Actively Recruiting
Pilot Study of Intravitreal Umbilical Cord Blood Platelet-rich Plasma Injections for Treating Dry Age-related Macular Degeneration in Adults 65 and Older
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-09-23
36
Participants Needed
1
Research Sites
139 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of intravitreal injections of Umbilical Cord Blood Platelet-rich Plasma CB-PRP in people with dry Age-related Macular Degeneration AMD. The goal is to see if these injections can reduce or stabilize the progression of atrophy caused by this eye condition. This pilot study is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS and involves participants aged 65 years and older with bilateral dry-AMD. Participants will receive different schedules of intravitreal injections of CB-PRP in one eye and sham injections in the other eye. Three groups are studied one group will get 12 injections monthly, another group will get 6 injections every two months, and the last group will get 4 injections every three months. Each injection involves a trans-scleral puncture to access the vitreous cavity, followed by the injection of CB-PRP. During the study, participants will be monitored for changes in the area of atrophy in their treated eyes compared to the sham-treated eyes over one year. Researchers will assess visual acuity using ETDRS charts, retinal thickness and volume, and the stability of the atrophy region using specialized imaging techniques. Regular eye exams, retinography, and evaluations for retinal pigment epithelial and outer retinal atrophy are included to measure safety and treatment effects throughout the study period.
CONDITIONS
Brief Title
Atrophic Age-related Macular Degeneration Treated With Intravitreal Injections of Umbilical Cord Blood Platelet-rich Plasma
Research Team
M
Maria Cristina Savastano
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