Back to resultsAtrophic Age-related Macular Degeneration (AMD) Treated With Intravitreal Injections of Umbilical Cord Blood Platelet-rich Plasma (CB-PRP): a Pilot Study (CORD-IV)
Primary Purpose
Dry Age-related Macular Degeneration
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Intravitreal injection of CB-PRP
Sponsored by
About this trial
This is an interventional treatment trial for Dry Age-related Macular Degeneration
Eligibility 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.
Sites / Locations
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Monthly injection
Bimonthly injection
Quarterly injection
Arm Description
The patients will recive 12 intravitreal injections in one eye and 12 sham injections in the other eye each month
The patients will receive 6 intravitreal injections in one eye and 6 sham injections in the other eye each two months
The patients will receive 4 intravitreal injections in one eye and 4 sham injections in the other eye each three months
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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.
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
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
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.
Retinography of the ocular fundus
Change in ocular fundus
Incomplete retinal pigment epithelial (RPE) and outer retinal atrophy (iRORA)
Change during follow ups
Outer retinal atrophy (iRORA)
Change during follow ups
Full Information
NCT ID
NCT05706896
First Posted
January 9, 2023
Last Updated
January 23, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1. Study Identification
Unique Protocol Identification Number
NCT05706896
Brief Title
Atrophic Age-related Macular Degeneration (AMD) Treated With Intravitreal Injections of Umbilical Cord Blood Platelet-rich Plasma (CB-PRP): a Pilot Study
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2022 (Actual)
Primary Completion Date
June 9, 2023 (Anticipated)
Study Completion Date
June 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Age-related Macular Degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Monthly injection
Arm Type
Experimental
Arm Description
The patients will recive 12 intravitreal injections in one eye and 12 sham injections in the other eye each month
Arm Title
Bimonthly injection
Arm Type
Experimental
Arm Description
The patients will receive 6 intravitreal injections in one eye and 6 sham injections in the other eye each two months
Arm Title
Quarterly injection
Arm Type
Experimental
Arm Description
The patients will receive 4 intravitreal injections in one eye and 4 sham injections in the other eye each three months
Intervention Type
Procedure
Intervention Name(s)
Intravitreal injection of CB-PRP
Other Intervention Name(s)
CB-PRP
Intervention Description
The procedure consists in a trans-scleral puncture to access the vitreous cavity, with subsequent injection of CB-PRP
Primary Outcome Measure Information:
Title
Autofluorescence atrophy area changes in treated eyes compared with sham group
Description
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
Time Frame
1 year
Title
Autofluorescence atrophy area changes in treated eyes compared with sham group (1)
Description
Stabilization of the enlargement of the hyperfluorescent area (atrophy enhancement) or at most a maximum increase of not more than 20% from the baseline
Time Frame
1 year
Secondary Outcome Measure Information:
Title
ETDRS visual acuity
Description
Increase of at least two lines from baseline measurement and/or to the contralateral untreated eye at 3 and 6, 12, months.
Time Frame
1 year
Title
Mean increase in ONL thickness and retinal volumetrics
Description
Mean increase, measured by high-resolution quantitative OCT, of at least 20% from baseline at 3 and 6, 12, months
Time Frame
1 year
Title
Mean increase in retinal volumetrics
Description
Mean increase, measured by high-resolution quantitative OCT, of at least 20% from baseline at 3 and 6, 12, months
Time Frame
1 year
Title
Stabilization of the atrophy region of the EPR
Description
Stabilization in enface OCT with less than 20% increase from baseline, comparing it with the placebo group, at 3 and 6, 12, months.
Time Frame
1 year
Title
Retinography of the ocular fundus
Description
Change in ocular fundus
Time Frame
1 year
Title
Incomplete retinal pigment epithelial (RPE) and outer retinal atrophy (iRORA)
Description
Change during follow ups
Time Frame
1 year
Title
Outer retinal atrophy (iRORA)
Description
Change during follow ups
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Evaluation of therapy safety
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
City
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Cristina Savastano
Phone
+39 3384443002
Email
mariacristina.savastano@unicatt.it
First Name & Middle Initial & Last Name & Degree
Maria Cristina Savastano
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Atrophic Age-related Macular Degeneration (AMD) Treated With Intravitreal Injections of Umbilical Cord Blood Platelet-rich Plasma (CB-PRP): a Pilot Study
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