •1.The patient must be willing to give written informed consent.
- •2. The patient must be able to undertake the necessary tests and treatment and be willing to be followed up.
- •3. Age 50 years or older.
- •4. Clinical diagnosis of AMD.
- •5. Subfoveal CNV on fluorescein angiography.
- •6. Log MAR best corrected visual acuity of 24-73 letters on EDTRS chart
- •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
- •1. Inability to understand or sign consent form.
- •2. The patient has a current medical condition or history of a medical condition that would be likely to preclude scheduled study visits such as unstable angina, dialysis, and active cancer.
- •3. Patient has a current ophthalmic condition or history of an ophthalmic condition that might compromise the assessment of the treatment such as diabetic retinopathy, uveitis, amblyopia, ischaemic optic neuropathy.
- •4. Signs of a myopic retina or refraction of > -8 dioptres in their current or any previous glasses prescription.
- •5. Signs of other retinal conditions that may have caused the CNV such as angioid streaks, choroidal rupture, and old chorio-retinitis.
- •6. Open angle glaucoma.
- •7. At increased risk of developing glaucoma such as having; pigment dispersion syndrome or pseudoexfoliation
- •8. Unable to have a good quality fluorescein angiogram taken e.g. due to head tremor or media opacity.
- •9. Known hypersensitivity to fluorescein or any of the study medications.
- •10. Previous treatment for a retinal detachment.
- •11. Judged by the examining clinician to be at increased risk of retinal detachment due to weaknesses in the peripheral retina.
- •12. Previous photodynamic therapy or other therapy for a CNV including argon laser treatment.
- •13. Patient is currently participating or has participated in a clinical trial that utilized an investigational drug or treatment within 30 days prior to enrolment to this study.
- •14. On anticoagulation therapy such as warfarin, with the exception of aspirin and other anti-platelet therapy.
- •15. Exclusion of women of childbearing potential
- •16. Exclusion of pregnant or lactating women
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