New peptide therapy for retinal diseases
Open Label, Interventional Single Arm Study Evaluating a New Peptide Therapy for Retinal Diseases: AMD, Diabetic Retinopathy, and Dystrophies
PHASE1; PHASE2 · Ace Cells Lab Limited · NCT06787482
This study is testing a new peptide therapy to see if it can help adults with retinal diseases like age-related macular degeneration and diabetic retinopathy improve their vision and eye health.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Ace Cells Lab Limited (industry) |
| Locations | 2 sites (Cairo and 1 other locations) |
| Trial ID | NCT06787482 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a novel peptide-based therapy aimed at treating retinal dystrophies, age-related macular degeneration (AMD), and diabetic retinopathy (DR). The therapy involves sublingual administration of peptides derived from fetal tissues and mesenchymal stem cells, combined with bioactive growth factors. The study is designed as an open-label, single-arm intervention with 150 adult participants, focusing on safety, tolerability, and improvements in retinal function and structure over a 12-month period.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-65 with a confirmed diagnosis of retinal dystrophies, AMD, or DR and stable ocular conditions.
Not a fit: Patients with significant ocular comorbidities, recent ocular surgery, or uncontrolled systemic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve vision and retinal health for patients suffering from these debilitating conditions.
How similar studies have performed: While peptide therapies are a novel approach in this context, similar studies have shown promise in other areas of regenerative medicine.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Adults aged 18-65 years with a confirmed genetic or clinical diagnosis of RP. * Visual acuity of ≥1/60 in at least one eye. * Stable ocular and systemic condition over the past six months. * Ability to provide written informed consent Exclusion Criteria: * • Significant ocular comorbidities (e.g., advanced glaucoma, diabetic retinopathy). * Recent ocular surgery (within six months) or current use of investigational drugs. * Systemic conditions affecting study outcomes (e.g., uncontrolled diabetes, autoimmune diseases). * Pregnancy or lactation.
Where this trial is running
Cairo and 1 other locations
- Dr. Seif Clinic — Cairo, Egypt (RECRUITING)
- British Center for Regeerative medicne (Cairo) — Giza, Egypt (RECRUITING)
Study contacts
- Principal investigator: Dr. Passant Sayed Saif, PhD ophthalmology — Associate prof of Ophthalmology Misr University for science and technology
- Study coordinator: Dr. Alaa Abdelkairm Mohammed, MRCPUK Endocrinology
- Email: dralaakarim@gmail.com
- Phone: +447473922553
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Retinitis Pigmentosa, Age Related Macular Degeneration, Diabetic Retinopathy