CTRI/2020/11/028931尚未招募未知
A Randomized, Double Masked, Controlled Study of the Efficacy, Safety, and Tolerability of Repeated Intravitreal Administration of Brolucizumab versus Ranibizumab in Subjects with Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO)
V Prasad Eye Institute0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
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
入选标准
- •1. Center-involved macular edema secondary to BRVO with mean retinal thickness 250 microns in the central subfield on OCT
- •2. Adults more than or equal to 18 years of age
- •3. ETDRS BCVA of 20/40 to 20/320 (73 to 24 letters) in the study eye
- •4. Men and women of childbearing potential must be willing to utilize adequate contraception and not become pregnant (or have their partner[s] become
- •pregnant during the full course of the study
- •5. Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures
- •6. Willingness to provide written informed consent
排除标准
- •1. History of vitreoretinal surgery in the study eye or anticipated within the next 12 months following Day 1
- •2. Prior episode or bilateral manifestation of RVO
- •4. Prior panretinal laser photocoagulation or macular laser photocoagulation in the study eye
- •5. BRVO disease duration > 9 months from date of diagnosis
- •6. Decrease in visual acuity due to causes other than BRVO
- •7. Only one functional eye even if that eye is otherwise eligible for the study
- •8. Ocular conditions with a poorer prognosis in the fellow eye than in the study eye
- •9. History or presence of AMD (dry or wet form) that is considered by the investigator to significantly affect central vision, DME, or diabetic retinopathy, defined as eyes of diabetic subjects with more than one microaneurysm outside the area of the vein occlusion (inclusive of both eyes)
- •10. Previous use of intraocular corticosteroids in the study eye or use of periocular corticosteroids in the study eye within the 3 months prior to Day 1
- •11. Previous use of intraocular or periocular corticosteroids in the fellow eye within the 3 months prior to Day 1
- •12. Previous treatment with anti-angiogenic drugs in the study eye
- •13. Previous treatment with anti-angiogenic drugs in the fellow eye within the 3 months prior to Day one
- •14. Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in either the study eye or fellow eye
- •15. Vitreomacular traction or epiretinal membrane in either the study eye or fellow eye evident biomicroscopically or on OCT that is considered by the investigator to significantly affect central vision
- •16. Ocular inflammation (including trace or above) or external ocular inflammation in the study eye
- •17. History of idiopathic or autoimmune uveitis in either eye
- •18. Structural damage to the center of the macula in either the study eye or fellow eye that is likely to preclude improvement in VA following the resolution of macular edema
- •19. Concurrent disease in the study eye that would compromise VA or require medical or surgical intervention during the study period
- •20. Cataract surgery in the study eye within 3 months, yttrium-aluminum-garnet (YAG) laser capsulotomy within the past 2 months, or any other intraocular surgery within the 3 months prior to Day 1
- •21. Aphakia or absence of the posterior capsule in the study eye
- •22. Uncontrolled glaucoma, defined as IOP >= 25mmHg on optimal medical regimen, in either the study eye or fellow eye or previous filtration surgery in either the study eye or fellow eye
- •23. Spherical equivalent of the refractive error in the study eye of more than - 8 diopters myopia (for subjects who have had refractive or cataract surgery in the study eye, preoperative spherical equivalent refractive error of more than - 8 diopters myopia)
- •24. Evidence at examination of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye or current treatment for serious systemic infection
- •25. Any ocular disorders in the study eye that, in the opinion of the Investigator, may confound interpretation of study results
- •26. Uncontrolled hypertension defined as systolic >180 mmHg or >160 mmHg on 2 consecutive measurements or diastolic > 100 mmHg on optimal medical regimen
- •27. Uncontrolled diabet
研究者
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