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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monthly injection | Experimental | The patients will recive 12 intravitreal injections in one eye and 12 sham injections in the other eye each month |
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| Bimonthly injection | Experimental | The patients will receive 6 intravitreal injections in one eye and 6 sham injections in the other eye each two months |
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| Quarterly injection | Experimental | The patients will receive 4 intravitreal injections in one eye and 4 sham injections in the other eye each three months |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravitreal injection of CB-PRP | Procedure | The procedure consists in a trans-scleral puncture to access the vitreous cavity, with subsequent injection of CB-PRP |
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| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Cristina Savastano | Contact | +390630155701 | mariacristina.savastano@policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| Maria Cristina savastano | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | Rome | 00168 | Italy |
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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.
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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 |