NCT06787482RecruitingPhase 1/2
Evaluating a New Peptide Therapy for Retinal Diseases: AMD, Diabetic Retinopathy, and Dystrophies
Open Label, Interventional Single Arm Study Evaluating a New Peptide Therapy for Retinal Diseases: AMD, Diabetic Retinopathy, and Dystrophies
Source: ClinicalTrials.gov · Last updated 25 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 16 Jan 2025
- Start date
- 12 Nov 2024
- Primary completion date
- Jun 2025
- Lead sponsor
- Ace Cells Lab Limited
- NCT number
- NCT06787482
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 100
- From 12 Nov 2024 to the primary completion date, Jun 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- • 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.
Who the study is looking for
- • 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
Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dr. Seif Clinic Coordinator of this site? Confirm its status | Cairo | Egypt | Recruiting |
| British Center for Regeerative medicne (Cairo) Coordinator of this site? Confirm its status | Giza | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.