ACTRN12618001308280已完成1 期
A Phase Ib, study of safety and tolerability if Intravitreal Fludrocortisone Acetate (FCA) in patients with Geographic Atrophy (GA)
Eye Co Pty Ltd0 个研究点目标入组 10 人开始时间: 2018年8月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
There were no major adverse events (ocular or systemic) observed with intravitreal fludrocortisone acetate injections, at neither the low nor high doses with the current cohort of patients. There was 1 patient (subject 2) where the GA size increased more in the treated eye compared to the untreated eye. However, this effect was not observed in subjects who received the higher dose of Fludrocortisone. More data is required to assess the efficacy of this medication on GA size and vision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 50 Years 至 o limit（—）
- 性别
- All
入选标准
- •Study population will comprise of patients with Geographic Atrophy(GA) secondary to Age Related Macular Degeneration (AMD) in both eyes with no previous treatment.
- •Unless specified otherwise, ocular specific inclusion criteria apply to the study eye only.
- •1.Willing and able to give consent prior to any specific procedures being performed.
- •2.Male or Female.
- •3.Minimum age 50 years.
- •4.Best corrected visual acuity (BCVA) of 24 letters or better using Early Treatment Diabetic Retinopathy Study (ETDRS) charts (20/320 Snellen equivalent).
- •5.Diagnosis of GA of the macula secondary to AMD in both eyes, confirmed within 14 days prior to dosing by the PI using Fundus Autofluorescence (FAF) images, as well as the following criteria:
- •a.Total GA area must be greater than or equal to 1.9 and less than or equal to 17 mm2 (1 and 7 disc areas (DA) respectively), determined by screening images of FAF.
- •b.If GA is multifocal, at least one focal lesions must be greater than or equal to 1.25 mm2 (0.5 DA).
- •c.GA can be completely visualized on the macula centered image.
- •d.GA must be able to be photographed in its entirety.
- •e.GA must be able to be measured separately from any areas of peripapillary atrophy.
- •f.Presence of any pattern of hyperautofluorescence in the junctional zone of GA. Absence of hyperautofluorescence (i.e. pattern = none) is exclusionary.
- •6.Female subjects must be:
- •a.Women of non-childbearing potential (WONCBP), nursing or
- •b.Women of childbearing potential (WOCBP) with a negative pregnancy test at screening and must agree to use protocol defined methods of contraception for the duration of the study.
- •7.Males with female partners of childbearing potential must agree to use protocol defined methods of contraception and agree to refrain from donating sperm for the duration of the study.
- •8.Willing and able to give informed consent.
- •Note: If both eyes meet the inclusion criteria, the eye with the best visual acuity at the screening visit will be designated as the study eye. If both eyes have the same visual acuity, the right eye will be used as the study eye.
排除标准
- •Ocular specific exclusion criteria apply to the study eye only.
- •1.GA due to causes other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like plaquenil maculopathy.
- •2.Spherical equivalent of the refractive error demonstrating > 6 dioptres of myopia or an axial length of >26 mm.
- •3.Any history of current evidence of exudative (wet) AMD including evidence of retinal pigment epithelium rips or evidence of neovascularization anywhere in the retina based on fluorescein angiogram as assessed by the PI in either eye.
- •4.Retinal disease likely to confound visual performance or be affected by intraocular steroid.
- •5.Any ophthalmologic condition that reduces clarity of the media and that, in the opinion of the investigator interferes with ophthalmologic examination (e.g. advanced cataract or corneal abnormalities).
- •6.Any ophthalmologic condition that prevents adequate imaging of the retina judges by the PI.
- •7.Intraocular surgery (including lens replacement surgery) within 3 months prior to dosing.
- •8.Aphakia or absence of the posterior capsule. Previous violation of the posterior capsule is also excluded unless it occurred as a result of yttrium aluminum garnet (YAG) laser posterior capsulotomy in association with prior posterior chamber intraocular lens implantation and at least 60 days prior to Day 0.
- •9.Any ophthalmologic condition that may require surgery during the study period.
- •10.Uncontrolled glaucoma defined as intraocular pressure >25 mmHg on maximal therapy.
- •11.Any contraindication of IVT injection including current ocular or periocular infection.
- •12.History of uveitis or endophthalmitis.
- •13.History of choroidal neovascularization (CNV) in either eye.
- •14.History of IVT injection at any time.
- •15.Participation in another interventional clinical study, or use of any experimental treatment for AMD or any other investigational new drug within 6 weeks or 5 half-lives of the active (whichever is longer) prior to the start of study treatment. Note: clinical trials solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary.
- •16.Medical or psychiatric conditions that, in the opinion of the investigator, make consistent follow-up over the study period unlikely, or in general a poor medical risk because of other systemic diseases or active uncontrolled infections.
- •17.Any screening laboratory value (haematology, serum chemistry or urinalysis) that in the opinion of the investigator is clinically significant and not suitable for study participation.
- •18.History or current evidence of hypersensitivity to any components of the study medication or fluorescein.
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