Treatment for dry age-related macular degeneration using umbilical cord blood platelet-rich plasma injections
Atrophic Age-related Macular Degeneration (AMD) Treated With Intravitreal Injections of Umbilical Cord Blood Platelet-rich Plasma (CB-PRP): a Pilot Study
This study is testing if injections of umbilical cord blood platelets can help older adults with dry age-related macular degeneration keep their vision from getting worse.
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) |
| Trial ID | NCT05706896 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the effectiveness of intravitreal injections of Umbilical Cord Blood Platelet-rich Plasma (CB-PRP) in patients with dry Age-related Macular Degeneration (AMD). The study will focus on individuals aged 65 and older who have bilateral dry AMD and specific visual acuity levels. By administering CB-PRP, the researchers hope to reduce or stabilize the progression of atrophic changes associated with this condition. The study will involve careful monitoring of visual outcomes and potential side effects following the treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 65 and older with bilateral dry AMD and specific visual acuity criteria.
Not a fit: Patients under 65 years old, those with other ocular or systemic pathologies, or those who have previously received intravitreal treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could help preserve vision and improve quality of life for patients with dry AMD.
How similar studies have performed: While the use of platelet-rich plasma in ocular conditions is emerging, this specific approach for dry AMD is novel and has not been extensively tested in prior studies.
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
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Maria Cristina savastano — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Maria Cristina Savastano
- Email: mariacristina.savastano@policlinicogemelli.it
- Phone: +390630155701
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.