Treatment for dry age-related macular degeneration using umbilical cord blood plasma
Age-related Macular Degeneration of Atrophic Type Treated With Intravitreal Injection of Umbilical Cord Blood Enriched With Platelet Plasma: Multicenter Study.
This study is testing if injections of umbilical cord blood plasma can help older adults with dry age-related macular degeneration slow down or improve their vision.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome, Rome) |
| Trial ID | NCT06536062 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy of intravitreal injections of Umbilical Cord Blood Platelet-rich Plasma (CB-PRP) to reduce or stabilize the progression of atrophic dry Age-related Macular Degeneration (AMD). Patients aged 65 and older with bilateral dry-AMD will receive CB-PRP injections following different treatment regimens. The study will assess the safety and effectiveness of these injections through advanced retinal imaging techniques and in vitro models. The goal is to observe microanatomical changes in the retina and the response of photoreceptors in the macular region.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 65 and older with bilateral dry AMD and specific visual acuity levels.
Not a fit: Patients under 65 years old or those with other ocular or systemic conditions that could bias the assessment will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could help stabilize or improve vision in patients suffering from dry age-related macular degeneration.
How similar studies have performed: While similar approaches have been explored, this specific use of umbilical cord blood plasma for dry AMD is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rome, Rome
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome, Rome, Italy (Recruiting)
Study contacts
- Study coordinator: Maria Cristina Savastano, MD, PhD
- Email: mariacristina.savastano@policlinicogemelli.it
- Phone: 0630151
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.