MedTrace Logo

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

NCT06787482 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-04-25

No results posted yet for this 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.

Conditions

Interventions

DIETARY_SUPPLEMENT

ACE Retino

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

Sponsors & Collaborators

  • European Wellness Academy

    collaborator INDUSTRY

  • Ace Cells Lab Limited

    lead INDUSTRY

Principal Investigators

  • Dr. Passant Sayed Saif, PhD ophthalmology · Associate prof of Ophthalmology Misr University for science and technology

  • Dr. Mohammed Yasser Sayed Saif, PhD Ophthalmology · Dean of NILES Prof of Ophthalmology Beni-Suef University

  • Dr. Alaa Abdelkarim Mohammed, MRCPUK Endocirnology · ACE Cells Lab Limited Chief Medical Consultant

  • Dr. Ahmed Tamer Sayed Saif, PhD Ophthalmology · Chairman of Ophthalmology department Associate prof of Ophthalmology Fayoum university

  • DR. Mike Chan, stem cells expert · European Wellness Academy

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-12
Primary Completion
2025-06-30
Completion
2025-12-31

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06787482 on ClinicalTrials.gov