A study to determine the safety and tolerability of an intravitreal steroid in the treatment of dry Age Related Macular Degeneration.

Exclusion Criteria18

• GA due to causes other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like plaquenil maculopathy.
• Spherical equivalent of the refractive error demonstrating > 6 dioptres of myopia or an axial length of >26 mm.
• 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.
• Retinal disease likely to confound visual performance or be affected by intraocular steroid.
• 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).
• Any ophthalmologic condition that prevents adequate imaging of the retina judges by the PI.
• Intraocular surgery (including lens replacement surgery) within 3 months prior to dosing.
• 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.
• Any ophthalmologic condition that may require surgery during the study period.
• Uncontrolled glaucoma defined as intraocular pressure >25 mmHg on maximal therapy.
• Any contraindication of IVT injection including current ocular or periocular infection.
• History of uveitis or endophthalmitis.
• History of choroidal neovascularization (CNV) in either eye.
• History of IVT injection at any time.
• 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.
• 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.
• 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.
• History or current evidence of hypersensitivity to any components of the study medication or fluorescein.