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Peptide Therapy

CG-P5 Peptide for Age-Related Macular Degeneration

Phase 1

Waitlist Available

Research Sponsored by Caregen Co. Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female patients ≥50 years of age

Active CNV membranes with subfoveal leakage or juxtafoveal leakage too close for laser photocoagulation

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0, day 28, day 56 & day 84

Awards & highlights

Summary

This trial will compare a new eye drop for age-related macular degeneration to a placebo to assess safety and effectiveness.

Who is the study for?

This trial is for men and women over 50 with wet age-related macular degeneration (wAMD) in one eye. They must have certain levels of vision clarity, a specific thickness in the retina, and active blood vessel growth under the fovea. Women must be non-childbearing or using birth control. Excluded are those with other major eye diseases, recent surgeries, uncontrolled health conditions like diabetes or hypertension, or who've had certain wAMD treatments recently.

What is being tested?

The study tests CG-P5 peptide eye drops against a placebo to see if they're safe for people with wAMD. It's randomized: participants don't choose their treatment group. Some will get the real drug; others won't (placebo). A known treatment called Aflibercept [Eylea] is also part of the study for comparison purposes.

What are the potential side effects?

While side effects aren't detailed here, typical ones from eye drops may include irritation at the application site, redness, discomfort or itching in the eyes. Since this trial includes an injection (Aflibercept), there could also be risks associated with injections such as infection or inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 50 years old or older.

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I have leaking in the center or near the center of my retina that can't be treated with laser.

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I have been diagnosed with wet macular degeneration in one eye.

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I have wet age-related macular degeneration affecting my eye's central vision.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an eye condition besides wet AMD in the study eye.

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My eye condition involves more than half of the lesion area with damage or bleeding that could affect treatment.

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My eye has had severe bleeding, a torn retina, or a major hole in the macula.

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I do not have a natural lens or the back part of the lens in my study eye.

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I have had eye surgery recently or plan to have cataract removal soon.

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I do not have uncontrolled diabetes, recent heart attack or stroke, active bleeding disorders, major recent surgery, liver problems, uncontrolled high blood pressure, or unstable heart, lung, kidney diseases, Parkinson's disease, another cancer or dementia.

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I am currently using medication that targets blood vessel growth.

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I currently have pink eye in one or both eyes.

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I am a post-menopausal woman with my last menstrual cycle over 2 years ago.

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I haven't had specific eye treatments for AMD in the last 3 months.

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My kidney function is low, with a creatinine clearance under 30 mL/min.

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I am pregnant or breastfeeding.

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I have severe or uncontrolled glaucoma or had glaucoma surgery in the eye being studied.

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I am not using any medication known to harm my eyes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0, day 28, day 56 & day 84

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 0, day 28, day 56 & day 84

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0, day 28, day 56 & day 84 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in IOP with study drug compared to placebo

Change in intraocular inflammation with study drug compared to placebo

Incidence and severity of ocular and non-ocular adverse events of CG-P5 peptide eye drops and Placebo

Secondary study objectives

Area under the concentration-time curve from dosing (time 0) to time t [AUC(0-t)]

Half-life [t½]

Maximum Plasma Concentration [Cmax]

+1 more

Side effects data

From 2020 Phase 4 trial • 26 Patients • NCT03022292

Retinal detachment

Myelodysplastic syndrome

Pneumonia

100%

80%

60%

40%

20%

Study treatment Arm

IAI Treatment

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: CG-P5 peptide eye dropsExperimental Treatment1 Intervention

Group II: Intravitreal injection of Eylea®Active Control1 Intervention

Group III: Placebo Eye dropsPlacebo Group1 Intervention

0 / 18Eligibility criteria met

Find a Location

Who is running the clinical trial?

CBCC Global ResearchNETWORK

7 Previous Clinical Trials

1,238 Total Patients Enrolled

Caregen Co. Ltd.Lead Sponsor

1 Previous Clinical Trials

16 Total Patients Enrolled

Dr. Yong Ji ChungStudy DirectorCaregen Co. Ltd.

~0 spots leftby Oct 2024

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