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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

Study to Evaluate the Safety of CG-P5 Peptide Eye Drops in Patients Diagnosed With Age-related Wet Macular Degeneration (NCT06132035) is a Phase 1 interventional studying Age-related Wet Macular Degeneration, sponsored by Caregen Co. Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Age-related Wet Macular Degeneration, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 45 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Male or female patients ≥50 years of age - Willing and able to provide written willing to sign a consent form - 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 Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

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

DRUG

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

DRUG

Aflibercept Injection [Eylea]

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

Locations (7)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06132035), the sponsor (Caregen Co. Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06132035 clinical trial studying?

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 The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06132035?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06132035?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06132035. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06132035. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.