Dry Age-related Macular DegenerationCORD-IVNCT05706896
Atrophic Age-related Macular Degeneration Treated With Intravitreal Injections of Umbilical Cord Blood Platelet-rich 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
- 14 Dec 2022to 10 Feb 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, 00168
Maria Cristina Savastano, +39 3384443002, mariacristina.savastano@unicatt.it
Maria Cristina Savastano
About this study
Official title: Atrophic Age-related Macular Degeneration (AMD) Treated With Intravitreal Injections of Umbilical Cord Blood Platelet-rich Plasma (CB-PRP): a Pilot 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)
- 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
Also called CB-PRP
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: 1 year
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
Measured: 1 year
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, months.
Measured: 1 year
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
Measured: 1 year
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
Measured: 1 year
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.
Measured: 1 year
Retinography of the ocular fundus
Change in ocular fundus
Measured: 1 year
Incomplete retinal pigment epithelial (RPE) and outer retinal atrophy (iRORA)
Change during follow ups
Measured: 1 year
Outer retinal atrophy (iRORA)
Change during follow ups
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start14 Dec 2022
- Primary completion9 Jun 2023
- Study completion10 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 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)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Cristina savastano, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706896
- Sponsor's protocol ID
- 4995
- Acronym
- CORD-IV
- Status last verified
- Sep 2025
- First submitted
- 9 Jan 2023
- Last updated
- 23 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Atrophic Age-related Macular Degeneration (AMD) Treated With Intravitreal Injections of Umbilical Cord Blood Platelet-rich Plasma (CB-PRP): a Pilot Study
- ClinicalTrials.gov ID
- NCT05706896
- Acronym / sponsor ID
- CORD-IV / 4995
- 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
- 14 Dec 2022 (actual)
- Primary completion
- 9 Jun 2023 (actual)
- Study completion
- 10 Feb 2026 (estimated)
- First posted
- 31 Jan 2023 (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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| 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-PRPAlso: 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: 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
Autofluorescence atrophy area changes in treated eyes compared with sham group (1)
Time frame: 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
7 secondary outcomes
ETDRS visual acuity
Time frame: 1 year
Mean increase in ONL thickness and retinal volumetrics
Time frame: 1 year
Mean increase in retinal volumetrics
Time frame: 1 year
Stabilization of the atrophy region of the EPR
Time frame: 1 year
Retinography of the ocular fundus
Time frame: 1 year
Incomplete retinal pigment epithelial (RPE) and outer retinal atrophy (iRORA)
Time frame: 1 year
Outer retinal atrophy (iRORA)
Time frame: 1 year
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.
- 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.
Maria Cristina savastano principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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 (+390630155701, 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: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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; AzTrials last refreshed its copy on 7 Nov 2026.