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

NCT05706896

4995

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)

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: None (Open label)

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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