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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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

Locations
United States
Connecticut
CBCC Global Research Site:005
RECRUITING
Manchester
Florida
CBCC Global Research Site:006
RECRUITING
Deerfield Beach
Georgia
CBCC Global Research Site:001
RECRUITING
Augusta
Indiana
CBCC Global Research Site:004
RECRUITING
Carmel
North Dakota
CBCC Global Research Site:003
RECRUITING
Fargo
Pennsylvania
CBCC Global Research Site:002
RECRUITING
Erie
CBCC Global Research Site:007
RECRUITING
Philadelphia
Contact Information
Primary
Ishita Trivedi
ishita.trivedi@cbcc.global
+1- 609-594-6709
Backup
Eldho Jose
eldho.jose@cbcc.global
Time Frame
Start Date: 2023-12-22
Estimated Completion Date: 2025-08
Participants
Target number of participants: 45
Treatments
Experimental: CG-P5 peptide eye drops
Placebo_comparator: Placebo Eye drops
Active_comparator: Intravitreal injection of Eylea®
Sponsors
Leads: Caregen Co. Ltd.
Collaborators: CBCC Global Research

This content was sourced from clinicaltrials.gov