Recruiting
Phase 1

CG-P5 Peptide

Sponsor:

Caregen Co. Ltd.

Code:

NCT06132035

Conditions

Age-related Wet Macular Degeneration

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

CG-P5 peptide

Placebo

Aflibercept Injection [Eylea]

Study Details

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

Study ID

NCT06132035

Start date

Dec 22, 2023

Status verified date

Feb, 2025

Completion date

Aug, 2025

Anticipated

Primary completion date

May, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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
  • 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

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
  • 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
  • Concurrent use of systemic anti-VEGF agents
  • Any ophthalmic device implantation within the previous 12 months
  • Patients with a clinically significant abnormal screening hematology, blood chemistry, or urinalysis, unsuitable for study participation in the investigator's opinion
  • Aspartate Transaminase (AST), Alanine Transaminase (ALT), alkaline phosphatase, Gamma-glutamyl Transferase (GGT), total bilirubin, direct bilirubin, indirect bilirubin, and LDH ≥ 2.0-fold the upper limit of normal at screening
  • Patient with impaired renal function defined as calculated creatinine clearance (CLCr) <30mL/min

  • Males: CLCr = \[140 - a(years)\] x weight(kg)/ 72 x serum creatinine (mg/dL)
  • Females: CLCr = \[140 - a(years)\] x weight(kg) (x 0.85)/ 72 x serum creatinine (mg/dL)
  • Significant alcohol or drug abuse within past 2 years per investigator judgement
  • Previous participation in other trials for treatment of wAMD with systemic administration if washout period from last administration is shorter than 3 months
  • Significant disease or other medical conditions (as determined by medical history, examination, and clinical investigations at screening) that may, in the opinion of the investigator result in the any of the following:

  • Put the patient at risk because of participation in the study,
  • Influence the results of the study,
  • Cause concern regarding the patient's ability to participate in the study
  • Known hypersensitivity to fluorescein or any of the ingredients used in the study drug formulation, or any of the medications used during the study
  • Active infectious conjunctivitis in either eye
  • Women of childbearing potential who are lactating or who are pregnant as determined by serum pregnancy test at screening
  • Women of childbearing potential must have agreed to use adequate birth control methods for the duration of the study
  • Post-menopausal women should have documented last MC 2 years before study participation

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CG-P5 peptide eye drops

placebo comparator: Placebo Eye drops

active comparator: Intravitreal injection of Eylea®

Interventions

CG-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

Placebo

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

Aflibercept Injection [Eylea]

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

Primary outcome measure

  • 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 [ Time Frame: Screening, Day 0, Day 28, Day 56 & Day 84 ]
  • Change in intraocular inflammation with study drug compared to placebo [ 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 [ Time Frame: Day 0, Day 28, Day 56 & Day 84 ]

Central Contacts and Locations

Central contacts

Ishita Trivedi

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

Eldho Jose

eldho.jose@cbcc.global

Locations

CBCC Global Research Site:005

Recruiting

Manchester, Connecticut, United States, 06042

CBCC Global Research Site:006

Recruiting

Deerfield Beach, Florida, United States, 33064

CBCC Global Research Site:001

Recruiting

Augusta, Georgia, United States, 30909

CBCC Global Research Site:004

Recruiting

Carmel, Indiana, United States, 46290

CBCC Global Research Site:003

Recruiting

Fargo, North Dakota, United States, 58104

CBCC Global Research Site:002

Recruiting

Erie, Pennsylvania, United States, 16507

CBCC Global Research Site:007

Recruiting

Philadelphia, Pennsylvania, United States, 19141

More Information

Sponsor

Caregen Co. Ltd.

Last update posted

Feb 7, 2025

Last verified

Feb, 2025

Keywords

  • Age-Related Macular Degeneration
  • Macular Degeneration
  • wAMD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Caregen Co. Ltd. on 2025-02-07.