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

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Recruiting
CT.gov ID
NCT05706896
Collaborator
(none)
36
Enrollment
1
Location
3
Arms
5.8
Anticipated Duration (Months)
6.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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)

Condition or Disease Intervention/Treatment Phase
  • Procedure: Intravitreal injection of CB-PRP
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomization will take place by eye, each patient will have one eye treated and the contralateral subjected to sham. The treated eye will receive CB-PRP injections modulated differently over time in each of the sub-studies, i.e. monthly, bimonthly or quarterly, while the contralateral eye will receive a SHAM injection.Randomization will take place by eye, each patient will have one eye treated and the contralateral subjected to sham. The treated eye will receive CB-PRP injections modulated differently over time in each of the sub-studies, i.e. monthly, bimonthly or quarterly, while the contralateral eye will receive a SHAM injection.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Atrophic Age-related Macular Degeneration (AMD) Treated With Intravitreal Injections of Umbilical Cord Blood Platelet-rich Plasma (CB-PRP): a Pilot Study
Actual Study Start Date :
Dec 14, 2022
Anticipated Primary Completion Date :
Jun 9, 2023
Anticipated Study Completion Date :
Jun 10, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Monthly injection

The patients will recive 12 intravitreal injections in one eye and 12 sham injections in the other eye each month

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
Other Names:
  • CB-PRP

    		•
    Experimental: Bimonthly injection

    The patients will receive 6 intravitreal injections in one eye and 6 sham injections in the other eye each two months

    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
    Other Names:
  • CB-PRP

    		•
    Experimental: Quarterly injection

    The patients will receive 4 intravitreal injections in one eye and 4 sham injections in the other eye each three months

    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
    Other Names:
  • CB-PRP

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Autofluorescence atrophy area changes in treated eyes compared with sham group [1 year]

      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

    2. Autofluorescence atrophy area changes in treated eyes compared with sham group (1) [1 year]

      Stabilization of the enlargement of the hyperfluorescent area (atrophy enhancement) or at most a maximum increase of not more than 20% from the baseline

    Secondary Outcome Measures

    1. ETDRS visual acuity [1 year]

      Increase of at least two lines from baseline measurement and/or to the contralateral untreated eye at 3 and 6, 12, months.

    2. Mean increase in ONL thickness and retinal volumetrics [1 year]

      Mean increase, measured by high-resolution quantitative OCT, of at least 20% from baseline at 3 and 6, 12, months

    3. Mean increase in retinal volumetrics [1 year]

      Mean increase, measured by high-resolution quantitative OCT, of at least 20% from baseline at 3 and 6, 12, months

    4. Stabilization of the atrophy region of the EPR [1 year]

      Stabilization in enface OCT with less than 20% increase from baseline, comparing it with the placebo group, at 3 and 6, 12, months.

    5. Retinography of the ocular fundus [1 year]

      Change in ocular fundus

    6. Incomplete retinal pigment epithelial (RPE) and outer retinal atrophy (iRORA) [1 year]

      Change during follow ups

    7. Outer retinal atrophy (iRORA) [1 year]

      Change during follow ups

    Other Outcome Measures

    1. Evaluation of therapy safety [1 year]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy 00168

    Sponsors and Collaborators

    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    ClinicalTrials.gov Identifier:
    NCT05706896
    Other Study ID Numbers:
    • 4995
    First Posted:
    Jan 31, 2023
    Last Update Posted:
    Jan 31, 2023
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Macular Degeneration

    Study Results

    No Results Posted as of Jan 31, 2023