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

Not Applicable

Recruiting

• Conditions: Dry Age-related Macular Degeneration
• Interventions: Procedure: Intravitreal injection of CB-PRP

• Registration Number: NCT05706896
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-14
• Study First Submitted: 2023-01-09
• Study First Submitted QC: 2023-01-23
• Study First Posted: 2023-01-31
• Primary Completion: 2023-06-09
• Status Verified: 2023-12
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Study Completion: 2025-06-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monthly injection	Intravitreal injection of CB-PRP	The patients will recive 12 intravitreal injections in one eye and 12 sham injections in the other eye each month
Quarterly injection	Intravitreal injection of CB-PRP	The patients will receive 4 intravitreal injections in one eye and 4 sham injections in the other eye each three months
Bimonthly injection	Intravitreal injection of CB-PRP	The patients will receive 6 intravitreal injections in one eye and 6 sham injections in the other eye each two months

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Mean increase in retinal volumetrics	1 year	Mean increase, measured by high-resolution quantitative OCT, of at least 20% from baseline at 3 and 6, 12, months
ETDRS visual acuity	1 year	Increase of at least two lines from baseline measurement and/or to the contralateral untreated eye at 3 and 6, 12, months.
Mean increase in ONL thickness and retinal volumetrics	1 year	Mean increase, measured by high-resolution quantitative OCT, of at least 20% from baseline at 3 and 6, 12, months
Stabilization of the atrophy region of the EPR	1 year	Stabilization in enface OCT with less than 20% increase from baseline, comparing it with the placebo group, at 3 and 6, 12, months.
Outer retinal atrophy (iRORA)	1 year	Change during follow ups
Incomplete retinal pigment epithelial (RPE) and outer retinal atrophy (iRORA)	1 year	Change during follow ups
Retinography of the ocular fundus	1 year	Change in ocular fundus

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Rome, Italy