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

NCT06132035 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CG_P5_2023W1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 7

Brief 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

Conditions

Age-related Wet Macular Degeneration

Keywords

Age-Related Macular Degeneration; Macular Degeneration; wAMD

Outcome Measures

Primary Outcomes (5)

• The percentage of occurrence of Adverse Events (AE)

  Screening, Day 0, Day 28, Day 56 & Day 84

• The number of Adverse Events (AE) that occurs

  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

  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

  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

  Day 0, Day 28, Day 56 & Day 84

Secondary Outcomes (20)

• 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

  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

  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

  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

  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

  Screening, Day 0, Day 28, Day 56 & Day 84

Study Arms (3)

CG-P5 peptide eye drops

EXPERIMENTAL

Drug: CG-P5 peptide

Placebo Eye drops

PLACEBO COMPARATOR

Drug: Placebo

Intravitreal injection of Eylea®

ACTIVE COMPARATOR

Drug: Aflibercept Injection [Eylea]

Interventions

CG-P5 peptide DRUG

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

CG-P5 peptide eye drops

Placebo DRUG

Patient will instill daily 1 package of Placebo eye drops in the study eye \[self-administered\] using the single use tear-off disposable packaging

Placebo Eye drops

Aflibercept Injection [Eylea] DRUG

Patient will receiver Eylea® (Aflibercept) intravitreal injection once in a month

Intravitreal injection of Eylea®

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Current or planned use of medications known to be toxic to the retina, lens, or optic nerve (e.g., deferoxamine, chloroquine/hydro chloroquine, chlorpromazine, phenothiazines, tamoxifen, nicotinic acid, and ethambutol)
• Medical history or condition: Uncontrolled diabetes mellitus, with glycosylated hemoglobin (HbA1c) \> 10%, myocardial infarction or stroke within 12 months of screening, active bleeding disorder, major surgery within 1 month of screening or when planned within the study period, hepatic impairment, uncontrolled hypertension, other unstable or progressive cardiovascular, pulmonary, Parkinson, liver, or renal disease or cancer or dementia
• Previous treatment with intravenous bevacizumab or intravitreal ranibizumab, bevacizumab, aflibercept, pegaptanib in either of the eyes within four months prior to enrolment
• Previous treatment with verteporfin photodynamic therapy (PDT), thermal laser, transpupillary thermotherapy, intravitreal or protein kinase C inhibitors or other AMD therapy in the study eye within 3 months prior to randomization
• Previous treatment with intravitreal ocular or periocular steroids (e.g., triamcinolone, anecortave acetate) or peribulbar steroid in the study eye within past 3 months

Sponsors & Collaborators

• Caregen Co. Ltd.: lead
• CBCC Global Research: collaborator

Study Sites (7)

CBCC Global Research Site:005

Manchester, Connecticut, 06042, United States

RECRUITING

CBCC Global Research Site:006

Deerfield Beach, Florida, 33064, United States

RECRUITING

CBCC Global Research Site:001

Augusta, Georgia, 30909, United States

RECRUITING

CBCC Global Research Site:004

Carmel, Indiana, 46290, United States

RECRUITING

CBCC Global Research Site:003

Fargo, North Dakota, 58104, United States

RECRUITING

CBCC Global Research Site:002

Erie, Pennsylvania, 16507, United States

RECRUITING

CBCC Global Research Site:007

Philadelphia, Pennsylvania, 19141, United States

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Dr. Yong Ji Chung

  Caregen Co. Ltd.

  STUDY DIRECTOR

Central Study Contacts

Ishita Trivedi

CONTACT

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

Eldho Jose

CONTACT

eldho.jose@cbcc.global

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: November 15, 2023
• Study Start: December 22, 2023
• Primary Completion: May 1, 2025
• Study Completion: August 1, 2025
• Last Updated: February 7, 2025

Record last verified: 2025-02

Locations

US (7)