CG-P5 Peptide for Age-Related Macular Degeneration

Recruiting at 6 trial locations

Overseen By Eldho Jose

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Caregen Co. Ltd.

Must not be taking: Retina-toxic drugs

Disqualifiers: Uncontrolled diabetes, Glaucoma, others

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new eye drop treatment called CG-P5 peptide for age-related wet macular degeneration, a condition that causes vision loss due to abnormal blood vessels growing under the retina. The study will compare these eye drops to a placebo (inactive substance) and an existing treatment, Eylea® injections, to assess safety and tolerability. Individuals diagnosed with age-related wet macular degeneration who experience symptoms like blurry or dark areas in their vision may be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot use medications known to be toxic to the eye or systemic anti-VEGF agents. If you have been treated with certain eye therapies recently, you may need to wait before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the CG-P5 peptide eye drops are being tested for safety in people with age-related wet macular degeneration. This is a Phase 1 trial, focusing on how well participants tolerate the treatment and identifying any side effects. These early trials typically involve only a few participants to allow for close monitoring of effects.

Specific safety data for CG-P5 peptide is not yet available, but Phase 1 trials are the first step in testing new treatments. They determine if the treatment is safe for humans. Progressing beyond this stage usually indicates that the treatment was well-tolerated and did not cause serious side effects in initial testing. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike traditional treatments for age-related macular degeneration, which often involve intravitreal injections like Eylea®, CG-P5 peptide offers a new approach with eye drops. This delivery method is less invasive, potentially improving patient comfort and compliance. Additionally, the CG-P5 peptide might have a novel mechanism of action that provides benefits not seen with existing treatments. Researchers are excited about its potential to offer effective management of the condition in a more convenient form.

What evidence suggests that this trial's treatments could be effective for age-related macular degeneration?

Research has shown that CG-P5 peptide eye drops, a treatment under study in this trial, might help treat age-related wet macular degeneration. Early results suggest they could benefit individuals new to treatment or those who have just started using anti-VEGF therapy, a common method for managing this eye condition. Although detailed information from human studies remains limited, the peptide aims to slow the growth of harmful areas in the eye that cause vision loss. Overall, the treatment is still under investigation, but initial findings are promising for those with this condition. ^{1 2 3 4 6}

Who Is on the Research Team?

Dr. Yong Ji Chung

Principal Investigator

Caregen Co. Ltd.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

The total size of the lesions in your eyes should not be larger than 12 disc areas, which is about 30.48 square millimeters.

You are able to read and sign a paper agreeing to take part in the study.

You can follow the rules of the study.

Exclusion Criteria

Any ophthalmic device implantation within the previous 12 months

I haven't had certain eye treatments in the last 4 months.

Patients with a clinically significant abnormal screening hematology, blood chemistry, or urinalysis, unsuitable for study participation in the investigator's opinion

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive CG-P5 peptide eye drops or placebo, with assessments at specified intervals

12 weeks

Visits on Day 0, Day 28, Day 56, and Day 84

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CG-P5 peptide

Trial Overview 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.

How Is the Trial Designed?

Group I: CG-P5 peptide eye drops Experimental Treatment 1 Intervention

Group II: Intravitreal injection of Eylea® Active Control 1 Intervention

Group III: Placebo Eye drops Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Caregen Co. Ltd.

Lead Sponsor

Trials

2

Recruited

60+

CBCC Global Research

Collaborator

Trials

8

Recruited

1,300+

Published Research Related to This Trial

Avacincaptad pegol (ACP) significantly reduced the growth of geographic atrophy (GA) in patients with age-related macular degeneration (AMD) by 28.1% with the 2 mg dose and 30.0% with the 4 mg dose over an 18-month treatment period compared to sham treatment.

The treatment was generally well tolerated, although there was an increased incidence of macular neovascularization in the ACP groups compared to sham, indicating a need for monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Avacincaptad pegol for geographic atrophy secondary to age-related macular degeneration: 18-month findings from the GATHER1 trial. Patel, SS., Lally, DR., Hsu, J., et al.[2023]

The chimeric HDL mimetic peptide HM-10/10 has shown protective effects against oxidative stress-induced cell death in retinal pigment epithelium (RPE) cells, suggesting its potential as a treatment for age-related macular degeneration (AMD).

In animal models, HM-10/10 not only prevented RPE atrophy but also improved retinal function and reduced photoreceptor cell death, indicating its efficacy in combating retinal degeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel HDL-Mimetic Peptide HM-10/10 Protects RPE and Photoreceptors in Murine Models of Retinal Degeneration. Su, F., Spee, C., Araujo, E., et al.[2020]

Factor P (properdin) was found in 50% of choroidal neovascular membranes from patients with age-related macular degeneration (AMD), indicating its potential role in the disease's pathology.

