GlaucomaNCT03609125
Cord Blood Serum in the Treatment of Neuro-Degenerative Ophthalmic Diseases. 1-Glaucoma
A study testing CBS eyedrop in people with Glaucoma and Neuro-Degenerative Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
A non-randomized, monocentric clinical study with a four month follow-up period , using a cord blood serum (CBS) eye drops in glaucoma patients. The purpose of the study analyzes whether the addition of CBS to hypotonic therapy is able to slow down the progression of anatomical and functional damage induced by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Neuro-Degenerative Disease
- What is being tested?
- CBS eyedrop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2018to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all of the following criteria to join the study (all eligibility criteria must be met at the screening and baseline visits unless otherwise noted):
- Participant must be medically able to undergo the testing required in the schedule of visits
- Participant's clinical diagnosis must be consistent with glaucoma, characterized by the following features:
- Clinical evidence of progressive retinal ganglion cell (RGC) dysfunction and degeneration using both visual field and at least one structural modality as established by: i. Glaucomatous visual field abnormality. ii. Mean deviation (MD) of -3 to -15 dB. iii. Minimum average retinal nerve fiber layer (RNFL) thickness of 60 μm and maximum average RNFL of 90 μm.
- Residual visual field preservation including best-corrected visual acuity (BCVA) better than 20/200 in both eyes.
- Participant's glaucoma must be clinically stable, with intraocular pressure (IOP) < 21.
Who cannot join
- Participant has other optic nerve or retinal degenerative disease causing vision loss, irrespective of whether it is currently treated or untreated.
- Participant is blind in one eye;
- Participant has optic nerve atrophy
- Participant is receiving systemic steroids or immunosuppressive drugs, or is on chemotherapy
- Participant has a history of ocular herpes zoster.
- Participant has uveitis or other ocular inflammatory disease.
Show all 12Show fewer
- Participant has a requirement of acyclovir
- Participant has evidence of corneal opacification or lack of optical clarity.
- Participant has diabetic macular edema and/or diabetic retinopathy.
- Participant has a history of malignancy
- Participant is pregnant or lactating.
- History of use of drugs with known retinal toxicity
Trial locations and contacts
1 site in 1 country.
About this study
A non-randomized, monocentric clinical study with a four month follow-up period , using a cord blood serum (CBS) eye drops in glaucoma patients. The purpose of the study analyzes whether the addition of CBS to hypotonic therapy is able to slow down the progression of anatomical and functional damage induced by glaucoma. The study evaluates the differences after two months of treatment as compared to baseline and after two-month from the end of the treatment.
Read the detailed description
The treatment of neuroprotection of degenerative ophthalmological diseases is currently proposed by administering products belonging to the category of food supplements (nutraceuticals containing amino acids and vitamins) or compounds of vegetable origin (Curcumin, flavonoids taken with food consumption of apples and oranges, LBP Polysaccharides from goji berries etc) or specific synthesis molecules (Memantine, Citicoline, Brimonidine, Omotaurina, Polyphenols).
The rationale for the use of eye drops prepared from the blood, and in particular Cord Blood Serum (CBS), as a source is mainly based on its content in growth factors (Growth factors, GF). with particular reference in neurotrophic GFs .
Enrollment of 20 patients with glaucoma and documented progressive retinal ganglion cells (RGC) dysfunction and degeneration was performed. The product to be administered was analyzed with respect to the levels of BDNF (Brain Derived Neurotrophic Factor), beta-NGF (Neural Growth Factor) , GDNF (Glial Derived Neuronal Factor), and EGF (Epidermal Growth Factor).
Functional, electro-physiological, and structural parameters were evaluated at baseline, after two months of treatment, and after two months from the end of the treatment.
- Conditions
- Glaucoma, Neuro-Degenerative Disease
- Being tested
- CBS eyedrop
- Keywords
- cord blood, neuroprotection, growth factors
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBS eyedropOther
The product is dispensed as sterile frozen vials containing 0.8 ml of product for the daily administration. The product is thawed and administered at a dose of 1 drop / 8 times each eye during the waking period.
| Study group | Role | What they receive |
|---|---|---|
| CBS eyedrop | Experimental | The product is prepared from cord blood serum (CBS) analyzed in advance with regard to the content of specific neurotrophic growth factors. Receives: Other: CBS eyedrop |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP (Intraocular pressure)
Change of IOP at baseline, after treatment , and after two months from the end of treatment
Measured: baseline, after two months of treatment, after two months from end of treatment
Secondary outcomes (5)
BCVA (Best corrected visual acuity)
The change in best corrected visual acuity (BCVA) through baseline, 2 and 4 months from end of treatment
Measured: baseline, after two months of treatment, after two months from end of treatment
Visual Field
Evaluation of change in visual field 24-2 and 10-2, through baseline, 2 and 4 months as assessed by any one of the following two indices:
- Pattern Standard Deviation (PSD);
- Mean Deviation (MD).
Measured: baseline, after two months of treatment, after two months from end of treatment
Fundus ophthalmoscopy
Ophthalmoscopy of the following structures - Optic nerve - Choroid - Retina / Macula - Vitreous - Cup / Disco ratio performed by fundus oftlamoscopy
Measured: baseline, after two months of treatment, after two months from end of treatment
Structural measure of retinal nerve fiber layer thickness
The change in retinal nerve fiber layer thickness as measured by spectral domain optical coherence tomography (sdOCT).
