Atrophic Age-related Macular Degeneration (AMD) Treated With Intravitreal Injections of Umbilical Cord Blood Platelet-rich Plasma (CB-PRP): a Pilot Study

Study Overview
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Brief Summary
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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)

Official Title
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Atrophic Age-related Macular Degeneration (AMD) Treated With Intravitreal Injections of Umbilical Cord Blood Platelet-rich Plasma (CB-PRP): a Pilot Study

Conditions
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Dry Age-related Macular Degeneration

Intervention / Treatment
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* Procedure: Intravitreal injection of CB-PRP


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization will take place by eye, each patient will have one eye treated and the contralateral subjected to sham. The treated eye will receive CB-PRP injections modulated differently over time in each of the sub-studies, i.e. monthly, bimonthly or quarterly, while the contralateral eye will receive a SHAM injection.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monthly injection<br>The patients will recive 12 intravitreal injections in one eye and 12 sham injections in the other eye each month | Procedure: Intravitreal injection of CB-PRP<br>* The procedure consists in a trans-scleral puncture to access the vitreous cavity, with subsequent injection of CB-PRP<br>* Other names: CB-PRP;|
| Experimental: Bimonthly injection<br>The patients will receive 6 intravitreal injections in one eye and 6 sham injections in the other eye each two months | Procedure: Intravitreal injection of CB-PRP<br>* The procedure consists in a trans-scleral puncture to access the vitreous cavity, with subsequent injection of CB-PRP<br>* Other names: CB-PRP;|
| Experimental: Quarterly injection<br>The patients will receive 4 intravitreal injections in one eye and 4 sham injections in the other eye each three months | Procedure: Intravitreal injection of CB-PRP<br>* The procedure consists in a trans-scleral puncture to access the vitreous cavity, with subsequent injection of CB-PRP<br>* Other names: CB-PRP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 year | 
| Autofluorescence atrophy area changes in treated eyes compared with sham group (1) | Stabilization of the enlargement of the hyperfluorescent area (atrophy enhancement) or at most a maximum increase of not more than 20% from the baseline | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ETDRS visual acuity | Increase of at least two lines from baseline measurement and/or to the contralateral untreated eye at 3 and 6, 12, months. | 1 year | 
| 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, months | 1 year | 
| Mean increase in retinal volumetrics | Mean increase, measured by high-resolution quantitative OCT, of at least 20% from baseline at 3 and 6, 12, months | 1 year | 
| 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, months. | 1 year | 
| Retinography of the ocular fundus | Change in ocular fundus | 1 year | 
| Incomplete retinal pigment epithelial (RPE) and outer retinal atrophy (iRORA) | Change during follow ups | 1 year | 
| Outer retinal atrophy (iRORA) | Change during follow ups | 1 year |