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).
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
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
Parallel
Intravitreal injection of CB-PRP
Procedure/SurgeryThe procedure consists in a trans-scleral puncture to access the vitreous cavity, with subsequent injection of CB-PRP
Autofluorescence atrophy area changes in treated eyes compared with sham group
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
ETDRS visual acuity
Increase of at least two lines from baseline measurement and/or to the contralateral untreated eye at 3 and 6, 12,24 months.
Mean increase in ONL thickness and retinal volumetrics
Mean increase, measured by high-resolution quantitative OCT, of at least 20% from baseline at 3 and 6, 12, 24 months
Mean increase in retinal volumetrics
Mean increase, measured by high-resolution quantitative OCT, of at least 20% from baseline at 3 and 6, 12, 24 months
Stabilization of the atrophy region of the EPR
Stabilization in enface OCT with less than 20% increase from baseline, comparing it with the placebo group, at 3 and 6, 12,24 months.
Evaluation of therapy safety
Evaluation of major ocular adverse events (bacterial or fungal septic endophthalmitis, retinal detachment, vitreous proliferative-fibrotic reaction with retinal traction, secondary glaucoma, phthisis bulbs, iris rubeosis), studied at slit-lamp evaluation in the anterior and posterior chambers.
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