Actively Recruiting
Open Label, Interventional Single Arm Study Evaluating a New Peptide Therapy for Retinal Diseases: AMD, Diabetic Retinopathy, and Dystrophies
Led by Ace Cells Lab Limited · Updated on 2025-04-25
100
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
Sponsors
A
Ace Cells Lab Limited
Lead Sponsor
E
European Wellness Academy
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new peptide-based therapy for retinal dystrophies, age-related macular degeneration (AMD), and diabetic retinopathy (DR). The study aims to assess the safety and tolerability of this therapy, as well as its effects on retinal function and structure. This open-label, single-arm study also explores improvements in vision, retinal thickness, vascular health, and disease biomarkers in affected adults. The therapy involves a sublingual solution containing peptides derived from fetal tissues, mesenchymal stem cells, and bioactive growth factors. Participants self-administer 1 ml of this solution four times daily for six months. The study includes monthly visits for safety monitoring, vision testing, retinal imaging, and blood tests. Comprehensive evaluations occur at the start, midpoint, and end of the 12-month study period. Participants will undergo regular vision assessments, retinal imaging (including OCT and fluorescein angiography), and blood biomarker analysis to monitor treatment effects. Researchers will track safety through adverse event reports and treatment adherence. The primary outcome focuses on changes in best corrected visual acuity (BCVA) at three months, with additional measures of retinal thickness and vascular health. The total participation involves detailed monitoring over one year to evaluate this innovative therapy.
CONDITIONS
Brief Title
Evaluating a New Peptide Therapy for Retinal Diseases: AMD, Diabetic Retinopathy, and Dystrophies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18-65 years with a confirmed genetic or clinical diagnosis of retinitis pigmentosa (RP).
- Visual acuity of at least 1/60 in one eye.
- Stable ocular and systemic condition over the past six months.
- Ability to provide written informed consent.
You will not qualify if you...
- Significant ocular comorbidities such as advanced glaucoma or diabetic retinopathy.
- Recent ocular surgery within six months.
- Current use of investigational drugs.
- Systemic conditions affecting study outcomes like uncontrolled diabetes or autoimmune diseases.
- Pregnancy or lactation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants self-administer 1 ml of ACE Retino sublingually four times daily for 6 months to evaluate safety and effects on retinal structure and function.
Monthly visits for safety monitoring and ocular assessments
Duration - 6 months
Participants undergo comprehensive evaluations of retinal function, structure, and biomarkers to assess treatment effects and tolerability.
Midpoint visit at 3 months and end-of-study visit at 6 months
Trial Site Locations
Total: 2 locations
1
Dr. Seif Clinic
Cairo, Egypt
Actively Recruiting
2
British Center for Regeerative medicne (Cairo)
Giza, Egypt, !2112
Actively Recruiting
Research Team
D
Dr. Alaa Abdelkairm Mohammed, MRCPUK Endocrinology
D
Dr. Shireen Amer, M.Sc Occupational&industrial M
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here