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Study to Evaluate the Safety of CG-P5 Peptide Eye Drops in Patients Diagnosed With Age-related Wet Macular Degeneration | Clinical Trials | Clareo Health

RECRUITINGPHASE1

Study to Evaluate the Safety of CG-P5 Peptide Eye Drops in Patients Diagnosed With Age-related Wet Macular Degeneration

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

NCT06132035•Caregen Co. Ltd.

View on ClinicalTrials.gov

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

50 - No limit years

Sex

ALL

Healthy Volunteers

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 75-25 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
+3 more criteria

Exclusion Criteria

•Patients having additional eye disease in the posterior segment of study eye other than wAMD
•Any other pathology involving the CNV lesion like retro foveolar atrophy or permanent structural damage to fovea or fibrosis/ hemorrhage involving fovea \> 50 % of lesion area of study eye that can affect the efficacy of drug
•Vitreous hemorrhage or history of rhegmatogenous retinal detachment, retinal pigment epithelial tear involving the macula or macular hole (stage 3 or 4) in the study eye
•Aphakia or absence of the posterior capsule in the study eye
•History or expectation of the following surgery in the study eye:
•* Vitrectomy within last 1 month
•* Cataract surgery or Lasik within the last 3 months
•* Planned cataract removal surgery during the study
•A history or medical diagnosis of uncontrolled glaucoma (defined as IOP \>25mmHg even with anti-glaucoma medication), advanced glaucoma resulting in a cup/disc ratio \>0.8 in the study eye, or glaucoma filtration surgery in the study eye
•Serious complications following surgery in the study eye within 1 year
+23 more criteria

Locations (7)

CBCC Global Research Site:005

Manchester, Connecticut, United States

CBCC Global Research Site:006

Deerfield Beach, Florida, United States

CBCC Global Research Site:001

Augusta, Georgia, United States

CBCC Global Research Site:004

Carmel, Indiana, United States

CBCC Global Research Site:003

Fargo, North Dakota, United States

CBCC Global Research Site:002

Erie, Pennsylvania, United States

CBCC Global Research Site:007

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

December 22, 2023

Primary Completion Date

May 1, 2025

Completion Date

August 1, 2025

Last Updated

February 7, 2025

Enrollment

ESTIMATED participants

Conditions

Age-related Wet Macular Degeneration

Interventions

CG-P5 peptide

DRUG

Placebo

DRUG

Aflibercept Injection [Eylea]

DRUG

Contacts

Ishita Trivedi

CONTACT

+1- 609-594-6709 ishita.trivedi@cbcc.global

Eldho Jose

CONTACT

eldho.jose@cbcc.global