Patients with Factor P-positive membranes experienced longer visual loss and larger areas of atrophic retinal pigment epithelium post-surgery, suggesting that Factor P may be associated with worse clinical outcomes in AMD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complement Factor P in choroidal neovascular membranes of patients with age-related macular degeneration. Wolf-Schnurrbusch, UE., Stuck, AK., Hess, R., et al.[2009]

A newly designed peptide (Peptide 2) shows significantly improved solubility and maintains strong complement-inhibiting activity, making it a promising candidate for treating age-related macular degeneration (AMD).

Peptide 2 is more effective in inhibiting complement activation in a cell-based model of dry AMD compared to its predecessor (Peptide 1), suggesting enhanced therapeutic potential for clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peptide redesign for inhibition of the complement system: Targeting age-related macular degeneration. Mohan, RR., Cabrera, AP., Harrison, RE., et al.[2018]

A systematic review of 95 studies involving 3105 eyes with neovascular age-related macular degeneration (nAMD) revealed that several inflammatory cytokines, including MCP-1, MIG, TGF-β, and VEGF, were significantly elevated in patients with nAMD compared to healthy controls, indicating their potential role as biomarkers.

This analysis highlights the importance of these cytokines in the pathogenesis of nAMD and suggests that they could serve as targets for future therapeutic interventions, moving beyond the traditionally focused VEGF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in aqueous and vitreous inflammatory cytokine levels in neovascular age-related macular degeneration: a systematic review and meta-analysis. Minaker, SA., Mason, RH., Lahaie Luna, G., et al.[2021]

CEP modifications of lysyl residues in proteins are linked to age-related macular degeneration (AMD), contributing to both wet and dry forms of the disease, and their blood levels serve as biomarkers for prognosis.

An efficient synthesis method for CEP derivatives was developed, allowing for the introduction of multiple modifications to proteins without denaturing them, which facilitates further mechanistic studies on how these modifications promote AMD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synthesis and structural characterization of carboxyethylpyrrole-modified proteins: mediators of age-related macular degeneration. Lu, L., Gu, X., Hong, L., et al.[2021]

Only about 0.1% of the Polish population requires treatment for neovascular age-related macular degeneration (nAMD) when considering patients without severe irreversible eye damage, indicating a relatively low prevalence of this condition needing intervention.

The COVID-19 pandemic significantly impacted the enrollment in the national AMD therapeutic program, with a notable decrease in monthly enrollments, highlighting potential barriers to treatment access during health crises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Need for Treatment of Neovascular Age-Related Macular Degeneration: A Study Based on the Polish National Registry. Teper, SJ., Nowińska, A., Figurska, M., et al.[2022]

Activation of the complement cascade is linked to age-related macular degeneration (AMD), with genetic studies showing strong associations between complement gene SNPs and dry-type AMD in the American population.

In a primate model of early-onset macular degeneration, the C3 inhibitor Compstatin led to the disappearance of drusen after 6 months of treatment, suggesting a potential therapeutic approach to delay or reverse AMD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suppression of drusen formation by compstatin, a peptide inhibitor of complement C3 activation, on cynomolgus monkey with early-onset macular degeneration. Chi, ZL., Yoshida, T., Lambris, JD., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06132035

Study to Evaluate the Safety of CG-P5 Peptide Eye Drops ... Study to Evaluate the Safety of CG-P5 Peptide Eye Drops in Patients Diagnosed With Age-related Wet Macular Degeneration. ClinicalTrials.gov ID NCT06132035.

2. withpower.com withpower.com/trial/cg-p5-peptide-for-age-related-macular-degeneration-cc199

CG-P5 Peptide for Age-Related Macular Degeneration Avacincaptad pegol (ACP) significantly reduced the growth of geographic atrophy (GA) in patients with age-related macular degeneration (AMD) by 28.1% with the 2 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06132035?term=AREA%5BBasicSearch%5D(amd%20007)&rank=3

Study to Evaluate the Safety of CG-P5 Peptide Eye Drops ... Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age ...

4. retinatoday.com retinatoday.com/articles/2024-nov-dec/wet-amd-therapies-in-the-pipeline

Wet AMD Therapies in the Pipeline Data published in Eye suggest that the therapeutic is effective in treatment-naïve wet AMD patients or those with a short history of anti-VEGF treatment.

5. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/cg-p5-peptide-caregen-wet-neovascular-exudative-macular-degeneration-likelihood-of-approval/

CG-P5 peptide by Caregen for Wet (Neovascular ... According to GlobalData, Phase I drugs for Wet (Neovascular / Exudative) Macular Degeneration have an 89% phase transition success rate (PTSR) ...

6. go.drugbank.com go.drugbank.com/drugs/DB08885/clinical_trials?conditions=DBCOND0158368&phase=1&purpose=treatment&status=recruiting

Aflibercept Recruiting Phase 1 Trials for Neovascular (Wet) ... Study to Evaluate the Safety of CG-P5 Peptide Eye Drops in Patients Diagnosed With Age-related Wet Macular Degeneration. Aflibercept (DB08885); CG-P5 ...