Age-related Macular Degeneration of Atrophic Type Treated With Intravitreal Injection of Umbilical Cord Blood Enriched With Platelet Plasma: Multicenter Study.
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The objective of the study will be to evaluate the efficacy of intravitreal injections of Umbilical Cord Blood Platelet-rich Plasma (CB-PRP) in order to reduce or stabilize the atrophic progression in dry Age-related Macular Degeneration (AMD).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:
• Age ≥65 years
• Bilateral dry-AMD
• ETDRS-corrected visual acuity between (or equal to) 1/10 and 4/10
• No concomitant ocular pathology (e.g., Glaucoma, amblyopia) or systemic pathology that would result in a BIAS for primary goal assessment
• Signature of informed consent
Locations
Other Locations
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITING
Rome
Contact Information
Primary
Maria Cristina Savastano, MD, PhD
mariacristina.savastano@policlinicogemelli.it
0630151
Time Frame
Start Date: 2024-07-20
Estimated Completion Date: 2026-07-30
Participants
Target number of participants: 36
Treatments
Experimental: Monthly injection
The patients will recive 12 intravitreal injections in one eye and 12 sham injections in the other eye each month
Experimental: Bimonthly injection
The patients will receive 6 intravitreal injections in one eye and 6 sham injections in the other eye each two months
Experimental: Quarterly injection
The patients will receive 4 intravitreal injections in one eye and 4 sham injections in the other eye each three months
Related Therapeutic Areas
Sponsors
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS