Menu
Recruiting NCT05706896

Atrophic Age-related Macular Degeneration Treated With Intravitreal Injections of Umbilical Cord Blood Platelet-rich Plasma

No phase Interventional Dry Age-related Macular Degeneration

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intravitreal injection of CB-PRP.
Who it may be relevant to
Registry conditions: Dry Age-related Macular Degeneration. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Atrophic Age-related Macular Degeneration (AMD) Treated With Intravitreal Injections of Umbilical Cord Blood Platelet-rich Plasma (CB-PRP): a Pilot Study

Overview

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)

Interventions

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

Primary outcome measures

  • Autofluorescence atrophy area changes in treated eyes compared with sham group [Time frame: 1 year]
  • Autofluorescence atrophy area changes in treated eyes compared with sham group (1) [Time frame: 1 year]
Secondary outcome measures (7)
  • ETDRS visual acuity [Time frame: 1 year]
  • Mean increase in ONL thickness and retinal volumetrics [Time frame: 1 year]
  • Mean increase in retinal volumetrics [Time frame: 1 year]
  • Stabilization of the atrophy region of the EPR [Time frame: 1 year]
  • Retinography of the ocular fundus [Time frame: 1 year]
  • Incomplete retinal pigment epithelial (RPE) and outer retinal atrophy (iRORA) [Time frame: 1 year]
  • Outer retinal atrophy (iRORA) [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome

Identifiers

NCT: NCT05706896 · 4995

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