RecruitingNot ApplicableNCT06536062

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

Age-related Macular Degeneration of Atrophic Type Treated With Intravitreal Injection of Umbilical Cord Blood Enriched With Platelet Plasma: Multicenter Study.


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

36 participants

Start Date

Jul 20, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 65 Years

Inclusion Criteria5

  • 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 Criteria6

  • 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.

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Interventions

PROCEDUREIntravitreal injection of CB-PRP

The procedure consists in a trans-scleral puncture to access the vitreous cavity, with subsequent injection of CB-PRP


Locations(1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Rome, Italy

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NCT06536062


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