Actively Recruiting
Atrophic Age-related Macular Degeneration Treated With Intravitreal Injections of Umbilical Cord Blood Platelet-rich Plasma (CB-PRP): a Pilot Study
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-09-23
36
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 years
- Diagnosis of bilateral dry Age-related Macular Degeneration
- Corrected visual acuity between or equal to 1/10 and 4/10
- No other eye diseases such as glaucoma or amblyopia
- No systemic diseases that could affect study results
- Signed informed consent
You will not qualify if you...
- Age under 65 years
- Pregnancy
- Previous eye inflammation or infections
- Eye trauma, diabetes, or diseases that may harm the visual system
- Previous intravitreal treatments
- Refusal to sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months depending on injection schedule
Participants receive intravitreal injections of umbilical cord blood platelet-rich plasma (CB-PRP) or sham injections in one eye over the course of the study to treat atrophic age-related macular degeneration.
12 monthly, 6 bimonthly, or 4 quarterly injection visits depending on assigned treatment group
Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy, 00168
Actively Recruiting
Research Team
M
Maria Cristina Savastano
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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