Visual Function Decline Resulting from Geographic Atrophy: Results from the Chroma and Spectri Phase 3 Trials.
Jeffrey S Heier, Dante Pieramici, Usha Chakravarthy...
https://pubmed.ncbi.nlm.nih.gov/32199866Actively Recruiting
Phase Not Applicable
Age: 65Years +
All Genders
ID06536062
Age-related Macular Degeneration of Atrophic Type Treated With Intravitreal Injection of Umbilical Cord Blood Enriched With Platelet Plasma: Multicenter Study.
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-09-23
36
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of intravitreal injections of Umbilical Cord Blood Platelet-rich Plasma (CB-PRP) for slowing or stabilizing the atrophic progression in people with dry Age-related Macular Degeneration (AMD). This study aims to assess the safety and impact of different treatment schedules of CB-PRP on the retina, specifically focusing on photoreceptor responses in the macular area. Advanced retinal imaging will be used to monitor microanatomical changes as key indicators of treatment efficacy. Participants will receive one of three treatment regimens involving intravitreal injections of CB-PRP in one eye and sham injections in the other. The regimens include 12 monthly injections, 6 injections every two months, or 4 injections every three months. The procedure involves a trans-scleral puncture to deliver CB-PRP directly into the vitreous cavity. The study is randomized with single masking to compare the outcomes between treated and sham-injected eyes. During the 24-month study, participants will undergo regular assessments including retinal imaging and visual acuity tests. Researchers will measure changes in the area of atrophy using autofluorescence, retinal thickness, volumetrics, and signs of retinal pigment epithelial and outer retinal atrophy. Safety and treatment adherence will also be monitored throughout the study period to evaluate the long-term effects of CB-PRP injections.
CONDITIONS
Brief Title
Age-related Macular Degeneration of Atrophic Type Treated With Umbilical Cord Blood Enriched With Platelet Plasma.
Who Can Participate
Age: 65Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 65 years
- Bilateral dry Age-related Macular Degeneration
- 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
You will not qualify if you...
- Age < 65 years
- Pregnancy
- Previous inflammatory or infectious events involving the eyes
- Eye trauma, diabetes, or disease potentially damaging to the visual system, even if no impairment is present at intake
- Previous intravitreal treatments
- Refusal to sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 24 months
Participants receive intravitreal injections of CB-PRP or sham injections in one or both eyes according to their assigned regimen to evaluate safety and efficacy in treating dry Age-related Macular Degeneration.
12, 6, or 4 injection visits depending on monthly, bimonthly, or quarterly regimen
Follow-up
Duration - Up to 24 months
Participants are monitored for treatment effects and retinal changes using imaging and visual acuity assessments.
Periodic visits for assessments during and after treatment up to 24 months
Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Rome, Italy, 00168
Actively Recruiting
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Research Team
M
Maria Cristina Savastano, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Multimodal imaging and deep learning in geographic atrophy secondary to age-related macular degeneration.
Maximilian Pfau, Sandrine H Künzel, Kristina Pfau...
https://pubmed.ncbi.nlm.nih.gov/37933610