Phase I Study of Palomid 529 a Dual TORC1/2 Inhibitor of the PI3K/Akt/mTOR Pathway for Advanced Neovascular Age-Related Macular Degeneration

Inclusion criteria

• Best corrected visual acuity in the study eye between 20/100 and 20/800 (between 53 and 4 ETDRS letters read), and better or equal to 20/200 (minimum of 34 letters read) in the fellow eye.
• Subfoveal choroidal neovascularization (CNV) due to AMD
• Total area of the lesion (including blood, neovascularization and scar/atrophy) must be < 12 DA.
• Only 1 eye will be treated in the study. If both eyes are eligible, the investigator will select the eye with the most active CNV
• Clear ocular media and adequate pupillary dilatation to permit good stereo fundus photography for screening
• Intraocular pressure of 21 mm Hg or less
• Retinal thickness ≥ 250 μm by OCT, with presence of intraretinal or subretinal fluid

Exclusion criteria

• Any retinovascular disease or retinal degeneration other than AMD
• Serous pigment epithelial detachment without the presence of neovascularization
• Previous posterior vitrectomy or retinal surgery
• Any periocular infection in the past 4 weeks
• Concomitant therapy with anti-VEGF therapies, e.g. Avastin, Lucentis or Macugen, or previous use of these agents within 60 days of screening
• Concomitant therapy with intravenous or intravitreous corticosteroids or use within 90 days of screening
• Significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity, or fundus photography
• Cataract surgery in the study eye within 3 months of screening
• Intraocular surgery in the study eye within 3 months of screening
• Presence of ocular infection in the study eye
• Presence of severe myopia (-8 diopters or greater) in the study eye