Age-related Macular Degeneration of Atrophic Type Treated With Umbilical Cord Blood Enriched With Platelet Plasma. (M-CORD IV)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Dry Age-related Macular Degeneration

Treatments: Procedure: Intravitreal injection of CB-PRP

Study type: Interventional

Funder types: Other

Identifiers

NCT06536062

6848

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 3 patient groups

Monthly injection

Experimental group

Description:

The patients will recive 12 intravitreal injections in one eye and 12 sham injections in the other eye each month

Treatment:

Procedure: Intravitreal injection of CB-PRP

Bimonthly injection

Experimental group

Description:

The patients will receive 6 intravitreal injections in one eye and 6 sham injections in the other eye each two months

Treatment:

Procedure: Intravitreal injection of CB-PRP

Quarterly injection

Experimental group

Description:

The patients will receive 4 intravitreal injections in one eye and 4 sham injections in the other eye each three months

Treatment:

Procedure: Intravitreal injection of CB-PRP