Clinical trial NCT06536062: Age-related Macular Degeneration of Atrophic Type Treated With Umbilical Cord Blood Enriched With Platelet Plasma.
Official title: Age-related Macular Degeneration of Atrophic Type Treated With Intravitreal Injection of Umbilical Cord Blood Enriched With Platelet Plasma: Multicenter Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dry Age-related Macular Degeneration
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 36
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Autofluorescence atrophy area changes in treated eyes compared with sham group
timeFrame: 24 months
Secondary outcomes:
measure: ETDRS visual acuity
timeFrame: 24 months
measure: Mean increase in ONL thickness and retinal volumetrics
timeFrame: 24 months
measure: Mean increase in retinal volumetrics
timeFrame: 24 months
measure: Stabilization of the atrophy region of the EPR
timeFrame: 24 months
measure: Retinography of the ocular fundus
timeFrame: 24 months
measure: Incomplete retinal pigment epithelial (RPE) and outer retinal atrophy (iRORA)
timeFrame: 24 months
measure: Outer retinal atrophy (iRORA)
timeFrame: 24 months
Other outcomes:
measure: Evaluation of therapy safety
timeFrame: 24 months
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
References:
citation: Heier JS, Pieramici D, Chakravarthy U, Patel SS, Gupta S, Lotery A, Lad EM, Silverman D, Henry EC, Anderesi M, Tschosik EA, Gray S, Ferrara D, Guymer R; Chroma and Spectri Study Investigators. Visual Function Decline Resulting from Geographic Atrophy: Results from the Chroma and Spectri Phase 3 Trials. Ophthalmol Retina. 2020 Jul;4(7):673-688. doi: 10.1016/j.oret.2020.01.019. Epub 2020 Jan 31.
citation: Pfau M, Kunzel SH, Pfau K, Schmitz-Valckenberg S, Fleckenstein M, Holz FG. Multimodal imaging and deep learning in geographic atrophy secondary to age-related macular degeneration. Acta Ophthalmol. 2023 Dec;101(8):881-890. doi: 10.1111/aos.15796.