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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).
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.
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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 | 24 months |
| 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, 12,24 months. | 24 months |
| 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. | 24 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Cristina Savastano, MD, PhD | Contact | 0630151 | mariacristina.savastano@policlinicogemelli.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | Rome | Rome | 00168 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32199866 | Background | 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. | |
| 37933610 |
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Mean increase, measured by high-resolution quantitative OCT, of at least 20% from baseline at 3 and 6, 12, 24 months
| 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 | 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. | 24 months |
| Retinography of the ocular fundus | Change in ocular fundus | 24 months |
| Incomplete retinal pigment epithelial (RPE) and outer retinal atrophy (iRORA) | Change during follow ups | 24 months |
| Outer retinal atrophy (iRORA) | Change during follow ups | 24 months |
| Background |
| 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. |