NCT06536062

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Jul 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Jul 2024Jul 2026

First Submitted

Initial submission to the registry

July 19, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

July 20, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 2, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

1.9 years

First QC Date

July 19, 2024

Last Update Submit

September 17, 2025

Conditions

Dry Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • ETDRS visual acuity

    24 months

  • Mean increase in ONL thickness and retinal volumetrics

    24 months

  • Mean increase in retinal volumetrics

    24 months

  • Stabilization of the atrophy region of the EPR

    24 months

  • Retinography of the ocular fundus

    24 months

  • +2 more secondary outcomes

Other Outcomes (1)

  • Evaluation of therapy safety

    24 months

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-PRPPROCEDURE

The procedure consists in a trans-scleral puncture to access the vitreous cavity, with subsequent injection of CB-PRP

Bimonthly injectionMonthly injectionQuarterly injection

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Rome, 00168, Italy

RECRUITING

Related Publications (2)

  • 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.

    PMID: 32199866BACKGROUND

  • 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.

    PMID: 37933610BACKGROUND

Central Study Contacts

Maria Cristina Savastano, MD, PhD

CONTACT

0630151mariacristina.savastano@policlinicogemelli.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

July 19, 2024

First Posted

August 2, 2024

Study Start

July 20, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 30, 2026

Last Updated

September 23, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)