Measured: baseline, after two months of treatment, after two months from end of treatment
ERG (Electroretinogram)
PERG: obtained with low temporal frequencies (maximum 4 hz equivalent to 8 inversions per second). Reversal rate: 2 hz (4 inversions / sec). Contrast: ceiling for white and black squares. Luminance: photopic. Wave width P50-N95 and wave latency P50.
Flash ERG: ERG 3.0 - maximal response in the eye adapted to the dark. Full-field stimulation with Ganzfeld's dome. Amplitude A1-B1 (the amplitude of the wave b is measured from the peak of the wave until to the peak of the wave b) - the latency of the wave b is measured by the flash lighting at the peak of the wave b
Measured: baseline, after two months of treatment, after two months from end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start1 Mar 2018
- Primary completion30 Sep 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bologna
- Responsible party
- Principal investigator, Luigi Fontana, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- Luigi FONTANA, MD, PhD, Principal investigator, AOU Policlinico S.Orsola-Malpighi and Alma Mater Studiorum University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609125
- Sponsor's protocol ID
- AOBologna
- Status last verified
- Jul 2024
- First submitted
- 23 Jul 2018
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data will be published in a scientific manuscript
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cord Blood Serum in the Treatment of Neuro-Degenerative Ophthalmic Diseases. 1-Glaucoma
- ClinicalTrials.gov ID
- NCT03609125
- Acronym / sponsor ID
- AOBologna
- Conditions
- Glaucoma, Neuro-Degenerative Disease
- Keywords
- cord blood, neuroprotection, growth factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Collaborators
- University of Bologna
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 1 Aug 2018 (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.
A non-randomized, monocentric clinical study with a four month follow-up period , using a cord blood serum (CBS) eye drops in glaucoma patients. The purpose of the study analyzes whether the addition of CBS to hypotonic therapy is able to slow down the progression of anatomical and functional damage induced by glaucoma. The study evaluates the differences after two months of treatment as compared to baseline and after two-month from the end of the treatment.
Detailed description
The treatment of neuroprotection of degenerative ophthalmological diseases is currently proposed by administering products belonging to the category of food supplements (nutraceuticals containing amino acids and vitamins) or compounds of vegetable origin (Curcumin, flavonoids taken with food consumption of apples and oranges, LBP Polysaccharides from goji berries etc) or specific synthesis molecules (Memantine, Citicoline, Brimonidine, Omotaurina, Polyphenols).
The rationale for the use of eye drops prepared from the blood, and in particular Cord Blood Serum (CBS), as a source is mainly based on its content in growth factors (Growth factors, GF). with particular reference in neurotrophic GFs .
Enrollment of 20 patients with glaucoma and documented progressive retinal ganglion cells (RGC) dysfunction and degeneration was performed. The product to be administered was analyzed with respect to the levels of BDNF (Brain Derived Neurotrophic Factor), beta-NGF (Neural Growth Factor) , GDNF (Glial Derived Neuronal Factor), and EGF (Epidermal Growth Factor).
Functional, electro-physiological, and structural parameters were evaluated at baseline, after two months of treatment, and after two months from the end of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBS eyedrop | Experimental | Other: CBS eyedropThe product is prepared from cord blood serum (CBS) analyzed in advance with regard to the content of specific neurotrophic growth factors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must meet all of the following criteria to join the study (all eligibility criteria must be met at the screening and baseline visits unless otherwise noted):
- Participant must be medically able to undergo the testing required in the schedule of visits
- Participant's clinical diagnosis must be consistent with glaucoma, characterized by the following features:
- Participant's glaucoma must be clinically stable, with intraocular pressure (IOP) < 21.
Key exclusion criteria (12 listed)
- Participant has other optic nerve or retinal degenerative disease causing vision loss, irrespective of whether it is currently treated or untreated.
- Participant is blind in one eye;
- Participant has optic nerve atrophy
- Participant is receiving systemic steroids or immunosuppressive drugs, or is on chemotherapy
- Participant has a history of ocular herpes zoster.
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 |
|---|---|---|
| CBS eyedropThe product is dispensed as sterile frozen vials containing 0.8 ml of product for the daily administration. The product is thawed and administered at a dose of 1 drop / 8 times each eye during the waking period. | Other | CBS eyedrop |
Primary outcome
IOP (Intraocular pressure)
Time frame: baseline, after two months of treatment, after two months from end of treatment
Change of IOP at baseline, after treatment , and after two months from the end of treatment
5 secondary outcomes
BCVA (Best corrected visual acuity)
Time frame: baseline, after two months of treatment, after two months from end of treatment
Visual Field
Time frame: baseline, after two months of treatment, after two months from end of treatment
Fundus ophthalmoscopy
Time frame: baseline, after two months of treatment, after two months from end of treatment
Structural measure of retinal nerve fiber layer thickness
Time frame: baseline, after two months of treatment, after two months from end of treatment
ERG (Electroretinogram)
Time frame: baseline, after two months of treatment, after two months from end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Individual participant dataSharing planned: No. data will be published in a scientific manuscript
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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. This study is not recruiting at the moment.
Luigi FONTANA, MD, PhD principal investigator
AOU Policlinico S.Orsola-Malpighi and Alma Mater Studiorum University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBS eyedrop in people with Glaucoma and Neuro-Degenerative Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 6 inclusion and 12 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: finished, as of the sponsor's last update on 19 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOP (Intraocular pressure) (time frame: baseline, after two months of treatment, after two months from end of treatment). 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 19 Jul 2024.