Age-related Macular Degeneration of Atrophic Type Treated With Umbilical Cord Blood Enriched With Platelet Plasma.
NCT ID: NCT06536062
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
36 participants
INTERVENTIONAL
2024-07-20
2026-07-30
Brief Summary
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Detailed Description
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The purpose of this study is to evaluate the safety and efficacy of different temporal regimens of intravitreal administration of CB-PRP and the response of photoreceptors in the macular region in dry-AMD. Microanatomical changes in the retina induced by intravitreal CB-PRP therapy and measured by advanced retinal imaging techniques will be evaluated as an important signal of efficacy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Monthly injection
The patients will recive 12 intravitreal injections in one eye and 12 sham injections in the other eye each month
Intravitreal injection of CB-PRP
The procedure consists in a trans-scleral puncture to access the vitreous cavity, with subsequent injection of CB-PRP
Bimonthly injection
The patients will receive 6 intravitreal injections in one eye and 6 sham injections in the other eye each two months
Intravitreal injection of CB-PRP
The procedure consists in a trans-scleral puncture to access the vitreous cavity, with subsequent injection of CB-PRP
Quarterly injection
The patients will receive 4 intravitreal injections in one eye and 4 sham injections in the other eye each three months
Intravitreal injection of CB-PRP
The procedure consists in a trans-scleral puncture to access the vitreous cavity, with subsequent injection of CB-PRP
Interventions
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Intravitreal injection of CB-PRP
The procedure consists in a trans-scleral puncture to access the vitreous cavity, with subsequent injection of CB-PRP
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
65 Years
ALL
No
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Savastano Maria Cristina
MD, PhD
Locations
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Rome, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Heier JS, Pieramici D, Chakravarthy U, Patel SS, Gupta S, Lotery A, Lad EM, Silverman D, Henry EC, Anderesi M, Tschosik EA, Gray S, Ferrara D, Guymer R; Chroma and Spectri Study Investigators. Visual Function Decline Resulting from Geographic Atrophy: Results from the Chroma and Spectri Phase 3 Trials. Ophthalmol Retina. 2020 Jul;4(7):673-688. doi: 10.1016/j.oret.2020.01.019. Epub 2020 Jan 31.
Pfau M, Kunzel SH, Pfau K, Schmitz-Valckenberg S, Fleckenstein M, Holz FG. Multimodal imaging and deep learning in geographic atrophy secondary to age-related macular degeneration. Acta Ophthalmol. 2023 Dec;101(8):881-890. doi: 10.1111/aos.15796.
Other Identifiers
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6848
Identifier Type: -
Identifier Source: org_study_id
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