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

Part of paid clinical trials in Manchester, Connecticut.

Sponsor
Caregen Co. Ltd.
Study ID
NCT06132035
Phase
PHASE1
Status
Recruiting

Conditions

  • Age-related Wet Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CG-P5 peptide — DRUG
    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
  • Placebo — DRUG
    Patient will instill daily 1 package of Placebo eye drops in the study eye \[self-administered\] using the single use tear-off disposable packaging
  • Aflibercept Injection [Eylea] — DRUG
    Patient will receiver Eylea® (Aflibercept) intravitreal injection once in a month

Study Details

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

Key Dates

Start date
Dec 22, 2023
Status verified
Feb 2025
Primary completion
May 31, 2025
Completion
Aug 31, 2025

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CG-P5 peptide eye drops
  • Placebo Comparator: Placebo Eye drops
  • Active Comparator: Intravitreal injection of Eylea®

Primary Outcome Measure

The percentage of occurrence of Adverse Events (AE) [ Time Frame: Screening, Day 0, Day 28, Day 56 & Day 84 ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
CBCC Global Research Site:005ManchesterConnecticut06042-
CBCC Global Research Site:006Deerfield BeachFlorida33064-
CBCC Global Research Site:001AugustaGeorgia30909-
CBCC Global Research Site:004CarmelIndiana46290-
CBCC Global Research Site:003FargoNorth Dakota58104-
CBCC Global Research Site:002EriePennsylvania16507-
CBCC Global Research Site:007PhiladelphiaPennsylvania19141-

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