Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00168, Italy
Location status: Recruiting
Location contact
Maria Cristina Savastano
CONTACT
Maria Cristina Savastano
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06536062
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).
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Not applicable
Rome, 00168, Italy
Location status: Recruiting
Maria Cristina Savastano
CONTACT
Maria Cristina Savastano
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The procedure consists in a trans-scleral puncture to access the vitreous cavity, with subsequent injection of CB-PRP
Time frame: 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
Time frame: 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.
Time frame: 24 months
Mean increase, measured by high-resolution quantitative OCT, of at least 20% from baseline at 3 and 6, 12, 24 months
Time frame: 24 months
Mean increase, measured by high-resolution quantitative OCT, of at least 20% from baseline at 3 and 6, 12, 24 months
Time frame: 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.
Time frame: 24 months
Change in ocular fundus
Time frame: 24 months
Change during follow ups
Time frame: 24 months
Change during follow ups
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
Age-related Macular Degeneration of Atrophic Type Treated With Intravitreal Injection of Umbilical Cord Blood Enriched With Platelet Plasma: Multicenter Study.
Acronym: M-CORD IV
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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