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

NCT05706896 | Recruiting

• 1 other identifier: 4995
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Dry Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• ETDRS visual acuity

  1 year

• Mean increase in ONL thickness and retinal volumetrics

  1 year

• Mean increase in retinal volumetrics

  1 year

• Stabilization of the atrophy region of the EPR

  1 year

• Retinography of the ocular fundus

  1 year

Other Outcomes (1)

• Evaluation of therapy safety

  1 year

Study Arms (3)

Monthly injection

EXPERIMENTAL

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

Bimonthly injection

EXPERIMENTAL

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

Quarterly injection

EXPERIMENTAL

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

Interventions

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

Also known as: CB-PRP

Bimonthly injection; Monthly injection; Quarterly injection

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

Study Officials

• Maria Cristina savastano

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Cristina Savastano

CONTACT

+390630155701; mariacristina.savastano@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization will take place by eye, each patient will have one eye treated and the contralateral subjected to sham. The treated eye will receive CB-PRP injections modulated differently over time in each of the sub-studies, i.e. monthly, bimonthly or quarterly, while the contralateral eye will receive a SHAM injection.

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 31, 2023
• Study Start: December 14, 2022
• Primary Completion: June 9, 2023
• Study Completion: February 10, 2026
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)