Phase I Clinical Study to Evaluate the Safety of CG-P5 Peptide Eye Drops (Self-administered and Topically Applied) in Patients Diagnosed With Age-related Wet Macular Degeneration
This will be a randomized, comparative, parallel, clinical study to assess initial safety and tolerability of CG-P5 peptide eye drops compared to placebo in patients diagnosed with age-related wet macular degeneration
• Male or female patients ≥50 years of age
• Willing and able to provide written informed consent
• Diagnosis of age-related wet macular degeneration (wAMD) in the study eye as determined by the investigator on fundus examination
• Primary or recurrent active choroidal neovascularization (CNV) lesions involving the foveal center secondary to age-related wet macular degeneration in any one of the eyes. (If both eyes are affected and eligible, the eye with the worse BCVA, as assessed at screening, will be selected as the study eye
• Best corrected visual acuity (BCVA) of 75-25 eye Early Treatment of Diabetic Retinopathy Study (ETDRS) letters (approximate Snellen equivalent between 20/ 32 to 20/320) inclusive before pupil dilation assessed at the initial testing distance of 4 meters
• Central Subfield Thickness (CST thickness) ≥ 250 microns on SD-OCT (exclusive of subretinal pigment epithelial fluid, inclusive of SRF)
• Presence of SRF and/or IRF on SD-OCT
• Total lesion size not greater than 12 disc areas (30.48 mm2) (1 disc area = 2.54 mm2) on FA
• If present, subretinal hemorrhage must comprise \< 50% of the total lesion area on FA, SD-OCT, or FAF
• No subfoveal fibrosis or atrophy on FA, SD-OCT, or FAF
• Active CNV membranes with subfoveal leakage or juxtafoveal leakage too close for laser photocoagulation
• Females who are of non-childbearing potential (surgically sterile or menopausal) OR if of childbearing potential using effective birth control and non-pregnant \& non-lactating
• Ability to follow protocol requirements