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

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

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

Contacts and Locations

Study Locations

• Italy
  • 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: 65 years and older (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: None (Open Label)

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; Other Names: 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; Other Names: 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; Other Names: 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	1 year
Autofluorescence atrophy area changes in treated eyes compared with sham group (1)	Stabilization of the enlargement of the hyperfluorescent area (atrophy enhancement) or at most a maximum increase of not more than 20% from the baseline	1 year

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, months.	1 year
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, months	1 year
Mean increase in retinal volumetrics	Mean increase, measured by high-resolution quantitative OCT, of at least 20% from baseline at 3 and 6, 12, months	1 year
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, months.	1 year
Retinography of the ocular fundus	Change in ocular fundus	1 year
Incomplete retinal pigment epithelial (RPE) and outer retinal atrophy (iRORA)	Change during follow ups	1 year
Outer retinal atrophy (iRORA)	Change during follow ups	1 year

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.	1 year

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2022
• Primary Completion (Actual): June 9, 2023
• Study Completion (Estimated): June 10, 2025

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: January 23, 2023
• First Posted (Actual): January 31, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: 4995

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