Treatment of Dry Age-related Macular Degeneration with Intravitreal Umbilical Cord Blood Platelet-rich Plasma Injections Comparing Different Injection Schedules in a Multicenter Study

What this Trial Is About

Researchers are evaluating the effectiveness of intravitreal injections of Umbilical Cord Blood Platelet-rich Plasma CB-PRP for slowing or stabilizing the atrophic progression in people with dry Age-related Macular Degeneration AMD. This study aims to assess the safety and impact of different treatment schedules of CB-PRP on the retina, specifically focusing on photoreceptor responses in the macular area. Advanced retinal imaging will be used to monitor microanatomical changes as key indicators of treatment efficacy. Participants will receive one of three treatment regimens involving intravitreal injections of CB-PRP in one eye and sham injections in the other. The regimens include 12 monthly injections, 6 injections every two months, or 4 injections every three months. The procedure involves a trans-scleral puncture to deliver CB-PRP directly into the vitreous cavity. The study is randomized with single masking to compare the outcomes between treated and sham-injected eyes. During the 24-month study, participants will undergo regular assessments including retinal imaging and visual acuity tests. Researchers will measure changes in the area of atrophy using autofluorescence, retinal thickness, volumetrics, and signs of retinal pigment epithelial and outer retinal atrophy. Safety and treatment adherence will also be monitored throughout the study period to evaluate the long-term effects of CB-PRP injections.

Age-related Macular Degeneration of Atrophic Type Treated With Umbilical Cord Blood Enriched With Platelet Plasma.