Evaluating a New Peptide Therapy for Retinal Diseases: AMD, Diabetic Retinopathy, and Dystrophies

Sponsor
Ace Cells Lab Limited
Study ID
NCT06787482
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • ACE Retino — DIETARY_SUPPLEMENT
    1 ml sublingually self administer / 4 times/day for 6 months

Study Details

Summary of the Study This clinical trial evaluates a novel peptide-based therapy for treating retinal dystrophies, age-related macular degeneration (AMD), and diabetic retinopathy (DR). The therapy consists of peptides derived from fetal tissues, mesenchymal stem cells (MSCs), and bioactive growth factors, administered sublingually for systemic absorption. Study Objectives: Primary Objectives: Assess safety and tolerability, and evaluate the therapy's effects on retinal function and structure. Secondary Objectives: Explore improvements in visual acuity, retinal thickness, vascular health, and disease biomarkers. Study Design: Type: Open-label, single-arm interventional study. Duration: 12 months. Participants: 150 adults, divided into three cohorts: Retinal dystrophies. AMD (dry and wet forms). DR (moderate NPDR and PDR). Intervention: A sublingual solution containing peptides and growth factors, taken 4 times daily. Outcome Measures: Primary Outcomes: Safety (adverse events) and tolerability (treatment adherence). Secondary Outcomes: Functional: Visual acuity and field sensitivity improvements. Structural: Retinal thickness and vascular health. Biomarkers: Serum VEGF, oxidative stress, and inflammatory markers. Study Procedures: Monthly follow-ups for safety monitoring, vision tests, retinal imaging (OCT, FA), and blood biomarker analysis. Comprehensive evaluations at baseline, 6 months, and 12 months. Significance: The study aims to provide an innovative, non-invasive treatment for debilitating retinal conditions, potentially improving vision and retinal health through systemic therapy.

Key Dates

First listed
Jan 22, 2025
Start date
Nov 12, 2024
Status verified
Jan 2025
Primary completion
Jun 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: administer 1 ml of Ace Retino 4 times daily for 6 months,safety evaluation
    Primary Objective: Evaluate the safety and tolerability of ACE Retino in individuals with RP.
  • Experimental: test efficacy for ACE Retino 1 ml 4times daily sublingual for 6 months
    Assess the efficacy of ACE Retino in improving retinal structure and function. Explore the potential for photoreceptor and retinal pigment epithelial (RPE) regeneration.

Primary Outcome Measure

change in BVCA [ Time Frame: 3 months ]

Central Contacts

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