CTRI/2022/02/040121尚未招募未知
Efficacy and safety of intravitreal Brolicizumab in Recalcitrant Diabetic Macular Edema
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.Eyes with recalcitrant diabetic macular edema (recalcitrant edema is defined as persisting macular edema (less than 50 microns decrease) after two consecutive anti-VEGF injections with mean retinal thickness of more than 250 μm in the central subfield on OCT
- •2.Availability of baseline OCT and clinical findings at the time of presentation
- •3.Adults >= 18 years
- •4.ETDRS BCVA of 20/40 to 20/320 (73 to 24 letters) in the study eye
- •5.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
- •6.Willing, committed, and able to return for ALL clinic visits and complete all study- related procedures
- •7.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 of intraocular inflammation
- •3. Decrease in visual acuity due to causes other than DME
- •4. Only one functional eye even if that eye is otherwise eligible for the study
- •5. Ocular conditions with a poorer prognosis in the fellow eye than in the study eye
- •6. History or presence of AMD (dry or wet form) that is considered by the investigator to significantly affect central vision,
- •7. 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
- •8. Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in either the study eye or fellow eye
- •8. History of idiopathic or autoimmune uveitis in either eye
- •9. 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
- •10. 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)
- •11. Evidence at examination of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye or current treatment for serious systemic infection
- •12. Any ocular disorders in the study eye that, in the opinion of the Investigator, may confound interpretation of study results
- •13. Pregnancy or lactation
- •14. History of allergy to fluorescein used in fluorescein angiography
- •15. History of allergy to povidone iodine
- •16. Inability to obtain fundus photographs , fluorescein angiograms and OCT of sufficient quality to be analyzed by the site
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