Dry Age-related Macular DegenerationM-CORD IVNCT06536062
Age-related Macular Degeneration of Atrophic Type Treated With Umbilical Cord Blood Enriched With Platelet Plasma.
A study testing Intravitreal injection of CB-PRP in people with Dry Age-related Macular Degeneration, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dry Age-related Macular Degeneration
- What is being tested?
- Intravitreal injection of CB-PRP
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jul 2024to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Rome, 00168
Maria Cristina Savastano, +39 3384443002, mariacristina.savastano@unicatt.it
Maria Cristina Savastano
About this study
Official title: Age-related Macular Degeneration of Atrophic Type Treated With Intravitreal Injection of Umbilical Cord Blood Enriched With Platelet Plasma: Multicenter Study.
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).
Read the detailed description
Patients will undergo intravitreal injections of CB-PRP (Cord Blood Platelet-rich Plasma) according to three different treatment regimens, and the efficacy and safety of CB-PRP in an in vitro model of lipopolysaccharide (LPS)-induced degeneration in hTERT RPE-1 and ARPE-19 model cell lines derived from retinal pigmented epithelium (RPE) will be evaluated.
The purpose of this study is to evaluate the safety and efficacy of different temporal regimens of intravitreal administration of CB-PRP and the response of photoreceptors in the macular region in dry-AMD. Microanatomical changes in the retina induced by intravitreal CB-PRP therapy and measured by advanced retinal imaging techniques will be evaluated as an important signal of efficacy.
- Conditions
- Dry Age-related Macular Degeneration
- Being tested
- Intravitreal injection of CB-PRP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal injection of CB-PRPProcedure or surgery
The procedure consists in a trans-scleral puncture to access the vitreous cavity, with subsequent injection of CB-PRP
| Study group | Role | What they receive |
|---|---|---|
| Monthly injection | Experimental | The patients will recive 12 intravitreal injections in one eye and 12 sham injections in the other eye each month Receives: Procedure: Intravitreal injection of CB-PRP |
| Bimonthly injection | Experimental | The patients will receive 6 intravitreal injections in one eye and 6 sham injections in the other eye each two months Receives: Procedure: Intravitreal injection of CB-PRP |
| Quarterly injection | Experimental | The patients will receive 4 intravitreal injections in one eye and 4 sham injections in the other eye each three months Receives: Procedure: Intravitreal injection of CB-PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (7)
ETDRS visual acuity
Increase of at least two lines from baseline measurement and/or to the contralateral untreated eye at 3 and 6, 12,24 months.
Measured: 24 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, 24 months
Measured: 24 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, 24 months
Measured: 24 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, 12,24 months.
Measured: 24 months
Retinography of the ocular fundus
Change in ocular fundus
Measured: 24 months
Incomplete retinal pigment epithelial (RPE) and outer retinal atrophy (iRORA)
Change during follow ups
Measured: 24 months
Outer retinal atrophy (iRORA)
Change during follow ups
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start20 Jul 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dry Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Savastano Maria Cristina, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536062
- Sponsor's protocol ID
- 6848
- Acronym
- M-CORD IV
- Status last verified
- Sep 2025
- First submitted
- 19 Jul 2024
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heier JS, Pieramici D, Chakravarthy U, Patel SS, Gupta S, Lotery A, Lad EM, Silverman D, Henry EC, Anderesi M, Tschosik EA, Gray S, Ferrara D, Guymer R; Chroma and Spectri Study Investigators. Visual Function Decline Resulting from Geographic Atrophy: Results from the Chroma and Spectri Phase 3 Trials. Ophthalmol Retina. 2020 Jul;4(7):673-688. doi: 10.1016/j.oret.2020.01.019. Epub 2020 Jan 31.
PubMed 32199866Pfau M, Kunzel SH, Pfau K, Schmitz-Valckenberg S, Fleckenstein M, Holz FG. Multimodal imaging and deep learning in geographic atrophy secondary to age-related macular degeneration. Acta Ophthalmol. 2023 Dec;101(8):881-890. doi: 10.1111/aos.15796.
PubMed 37933610
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-related Macular Degeneration of Atrophic Type Treated With Intravitreal Injection of Umbilical Cord Blood Enriched With Platelet Plasma: Multicenter Study.
- ClinicalTrials.gov ID
- NCT06536062
- Acronym / sponsor ID
- M-CORD IV / 6848
- Conditions
- Dry Age-related Macular Degeneration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 20 Jul 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Patients will undergo intravitreal injections of CB-PRP (Cord Blood Platelet-rich Plasma) according to three different treatment regimens, and the efficacy and safety of CB-PRP in an in vitro model of lipopolysaccharide (LPS)-induced degeneration in hTERT RPE-1 and ARPE-19 model cell lines derived from retinal pigmented epithelium (RPE) will be evaluated.
The purpose of this study is to evaluate the safety and efficacy of different temporal regimens of intravitreal administration of CB-PRP and the response of photoreceptors in the macular region in dry-AMD. Microanatomical changes in the retina induced by intravitreal CB-PRP therapy and measured by advanced retinal imaging techniques will be evaluated as an important signal of efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Monthly injection | Experimental | Procedure: Intravitreal injection of CB-PRPThe patients will recive 12 intravitreal injections in one eye and 12 sham injections in the other eye each month |
| Bimonthly injection | Experimental | Procedure: Intravitreal injection of CB-PRPThe patients will receive 6 intravitreal injections in one eye and 6 sham injections in the other eye each two months |
| Quarterly injection | Experimental | Procedure: Intravitreal injection of CB-PRPThe patients will receive 4 intravitreal injections in one eye and 4 sham injections in the other eye each three months |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravitreal injection of CB-PRPThe procedure consists in a trans-scleral puncture to access the vitreous cavity, with subsequent injection of CB-PRP | Procedure or surgery | Bimonthly injection, Monthly injection, Quarterly injection |
Primary outcome
Autofluorescence atrophy area changes in treated eyes compared with sham group
Time frame: 24 months
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
7 secondary outcomes
ETDRS visual acuity
Time frame: 24 months
Mean increase in ONL thickness and retinal volumetrics
Time frame: 24 months
Mean increase in retinal volumetrics
Time frame: 24 months
Stabilization of the atrophy region of the EPR
Time frame: 24 months
Retinography of the ocular fundus
Time frame: 24 months
Incomplete retinal pigment epithelial (RPE) and outer retinal atrophy (iRORA)
Time frame: 24 months
Outer retinal atrophy (iRORA)
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Background: PubMed 32199866Heier JS, Pieramici D, Chakravarthy U, Patel SS, Gupta S, Lotery A, Lad EM, Silverman D, Henry EC, Anderesi M, Tschosik EA, Gray S, Ferrara D, Guymer R; Chroma and Spectri Study Investigators. Visual Function Decline Resulting from Geographic Atrophy: Results from the Chroma and Spectri Phase 3 Trials. Ophthalmol Retina. 2020 Jul;4(7):673-688. doi: 10.1016/j.oret.2020.01.019. Epub 2020 Jan 31.
- Background: PubMed 37933610Pfau M, Kunzel SH, Pfau K, Schmitz-Valckenberg S, Fleckenstein M, Holz FG. Multimodal imaging and deep learning in geographic atrophy secondary to age-related macular degeneration. Acta Ophthalmol. 2023 Dec;101(8):881-890. doi: 10.1111/aos.15796.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravitreal injection of CB-PRP in people with Dry Age-related Macular Degeneration, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Cristina Savastano, MD, PhD (0630151, mariacristina.savastano@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autofluorescence atrophy area changes in treated eyes compared with sham group (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06536062, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.