Status:
RECRUITING
Age-related Macular Degeneration of Atrophic Type Treated With Umbilical Cord Blood Enriched With Platelet Plasma.
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Dry Age-related Macular Degeneration
Eligibility:
All Genders
65+ years
Phase:
NA
Brief 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...
Detailed Description
Patients will undergo intravitreal injections of CB-PRP (Cord Blood Platelet-rich Plasma) according to three different treatment regimens, and the efficacy and safety of CB-PRP in an in vitro model of...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Age \< 65 years
- Pregnancy
- Previous inflammatory/infectious events involving the eyes
- Eye trauma, diabetes, or disease potentially damaging to the visual system, even in the absence of impairment at the time of intake
- Previous intravitreal treatments.
- Refusal to sign informed consent.
Key Trial Info
Start Date :
July 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06536062
Start Date
July 20 2024
End Date
July 30 2026
Last Update
September 23 2025
Active Locations (1)
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1
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Rome, Italy, 00168