Safety and Tolerability Study for Age-Related Macular Degeneration

Exclusion Criteria

• •Any retinal vascular disease or retinal degeneration other than AMD in the study eye
• •Serous pigment epithelial detachment without the presence of choroidal neovascularization in the study eye
• •Pigment epithelial tears or rips in the study eye
• •Previous posterior vitrectomy or retinal surgery in the study eye
• •Any periocular infection in the past 4 weeks in the study eye
• •During the duration of the study, subjects cannot be on any concomitant therapy with anti-VEGF (Vascular Endothelial Growth Factor) agents, e.g., Lucentis® , Avastin®, or Macugen® in the study eye (unless identified as rescue therapy given according to protocol guidelines)
• •Concomitant therapy or use within 30 days of Baseline (Day 1) of systemic (e.g. intravenous, oral, intramuscular, rectal) corticosteroids in doses \> 10 mg/ day prednisone or prednisone equivalent, or use of intravitreous or periocular steroids within 90 days of Baseline (Day 1) in the study eye
• •Any current or prior use of extended-release steroid implants (e.g., Retisert®, Posurdex®, Medidur®) in the study eye
• •Significant media opacities, including cataract, in the study eye which might interfere with visual acuity, assessment of toxicity, or fundus photography.
• •Cataract surgery in the study eye within three months of screening
• •Trabeculectomy or outflow-device glaucoma surgery in the study eye
• •Intraocular surgery in the study eye within three months of screening
• •Periocular or ocular infection in the study eye
• •Severe myopia (spherical equivalent -8 diopters or greater) in the study eye
• •History of vascular pigment epithelial detachment or submacular hemorrhage in the fellow eye.
• •Use of any investigational agent or participation in any clinical trial of an investigational agent or investigational therapy that has the potential to affect the disease process (neovascular AMD) in the study eye within sixty (60) days of Baseline (Day 1), or participation in any other clinical trial of an investigational agent or investigational therapy within thirty (30) days of Baseline (Day 1). Participation in clinical trials of oral supplements of vitamins and minerals for the prevention of neovascular AMD (e.g. AREDS2) are allowed, as are studies that do not involve the administration of an investigational agent and/or investigational therapy
• •Undiagnosed acute illness first observed during screening or between screening and baseline, or severe concurrent medical conditions that, in the investigator's judgment, represent a safety concern.
• •Allergy to or prior significant adverse reaction to fluorescein
• •Any major surgical procedure within one month of trial entry
• •Blood pressure \>160/90 mmHg.