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

Trial Summary

What is the purpose of 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

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.

What data supports the effectiveness of the drug CG-P5 peptide for age-related macular degeneration?

Research on similar treatments, like avacincaptad pegol, a C5 inhibitor, shows effectiveness in treating geographic atrophy related to age-related macular degeneration. Additionally, studies on peptides that inhibit the complement system, like Compstatin, have shown promise in reducing drusen formation, a key feature of macular degeneration. ^{1 2 3 4 5}

How is the CG-P5 peptide drug different from other treatments for age-related macular degeneration?

The CG-P5 peptide drug is unique because it is designed to inhibit the complement system, which plays a role in the development of age-related macular degeneration (AMD). This approach targets both dry and wet forms of AMD by potentially preventing the underlying immune response that contributes to the disease, unlike other treatments that may focus on symptoms or different pathways. ^{1 2 6 7 8}

Research Team

Dr. Yong Ji Chung

Principal Investigator

Caregen Co. Ltd.

Eligibility Criteria

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

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Peptide redesign for inhibition of the complement system: Targeting age-related macular degeneration. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Avacincaptad pegol for geographic atrophy secondary to age-related macular degeneration: 18-month findings from the GATHER1 trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

The Need for Treatment of Neovascular Age-Related Macular Degeneration: A Study Based on the Polish National Registry. [2022]

4. England 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. [2021]

5. United States 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. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A Novel HDL-Mimetic Peptide HM-10/10 Protects RPE and Photoreceptors in Murine Models of Retinal Degeneration. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Synthesis and structural characterization of carboxyethylpyrrole-modified proteins: mediators of age-related macular degeneration. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Complement Factor P in choroidal neovascular membranes of patients with age-related macular degeneration. [2009]