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

Exclusion Criteria20

• GA due to causes other than AMD such as Stargardt disease, cone rod dystrophy, or toxic maculopathies like plaquenil maculopathy.
• Spherical equivalent refractive error of -6.00 diopters of myopia or worse, or an axial length greater than 26 mm.
• Any history, or current evidence of exudative (“wet”) AMD; including any evidence of RPE rips or evidence of neovascularisation anywhere in the retina.
• Retinal disease other than AMD; however, benign conditions of the vitreous or peripheral retina are not exclusionary (ie, pavingstone degeneration).
• 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).
• Intraocular surgery (including lens replacement surgery) within 3 months prior to randomisation.
• 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.
• Any ophthalmic condition that may require surgery during the study period.
• Any contraindication to IVT injection including current ocular or periocular infection in either eye.
• History of uveitis or endophthalmitis in either eye.
• Current uncontrolled intraocular pressure (determined by the Investigator) or history of ocular hypertension or glaucoma.
• Presence of iris neovascularisation and/or vitreous or preretinal haemorrhage.
• Prior vitrectomy, glaucoma filtration surgery, or any ocular procedure which could affect drug distribution or clearance.
• Ocular trauma to the eye within the preceding 6 months.
• 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.
• 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.
• 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.
• Screening laboratory value (haematology, serum chemistry, or urinalysis) that in the opinion of the Investigator is clinically significant and not suitable for study participation.
• Hypersensitivity to fluorescein