Age-related Macular Degeneration of Atrophic Type Treated With Umbilical Cord Blood Enriched With Platelet Plasma. (M-CORD IV)

September 17, 2025 updated by: Savastano Maria Cristina, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
    • Rome
      • Rome, Rome, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
        • Contact:
        • Principal Investigator:
          • Maria Cristina Savastano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Monthly injection
The patients will recive 12 intravitreal injections in one eye and 12 sham injections in the other eye each month
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
Experimental: Bimonthly injection
The patients will receive 6 intravitreal injections in one eye and 6 sham injections in the other eye each two months
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
Experimental: Quarterly injection
The patients will receive 4 intravitreal injections in one eye and 4 sham injections in the other eye each three months
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
24 months
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
24 months
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
24 months
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.
24 months
Retinography of the ocular fundus
Time Frame: 24 months
Change in ocular fundus
24 months
Incomplete retinal pigment epithelial (RPE) and outer retinal atrophy (iRORA)
Time Frame: 24 months
Change during follow ups
24 months
Outer retinal atrophy (iRORA)
Time Frame: 24 months
Change during follow ups
24 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 6848

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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