Atrophic Age-related Macular Degeneration (AMD) Treated With Intravitreal Injections of Umbilical Cord Blood Platelet-rich Plasma (CB-PRP): a Pilot Study

Dry Age-related Macular Degeneration Clinical Trial

— CORD-IV  

Official title:

Atrophic Age-related Macular Degeneration (AMD) Treated With Intravitreal Injections of Umbilical Cord Blood Platelet-rich Plasma (CB-PRP): a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05706896
• Other study ID #: 4995
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2022
• Est. completion date: June 10, 2025

Study information

• Verified date: December 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: June 10, 2025
• Est. primary completion date: June 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Age-related Macular Degeneration
• Macular Degeneration

Intervention

Procedure:
• Intravitreal injection of CB-PRP
The procedure consists in a trans-scleral puncture to access the vitreous cavity, with subsequent injection of CB-PRP

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluation of therapy safety	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.	1 year
Primary	Autofluorescence atrophy area changes in treated eyes compared with sham group	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	1 year
Primary	Autofluorescence atrophy area changes in treated eyes compared with sham group (1)	Stabilization of the enlargement of the hyperfluorescent area (atrophy enhancement) or at most a maximum increase of not more than 20% from the baseline	1 year
Secondary	ETDRS visual acuity	Increase of at least two lines from baseline measurement and/or to the contralateral untreated eye at 3 and 6, 12, months.	1 year
Secondary	Mean increase in ONL thickness and retinal volumetrics	Mean increase, measured by high-resolution quantitative OCT, of at least 20% from baseline at 3 and 6, 12, months	1 year
Secondary	Mean increase in retinal volumetrics	Mean increase, measured by high-resolution quantitative OCT, of at least 20% from baseline at 3 and 6, 12, months	1 year
Secondary	Stabilization of the atrophy region of the EPR	Stabilization in enface OCT with less than 20% increase from baseline, comparing it with the placebo group, at 3 and 6, 12, months.	1 year
Secondary	Retinography of the ocular fundus	Change in ocular fundus	1 year
Secondary	Incomplete retinal pigment epithelial (RPE) and outer retinal atrophy (iRORA)	Change during follow ups	1 year
Secondary	Outer retinal atrophy (iRORA)	Change during follow ups	1 year