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NCT Number: NCT06536062

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

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).

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

Location status: Recruiting

Location contact

Maria Cristina Savastano

CONTACT

[email protected]

+39 3384443002

Maria Cristina Savastano

PRINCIPAL_INVESTIGATOR

About this study

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 lipopolysaccharide (LPS)-induced degeneration in hTERT RPE-1 and ARPE-19 model cell lines derived from retinal pigmented epithelium (RPE) will be evaluated.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intravitreal injection of CB-PRP

Procedure

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

Primary outcomes

  1. Autofluorescence atrophy area changes in treated eyes compared with sham group

    Time frame: 24 months

    Stabilization of enlargement of hypoautofluorescent area (atrophy) or at most a maximum increase of no more than 20% compared with baseline in treated subjects compared with placebo group from baseline until follow-ups

Secondary outcomes

  1. ETDRS visual acuity

    Time frame: 24 months

    Increase of at least two lines from baseline measurement and/or to the contralateral untreated eye at 3 and 6, 12,24 months.

  2. Mean increase in ONL thickness and retinal volumetrics

    Time frame: 24 months

    Mean increase, measured by high-resolution quantitative OCT, of at least 20% from baseline at 3 and 6, 12, 24 months

  3. Mean increase in retinal volumetrics

    Time frame: 24 months

    Mean increase, measured by high-resolution quantitative OCT, of at least 20% from baseline at 3 and 6, 12, 24 months

  4. Stabilization of the atrophy region of the EPR

    Time frame: 24 months

    Stabilization in enface OCT with less than 20% increase from baseline, comparing it with the placebo group, at 3 and 6, 12,24 months.

  5. Retinography of the ocular fundus

    Time frame: 24 months

    Change in ocular fundus

  6. Incomplete retinal pigment epithelial (RPE) and outer retinal atrophy (iRORA)

    Time frame: 24 months

    Change during follow ups

  7. Outer retinal atrophy (iRORA)

    Time frame: 24 months

    Change during follow ups

Other outcomes

  1. Evaluation of therapy safety

    Time frame: 24 months

    Evaluation of major ocular adverse events (bacterial or fungal septic endophthalmitis, retinal detachment, vitreous proliferative-fibrotic reaction with retinal traction, secondary glaucoma, phthisis bulbs, iris rubeosis), studied at slit-lamp evaluation in the anterior and posterior chambers.

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Cristina Savastano, MD, PhD

CONTACT

[email protected]

0630151

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: M-CORD IV

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 2, 2024
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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