Atrophic Age-related Macular Degeneration (AMD) Treated With Intravitreal Injections of Umbilical Cord Blood Platelet-rich Plasma (CB-PRP): a Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dry Age-related Macular Degeneration
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Autofluorescence atrophy area changes in treated eyes compared with sham group (1)
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
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)
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Autofluorescence atrophy area changes in treated eyes compared with sham group (1)
Time Frame: 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
Time Frame: 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 Outcomes
- Mean increase in retinal volumetrics(1 year)
- ETDRS visual acuity(1 year)
- Mean increase in ONL thickness and retinal volumetrics(1 year)
- Stabilization of the atrophy region of the EPR(1 year)
- Incomplete retinal pigment epithelial (RPE) and outer retinal atrophy (iRORA)(1 year)
- Retinography of the ocular fundus(1 year)
- Outer retinal atrophy (iRORA)(1 year)