Age-related Macular Degeneration of Atrophic Type Treated With Umbilical Cord Blood Enriched With Platelet 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).

Patients will undergo intravitreal injections of CB-PRP (Cord Blood Platelet-rich Plasma) according to three different treatment regimens, and the efficacy and safety of CB-PRP in an in vitro model of lipopolysaccharide (LPS)-induced degeneration in hTERT RPE-1 and ARPE-19 model cell lines derived from retinal pigmented epithelium (RPE) will be evaluated. The purpose of this study is to evaluate the safety and efficacy of different temporal regimens of intravitreal administration of CB-PRP and the response of photoreceptors in the macular region in dry-AMD. Microanatomical changes in the retina induced by intravitreal CB-PRP therapy and measured by advanced retinal imaging techniques will be evaluated as an important signal of efficacy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

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, 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: 24 months

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, 12,24 months.

Time frame: 24 months

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, 24 months

Time frame: 24 months

Mean increase in retinal volumetrics

Mean increase, measured by high-resolution quantitative OCT, of at least 20% from baseline at 3 and 6, 12, 24 months

Time frame: 24 months

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, 12,24 months.

Time frame: 24 months

Retinography of the ocular fundus

Change in ocular fundus

Time frame: 24 months

Incomplete retinal pigment epithelial (RPE) and outer retinal atrophy (iRORA)

Change during follow ups

Time frame: 24 months

Central Contacts

Maria Cristina Savastano, MD, PhD

CONTACT

0630151 mariacristina.savastano@policlinicogemelli.it

Data from ClinicalTrials.gov

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