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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 28, day 56 & day 84

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 28, day 56 & day 84

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 28, day 56 & day 84

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

+2 more

Secondary outcome measures

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

Change from Baseline in Central Subfield Thickness (CST) as measured by spectral domain optical coherence tomography (SD-OCT) over the study duration

Change from Baseline in Choroidal Neovascularization (CNV) area as measured by Fluorescein Angiography (FA) over the study duration

+17 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 / 4Eligibility 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.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there openings still available for participants in this medical experiment?

"Unfortunately, the study listed on clinicaltrials.gov is no longer enrolling participants as it was last updated on November 13th 2023. Despite this, there are 172 other investigations that are presently recruiting patients at the moment."

Answered by AI

Has the federal agency approved CG-P5 peptide eye drops for use?

"With limited research regarding its efficacy and safety, the CG-P5 peptide eye drops were given a score of 1."

Answered by AI

How many physical locations is this trial taking place in?

"For this clinical trial, CBCC Global Research Site:003 in Fargo, North dakota; CBCC Global Research Site:002 in Erie, Pennsylvania; and CBCC Global Research Site:004 in Carmel, Indiana are just a few of the sites accepting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Study to Evaluate the Safety of CG-P5 Peptide Eye Drops in Patients Diagnosed With Age-related Wet Macular Degeneration". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06132035.