Age-related Macular Degeneration of Atrophic Type Treated With Umbilical Cord Blood Enriched With Platelet Plasma.
- Conditions
- Dry Age-related Macular Degeneration
- Interventions
- Procedure: Intravitreal injection of CB-PRP
- Registration Number
- NCT06536062
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 36
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Quarterly injection Intravitreal injection of CB-PRP The patients will receive 4 intravitreal injections in one eye and 4 sham injections in the other eye each three months Bimonthly injection Intravitreal injection of CB-PRP The patients will receive 6 intravitreal injections in one eye and 6 sham injections in the other eye each two months Monthly injection Intravitreal injection of CB-PRP The patients will recive 12 intravitreal injections in one eye and 12 sham injections in the other eye each month
- Primary Outcome Measures
Name Time Method Autofluorescence atrophy area changes in treated eyes compared with sham group 24 months Stabilization of enlargement of hypoautofluorescent area (atrophy) or at most a maximum increase of no more than 20% compared with baseline in treated subjects compared with placebo group from baseline until follow-ups
- Secondary Outcome Measures
Name Time Method Outer retinal atrophy (iRORA) 24 months Change during follow ups
ETDRS visual acuity 24 months Increase of at least two lines from baseline measurement and/or to the contralateral untreated eye at 3 and 6, 12,24 months.
Stabilization of the atrophy region of the EPR 24 months Stabilization in enface OCT with less than 20% increase from baseline, comparing it with the placebo group, at 3 and 6, 12,24 months.
Mean increase in retinal volumetrics 24 months Mean increase, measured by high-resolution quantitative OCT, of at least 20% from baseline at 3 and 6, 12, 24 months
Retinography of the ocular fundus 24 months Change in ocular fundus
Mean increase in ONL thickness and retinal volumetrics 24 months Mean increase, measured by high-resolution quantitative OCT, of at least 20% from baseline at 3 and 6, 12, 24 months
Incomplete retinal pigment epithelial (RPE) and outer retinal atrophy (iRORA) 24 months Change during follow ups
Trial Locations
- Locations (1)
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
🇮🇹Rome, Italy