ACTRN12624000997550尚未招募2 期
A Phase II, Multicentre, 2-part, Study of the Safety, Tolerability, and Efficacy of Intravitreal Fludrocortisone Acetate in Subjects with Geographic Atrophy Secondary to Age-related Macular Degeneration - Part B
EyeCo Pty Ltd0 个研究点目标入组 126 人开始时间: 2024年8月14日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 126
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 50 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.The subject must voluntarily sign and date an informed consent, approved by the HREC, prior to the initiation of any screening or study-specific procedures. A legally authorised representative may be used in case the subject is unable to read due to literacy.
- •2.In the opinion of the Investigator, willing and able to follow study instructions and likely to complete all scheduled study visits.
- •3.Male or female subjects.
- •4.Subjects aged 50 years and over.
- •5.Female subjects must be of nonchildbearing potential or show a negative pregnancy test at screening and must agree to use appropriate methods of contraception during the study.
- •6.Males with female partners of childbearing potential must agree to use appropriate methods of contraception and agree to refrain from donating sperm during the study.
- •7.BCVA of 30 letters or better using Early Treatment Diabetic Retinopathy Study (ETDRS) charts (20/200 Snellen equivalent).
- •8.Diagnosis of GA secondary to AMD, confirmed using FAF within 28 days prior to randomisation, to the following criteria:
- •a.GA defined as a sharply delineated, roughly round or oval area of partial or complete retinal pigment epithelium (RPE) depigmentation, resulting in better visibility of the underlying large choroidal vessels
- •b.Total GA area must be greater than or equal to 1.25mm2 and less than or equal to 17.5 mm2
- •- If GA is multifocal, at least one focal lesion must be greater than or equal to 1.25mm2
- •c.The GA lesion/s must be completely visualised on the macula centred image, able to be imaged in its entirety, and must be able to be measured separately from any areas of peripapillary atrophy
- •d.Presence of any pattern of hyper-autofluorescence in the junctional zone of GA.
- •9.Sufficiently clear ocular media, adequate pupillary dilation, fixation to permit quality fundus imaging, and ability to cooperate for adequate visual function testing and anatomic assessment in the study eye.
排除标准
- •1.GA due to causes other than AMD such as Stargardt disease, cone rod dystrophy, or toxic maculopathies like plaquenil maculopathy.
- •2.Spherical equivalent refractive error of -6.00 diopters of myopia or worse, or an axial length greater than 26 mm.
- •3.Any history, or current evidence of exudative (wet”) AMD; including any evidence of RPE rips or evidence of neovascularisation anywhere in the retina.
- •4.Retinal disease other than AMD; however, benign conditions of the vitreous or peripheral retina are not exclusionary (ie, pavingstone degeneration).
- •5.Any ophthalmologic condition that reduces the clarity of the media and that, in the opinion of the Investigator, interferes with ophthalmologic examination and/or prevents adequate imaging of the retina (e.g. advanced cataract or corneal abnormalities).
- •6.Intraocular surgery (including lens replacement surgery) within 3 months prior to randomisation.
- •7.Aphakia or absence of the posterior capsule
- •- Previous violation of the posterior capsule is also excluded unless it occurred as a result of yttrium aluminium garnet (YAG) laser posterior capsulotomy in association with prior posterior chamber intraocular lens implantation and at least 60 days prior to Day 1.
- •8.Any ophthalmic condition that may require surgery during the study period.
- •9.Any contraindication to IVT injection including current ocular or periocular infection in either eye.
- •10.History of uveitis or endophthalmitis in either eye.
- •11.Current uncontrolled intraocular pressure (determined by the Investigator) or history of ocular hypertension or glaucoma.
- •12.Presence of iris neovascularisation and/or vitreous or preretinal haemorrhage.
- •13.Prior vitrectomy, glaucoma filtration surgery, or any ocular procedure which could affect drug distribution or clearance.
- •14.Ocular trauma to the eye within the preceding 6 months.
- •15.Participation in another interventional clinical study, or use of any experimental treatment for AMD or any other investigational product within 6 weeks or 5 half-lives (whichever is longer) prior to the start of study treatment. Clinical trials solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary.
- •16.Systemic conditions which may contraindicate the use of mineralocorticoids, e.g. tuberculosis, uncontrolled hypertension, hypothyroidism, Cushing’s syndrome, hypokalaemia, myasthenia gravis, fungal infections, chronic heart failure, kidney disease with reduction in kidney function and fluid retention in the legs, or feet, or arms, or hands.
- •17.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.
- •18.Screening laboratory value (haematology, serum chemistry, or urinalysis) that in the opinion of the Investigator is clinically significant and not suitable for study participation.
- •19.Hypersensitivity to fluorescein
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