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

Condition(s) studied

Investigational drug(s) / intervention(s)

ACE Retino: 1 ml sublingually self administer / 4 times/day for 6 months

Study summary

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.

Eligibility

Primary outcome measure(s)

• change in BVCA — 3 months
  change in BCVA (best-corrected visual acuity). The calculation is based on detecting a clinically meaningful improvement in BCVA using a paired design (before and after treatment within the same subjects).

Trial sites (2)

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