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NCT Number: NCT05706896

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

Conditions

Dry Age-related Macular Degeneration

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

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

Other names: CB-PRP

Primary outcomes

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

    Time frame: 1 year

    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

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

    Time frame: 1 year

    Stabilization of the enlargement of the hyperfluorescent area (atrophy enhancement) or at most a maximum increase of not more than 20% from the baseline

Secondary outcomes

  1. ETDRS visual acuity

    Time frame: 1 year

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

  2. Mean increase in ONL thickness and retinal volumetrics

    Time frame: 1 year

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

  3. Mean increase in retinal volumetrics

    Time frame: 1 year

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

  4. Stabilization of the atrophy region of the EPR

    Time frame: 1 year

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

  5. Retinography of the ocular fundus

    Time frame: 1 year

    Change in ocular fundus

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

    Time frame: 1 year

    Change during follow ups

  7. Outer retinal atrophy (iRORA)

    Time frame: 1 year

    Change during follow ups

Other outcomes

  1. Evaluation of therapy safety

    Time frame: 1 year

    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

CONTACT

[email protected]

+390630155701

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: CORD-IV

Important dates

Study start
2022
Primary completion
2023
Study completion
2026
First posted
Jan 31, 2023
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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