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

Last updated: February 5, 2025
Sponsor: Caregen Co. Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Macular Degeneration

Geographic Atrophy

Treatment

Placebo

Aflibercept Injection [Eylea]

CG-P5 peptide

Clinical Study ID

NCT06132035
CG_P5_2023W1
  • Ages > 50
  • All Genders

Study 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 Criteria

Inclusion

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 asdetermined by the investigator on fundus examination

  • Primary or recurrent active choroidal neovascularization (CNV) lesions involving thefoveal center secondary to age-related wet macular degeneration in any one of theeyes. (If both eyes are affected and eligible, the eye with the worse BCVA, asassessed at screening, will be selected as the study eye

  • Best corrected visual acuity (BCVA) of 75-25 eye Early Treatment of DiabeticRetinopathy 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 ofsubretinal 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 = 2.54mm2) on FA

  • If present, subretinal hemorrhage must comprise < 50% of the total lesion area onFA, 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 forlaser photocoagulation

  • Females who are of non-childbearing potential (surgically sterile or menopausal) ORif of childbearing potential using effective birth control and non-pregnant &non-lactating

  • Ability to follow protocol requirements

Exclusion

Exclusion Criteria:

  • Patients having additional eye disease in the posterior segment of study eye otherthan wAMD

  • Any other pathology involving the CNV lesion like retro foveolar atrophy orpermanent 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 pigmentepithelial 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 evenwith anti-glaucoma medication), advanced glaucoma resulting in a cup/disc ratio >0.8in 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, oroptic nerve (e.g., deferoxamine, chloroquine/hydro chloroquine, chlorpromazine,phenothiazines, tamoxifen, nicotinic acid, and ethambutol)

  • Medical history or condition: Uncontrolled diabetes mellitus, with glycosylatedhemoglobin (HbA1c) > 10%, myocardial infarction or stroke within 12 months ofscreening, active bleeding disorder, major surgery within 1 month of screening orwhen planned within the study period, hepatic impairment, uncontrolled hypertension,other unstable or progressive cardiovascular, pulmonary, Parkinson, liver, or renaldisease or cancer or dementia

  • Previous treatment with intravenous bevacizumab or intravitreal ranibizumab,bevacizumab, aflibercept, pegaptanib in either of the eyes within four months priorto enrolment

  • Previous treatment with verteporfin photodynamic therapy (PDT), thermal laser,transpupillary thermotherapy, intravitreal or protein kinase C inhibitors or otherAMD 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 withinpast 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, bloodchemistry, or urinalysis, unsuitable for study participation in the investigator'sopinion

  • Aspartate Transaminase (AST), Alanine Transaminase (ALT), alkaline phosphatase,Gamma-glutamyl Transferase (GGT), total bilirubin, direct bilirubin, indirectbilirubin, 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 systemicadministration 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 ofthe 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 studydrug 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 determinedby serum pregnancy test at screening

  • Women of childbearing potential must have agreed to use adequate birth controlmethods for the duration of the study

  • Post-menopausal women should have documented last MC 2 years before studyparticipation

Study Design

Total Participants: 45
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 1
Study Start date:
December 22, 2023
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • CBCC Global Research Site:005

    Manchester, Connecticut 06042
    United States

    Active - Recruiting

  • CBCC Global Research Site:006

    Deerfield Beach, Florida 33064
    United States

    Active - Recruiting

  • CBCC Global Research Site:001

    Augusta, Georgia 30909
    United States

    Active - Recruiting

  • CBCC Global Research Site:004

    Carmel, Indiana 46290
    United States

    Active - Recruiting

  • CBCC Global Research Site:003

    Fargo, North Dakota 58104
    United States

    Active - Recruiting

  • CBCC Global Research Site:002

    Erie, Pennsylvania 16507
    United States

    Active - Recruiting

  • CBCC Global Research Site:007

    Philadelphia, Pennsylvania 19141
    United States

    Active - Recruiting

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