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

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: Recruiting
• Conditions: Dry Age-related Macular Degeneration
• Intervention / Treatment: Procedure: Intravitreal injection of CB-PRP

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: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Cristina Savastano, MD, PhD; Phone Number: 0630151; Email: mariacristina.savastano@policlinicogemelli.it

Study Locations

• Italy
  • Rome
    • Rome, Rome, Italy, 00168
      • Recruiting
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
      • Contact: Maria Cristina Savastano; Phone Number: +39 3384443002; Email: mariacristina.savastano@unicatt.it
      • Principal Investigator: Maria Cristina Savastano

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Autofluorescence atrophy area changes in treated eyes compared with sham group	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

Outcome Measure	Measure Description	Time Frame
ETDRS visual acuity	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	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	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	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	Change in ocular fundus	24 months
Incomplete retinal pigment epithelial (RPE) and outer retinal atrophy (iRORA)	Change during follow ups	24 months
Outer retinal atrophy (iRORA)	Change during follow ups	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of therapy safety	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

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Publications and helpful links

General Publications

• Heier JS, Pieramici D, Chakravarthy U, Patel SS, Gupta S, Lotery A, Lad EM, Silverman D, Henry EC, Anderesi M, Tschosik EA, Gray S, Ferrara D, Guymer R; Chroma and Spectri Study Investigators. Visual Function Decline Resulting from Geographic Atrophy: Results from the Chroma and Spectri Phase 3 Trials. Ophthalmol Retina. 2020 Jul;4(7):673-688. doi: 10.1016/j.oret.2020.01.019. Epub 2020 Jan 31.
• Pfau M, Kunzel SH, Pfau K, Schmitz-Valckenberg S, Fleckenstein M, Holz FG. Multimodal imaging and deep learning in geographic atrophy secondary to age-related macular degeneration. Acta Ophthalmol. 2023 Dec;101(8):881-890. doi: 10.1111/aos.15796.

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: July 19, 2024
• First Submitted That Met QC Criteria: July 31, 2024
• First Posted (Actual): August 2, 2024

Study Record Updates

• Last Update Posted (Estimated): September 23, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID 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