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| Name | Class |
|---|---|
| University of Bologna | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBS eyedrop | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| IOP (Intraocular pressure) | Change of IOP at baseline, after treatment , and after two months from the end of treatment | baseline, after two months of treatment, after two months from end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| BCVA (Best corrected visual acuity) | The change in best corrected visual acuity (BCVA) through baseline, 2 and 4 months from end of treatment | baseline, after two months of treatment, after two months from end of treatment |
| Visual Field |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luigi FONTANA, MD, PhD | AOU Policlinico S.Orsola-Malpighi and Alma Mater Studiorum University of Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS AOUBO, Ophthalmology Unit | Bologna | 40138 | Italy |
data will be published in a scientific manuscript
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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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:
| 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 | 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). | 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 | baseline, after two months of treatment, after two months from end of treatment |