Dry Age-related Macular Degeneration
Conditions
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)
Interventions
PROCEDUREIntravitreal injection of CB-PRP
The procedure consists in a trans-scleral puncture to access the vitreous cavity, with subsequent injection of CB-PRP
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Autofluorescence atrophy area changes in treated eyes compared with sham group (1) | 1 year | Stabilization of the enlargement of the hyperfluorescent area (atrophy enhancement) or at most a maximum increase of not more than 20% from the baseline |
| Autofluorescence atrophy area changes in treated eyes compared with sham group | 1 year | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean increase in ONL thickness and retinal volumetrics | 1 year | Mean increase, measured by high-resolution quantitative OCT, of at least 20% from baseline at 3 and 6, 12, months |
| Mean increase in retinal volumetrics | 1 year | Mean increase, measured by high-resolution quantitative OCT, of at least 20% from baseline at 3 and 6, 12, months |
| Stabilization of the atrophy region of the EPR | 1 year | Stabilization in enface OCT with less than 20% increase from baseline, comparing it with the placebo group, at 3 and 6, 12, months. |
| Incomplete retinal pigment epithelial (RPE) and outer retinal atrophy (iRORA) | 1 year | Change during follow ups |
| Outer retinal atrophy (iRORA) | 1 year | Change during follow ups |
| Retinography of the ocular fundus | 1 year | Change in ocular fundus |
| ETDRS visual acuity | 1 year | Increase of at least two lines from baseline measurement and/or to the contralateral untreated eye at 3 and 6, 12, months. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of therapy safety | 1 year | 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. |
Countries
Italy
Contacts
Primary ContactMaria Cristina Savastano
Outcome results
None listed