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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
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
Patient will instill daily 1 package of Placebo eye drops in the study eye \[self-administered\] using the single use tear-off disposable packaging
Patient will receiver Eylea® (Aflibercept) intravitreal injection once in a month
CBCC Global Research Site:005
Manchester, Connecticut, United States
RECRUITINGCBCC Global Research Site:006
Deerfield Beach, Florida, United States
RECRUITINGCBCC Global Research Site:001
Augusta, Georgia, United States
The percentage of occurrence of Adverse Events (AE)
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
The number of Adverse Events (AE) that occurs
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Change in IOP with study drug compared to placebo
Mean change in intraocular pressure (IOP) with study drug compared to placebo from baseline to end of study
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Change in intraocular inflammation with study drug compared to placebo
Mean change in intraocular inflammation with study drug compared to placebo from baseline to end of study
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Incidence and severity of ocular and non-ocular adverse events of CG-P5 peptide eye drops and Placebo
Mean change in incidence and severity of ocular and non-ocular adverse events of CG-P5 peptide eye drops and Placebo with study drug compared to placebo from baseline to end of study
Time frame: Day 0, Day 28, Day 56 & Day 84
Change in best corrected visual acuity (BCVA) of study drug compared to Eylea® and placebo as measured by ≥15 Early ETDRS letter score at the end of 84 days
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Change in CNV area on fluorescence angiography with study drug compared to Eylea® and placebo on day 28, day 56 and day 84
Time frame: Day 28, Day 56 & Day 84
Mean decrease in central retinal thickness on SD-OCT with study drug compared to Eylea® and placebo from baseline to end of study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CBCC Global Research Site:004
Carmel, Indiana, United States
RECRUITINGCBCC Global Research Site:003
Fargo, North Dakota, United States
RECRUITINGCBCC Global Research Site:002
Erie, Pennsylvania, United States
RECRUITINGCBCC Global Research Site:007
Philadelphia, Pennsylvania, United States
RECRUITINGTime frame: Screening, Day 0, Day 28, Day 56 & Day 84
Mean decrease in total macular volume on optical coherence tomography with study drug compared to Eylea® and placebo from baseline to end of study
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Proportion of patients with change in BCVA with study drug compared to Eylea® and placebo from baseline to end of study
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Number of patients with change in BCVA with study drug compared to Eylea® and placebo from baseline to end of study
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Proportion of patients with change in intraocular pressure (IOP) with study drug compared to Eylea® and placebo from baseline to end of study
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Number of patients with change in intraocular pressure (IOP) with study drug compared to Eylea® and placebo from baseline to end of study
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Proportion of patients with change in intraocular inflammation with study drug compared to Eylea® and placebo from baseline to end of study
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Number of patients with change in intraocular inflammation with study drug compared to Eylea® and placebo from baseline to end of study
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Proportion of patients with change in central retinal thickness with study drug compared to Eylea® and placebo from baseline to end of study
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Number of patients with change in central retinal thickness with study drug compared to Eylea® and placebo from baseline to end of study
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Proportion of patients with change in total macular volume with study drug compared to Eylea® and placebo from baseline to end of study
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Number of patients with change in total macular volume with study drug compared to Eylea® and placebo from baseline to end of study
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Change from Baseline in Choroidal Neovascularization (CNV) area as measured by Fluorescein Angiography (FA) over the study duration
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Change from Baseline in Central Subfield Thickness (CST) as measured by spectral domain optical coherence tomography (SD-OCT) over the study duration
Time frame: Screening, Day 0, Day 28, Day 56 & Day 84
Area under the concentration-time curve from dosing (time 0) to time t [AUC(0-t)]
Pharmacokinetic profile of CG-P5 peptide eye drops measured by AUC(0-t)
Time frame: Day 0 & Day 84
Maximum Plasma Concentration [Cmax]
Pharmacokinetic profile of CG-P5 peptide eye drops measured by Cmax
Time frame: Day 0 & Day 84
Time of peak plasma concentration [Tmax]
Pharmacokinetic profile of CG-P5 peptide eye drops measured by Tmax
Time frame: Day 0 & Day 84
Half-life [t½]
Pharmacokinetic profile of CG-P5 peptide eye drops measured by t½
Time frame: Day 0 & Day 84