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

Study acronym: Retino
StatusRecruiting
PhasePhase 1/2
Started
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Record status
This record was last updated April 25, 2025 (before its estimated June 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Interventions: ACE Retino (Dietary Supplement), ACE Retino (Dietary Supplement) to ACE Retino (Dietary Supplement)
    • Site contacts updated at 2 of 2 sites
    v4
  2. Phase: Phase 2 to Phase 1/2v3
  3. Collaborators expanded, about 3 wordsv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06787482
Lead Sponsor Ace Cells Lab Limited
Collaborators: European Wellness Academy
Conditions
(from sponsor)		 Retinitis Pigmentosa (RP), Age Related Macular Degeneration, Diabetic Retinopathy
Related terms Diabetic Retinopathy, Macular Degeneration, Retinitis Pigmentosa
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov