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
Caregen Co. Ltd.
Summary
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
Eligibility
- Age range
- 50+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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-…
Interventions
- DrugCG-P5 peptide
Patient will instill daily 1 package of CG-P5 peptide eye drops in the study eye \[self-administered\] using the single use tear-off disposable packaging
- DrugPlacebo
Patient will instill daily 1 package of Placebo eye drops in the study eye \[self-administered\] using the single use tear-off disposable packaging
- DrugAflibercept Injection [Eylea]
Patient will receiver Eylea® (Aflibercept) intravitreal injection once in a month
Locations (7)
- CBCC Global Research Site:005Manchester, Connecticut
- CBCC Global Research Site:006Deerfield Beach, Florida
- CBCC Global Research Site:001Augusta, Georgia
- CBCC Global Research Site:004Carmel, Indiana
- CBCC Global Research Site:003Fargo, North Dakota
- CBCC Global Research Site:002Erie, Pennsylvania