Age-related Macular Degeneration of Atrophic Type Treated With Umbilical Cord Blood Enriched With Platelet Plasma.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intravitreal injection of CB-PRP.
- Who it may be relevant to
- Registry conditions: Dry Age-related Macular Degeneration. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Age-related Macular Degeneration of Atrophic Type Treated With Intravitreal Injection of Umbilical Cord Blood Enriched With Platelet Plasma: Multicenter Study.
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).
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.
Interventions
- Procedure Intravitreal injection of CB-PRP
The procedure consists in a trans-scleral puncture to access the vitreous cavity, with subsequent injection of CB-PRP
Primary outcome measures
- Autofluorescence atrophy area changes in treated eyes compared with sham group [Time frame: 24 months]
Secondary outcome measures (7)
- ETDRS visual acuity [Time frame: 24 months]
- Mean increase in ONL thickness and retinal volumetrics [Time frame: 24 months]
- Mean increase in retinal volumetrics [Time frame: 24 months]
- Stabilization of the atrophy region of the EPR [Time frame: 24 months]
- Retinography of the ocular fundus [Time frame: 24 months]
- Incomplete retinal pigment epithelial (RPE) and outer retinal atrophy (iRORA) [Time frame: 24 months]
- Outer retinal atrophy (iRORA) [Time frame: 24 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome
Publications
- 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
Identifiers
NCT: NCT06536062 · 6848