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).
Detailed description
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.
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
SINGLE (Subject)
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 | 24 months | 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 |
|---|---|---|
| ETDRS visual acuity | 24 months | 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 | 24 months | 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 | 24 months | Mean increase, measured by high-resolution quantitative OCT, of at least 20% from baseline at 3 and 6, 12, 24 months |
| Retinography of the ocular fundus | 24 months | Change in ocular fundus |
| Incomplete retinal pigment epithelial (RPE) and outer retinal atrophy (iRORA) | 24 months | Change during follow ups |
| Outer retinal atrophy (iRORA) | 24 months | Change during follow ups |
| Stabilization of the atrophy region of the EPR | 24 months | Stabilization in enface OCT with less than 20% increase from baseline, comparing it with the placebo group, at 3 and 6, 12,24 months. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of therapy safety | 24 months | 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, MD, PhD
Outcome results
None listed