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

Официальное название

Age-related Macular Degeneration of Atrophic Type Treated With Intravitreal Injection of Umbilical Cord Blood Enriched With Platelet Plasma: Multicenter Study.

Обзор

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).

Подробное описание

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.

Вмешательства

• Процедура Intravitreal injection of CB-PRP
  The procedure consists in a trans-scleral puncture to access the vitreous cavity, with subsequent injection of CB-PRP

Первичные конечные точки

• Autofluorescence atrophy area changes in treated eyes compared with sham group [Срок оценки: 24 months]

Вторичные конечные точки (7)

• ETDRS visual acuity [Срок оценки: 24 months]
• Mean increase in ONL thickness and retinal volumetrics [Срок оценки: 24 months]
• Mean increase in retinal volumetrics [Срок оценки: 24 months]
• Stabilization of the atrophy region of the EPR [Срок оценки: 24 months]
• Retinography of the ocular fundus [Срок оценки: 24 months]
• Incomplete retinal pigment epithelial (RPE) and outer retinal atrophy (iRORA) [Срок оценки: 24 months]
• Outer retinal atrophy (iRORA) [Срок оценки: 24 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome

Публикации

• 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. PMID 32199866
• 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. PMID 37933610

Идентификаторы

NCT: NCT06536062 · 6848

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