ISRCTN22122298已完成未知
Detection of apoptosing retinal cells in patients with naïve wet age-related macular degeneration as a biomarker for macular atrophy development in patients undergoing anti-VEGF treatment (DAB)
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Adults aged =50 years
- •2. Best corrected visual acuity between 6/12 and 6/96 (30-70 letters)
- •3. Wet AMD established on FAF, optical coherence tomography angiography (OCT-A) and OCT performed at baseline
- •4. Absence of MA as defined per protocol
- •5. Undergoing standard of care wet AMD treatment
- •6. Treatment-naïve (no previous anti-VEGF)
- •7. Sufficiently clear ocular media in the studied eye
- •8. Adequate pupillary dilation
- •9. Fixation to permit quality fundus imaging
- •10. Ability to give informed consent
- •11. The ability to understand and comply with the trial consent process and procedures
- •12. Refractive error not higher than the spherical equivalent of +/-6 D
排除标准
- •1. Previous anti-VEGF treatment
- •2. Geographic atrophy and macular atrophy at baseline as defined per protocol
- •3. Pregnant or lactating, or not using adequate contraception* for the duration of the trial (and 30 days post-injection of study drug)
- •4. Receiving active treatment in any studies of investigational drugs for geographic atrophy (GA)/dry AMD in the study eye
- •5. Co-existing glaucoma, diabetic retinopathy, macular dystrophies, hypertensive retinopathy and other retina conditions, inherited retinal conditions (such as vitelliform macular dystrophy, Stargardt, ADFVM)
- •6. Presence of epiretinal membrane (ERM)
- •7. Any evidence of ocular inflammation
- •8. History of retinal surgery, or other surgical intervention for AMD in the study eye
- •9. Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy in the study eye
- •10. Prior treatment with Visudyne (photodynamic Therapy [PDT]), external-beam radiation therapy, or transpupillary thermotherapy in the study eye
- •11. History of prophylactic subthreshold laser treatment for AMD in the study eye
- •12. Previous intravitreal drug delivery in the study eye (e.g., intravitreal corticosteroid injection, anti-angiogenic drugs, anti-complement agents, or device implantation)
- •13. A single intraoperative administration of a corticosteroid during cataract surgery for cystoid
- •14. Any concurrent ocular or intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could do either of the following:
- •14.1. Require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition
- •14.2. If allowed to progress untreated, could likely contribute to the loss of visual potential in that eye
- •15. Previous violation of the posterior capsule in the study eye unless it occurred as a result of Yttrium Aluminum Garnet (YAG) laser posterior capsulotomy in association with prior posterior chamber intraocular lens implantation. For patients who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye should not have exceeded 6 diopters of myopia.
- •16. Intraocular surgery (including cataract surgery) in the study eye within 3 months preceding Day 1
- •17. History of glaucoma-filtering surgery in the study eye
- •18. History of corneal transplant in the study eye
- •19. Major surgery (major according to the investigator's assessment) performed within 12 weeks prior to randomization or planned within 12 months after screening, e.g. hip replacement
- •20. Currently enrolled in another investigational device or drug trial, or less than 30 days since ending another investigational device or drug trial(s), or receiving other investigational treatment(s)
研究者
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