Open-Label Study of ACE Retino, a New Peptide Therapy for Retinitis Pigmentosa, Age-Related Macular Degeneration, and Diabetic Retinopathy Evaluating Safety, Tolerability, and Effects on Retinal Health over 12 Months

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.

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