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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS36 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dry Age-related Macular Degeneration

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

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 1 year

Secondary Outcomes

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.

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 1 year

Retinography of the ocular fundus

Change in ocular fundus

Central Contacts

Maria Cristina Savastano

CONTACT

+390630155701 mariacristina.savastano@policlinicogemelli.it

Data from ClinicalTrials.gov

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