Tests a sublingual peptide solution in adults with certain retinal eye diseases
Tests a peptide solution taken under the tongue in adults with retinal eye diseases.
Plain-language title generated from the registry record
Registry title: Evaluating a New Peptide Therapy for Retinal Diseases: AMD, Diabetic Retinopathy, and Dystrophies
Key facts
- Where
- Cairo and Giza, EgyptSee the 2 sites
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18-65 with a confirmed genetic or clinical diagnosis of retinitis pigmentosa (RP), whose eye and general health have been stable for six months.
- Age
- 18 to 65 years
- Sex
- All sexes can join.
- Disease stage
- Retinitis pigmentosa (RP) confirmed by a genetic or clinical diagnosis, with visual acuity of at least 1/60 in at least one eye.
- Earlier treatment
- No eye surgery in the past six months and no current use of investigational drugs.
Main reasons for not taking part
- Significant other eye diseases, for example advanced glaucoma or diabetic retinopathy
- Eye surgery within the past six months or current use of investigational drugs
- Conditions affecting study results, for example uncontrolled diabetes or autoimmune diseases
- Pregnancy or breastfeeding
Read by machine on 9 November 2026.
Where in Egypt
- Dr. Seif ClinicCairo, EgyptContact: Dr. Mohammed Yasser Sayed Saif, PhD Ophthalmology, professorTaking people
- British Center for Regeerative medicne (Cairo)Giza, EgyptContact: Dr. Alaa Abdelkarim Mohammed, MRCPUK EndocrinologyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Ace Cells Lab Limited
- Trial code
- NCT06787482
- Record updated
- 25 April 2025
- Original description
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.Read full original descriptionShow less
Open Label, Interventional Single Arm Study Evaluating a New Peptide Therapy for Retinal Diseases: AMD, Diabetic Retinopathy, and Dystrophies
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.
Inclusion: • 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: • 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.