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Cord Blood Serum in the Treatment of Neuro-Degenerative Ophthalmic Diseases. 1-Glaucoma

Primary Purpose

Glaucoma, Neuro-Degenerative Disease

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

CBS eyedrop

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring cord blood, neuroprotection, growth factors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:
1. 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.
2. 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.

Exclusion Criteria:

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.
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

Sites / Locations

AOU Bologna, Ophthalmology Unit

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CBS eyedrop

Arm Description

The product is prepared from cord blood serum (CBS) analyzed in advance with regard to the content of specific neurotrophic growth factors.

Outcomes

Primary Outcome Measures

IOP (Intra ocular pressure)

Change of IOP at baseline, after treatment , and after two months from the end of treatment

Secondary Outcome Measures

BCVA (Best corrected visual acuity)

The change in best corrected visual acuity (BCVA) through baseline, 2 and 4 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).

Fundus ophthalmoscopy

Ophthalmoscopy of the following structures - Optic nerve - Choroid - Retina / Macula - Vitreous - Cup / Disco ratio performed by fundus oftlamoscopy

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).

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

Full Information

NCT ID

NCT03609125

First Posted

July 23, 2018

Last Updated

July 31, 2018

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Collaborators

University of Bologna

1. Study Identification

Unique Protocol Identification Number

NCT03609125

Brief Title

Cord Blood Serum in the Treatment of Neuro-Degenerative Ophthalmic Diseases. 1-Glaucoma

Official Title

Cord Blood Serum in the Treatment of Neuro-Degenerative Ophthalmic Diseases. 1-Glaucoma

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2018 (Actual)

Primary Completion Date

September 30, 2018 (Anticipated)

Study Completion Date

November 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Collaborators

University of Bologna

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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 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 10 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma, Neuro-Degenerative Disease

Keywords

cord blood, neuroprotection, growth factors

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CBS eyedrop

Arm Type

Experimental

Arm Description

The product is prepared from cord blood serum (CBS) analyzed in advance with regard to the content of specific neurotrophic growth factors.

Intervention Type

Other

Intervention Name(s)

CBS eyedrop

Intervention Description

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.

Primary Outcome Measure Information:

Title

IOP (Intra ocular pressure)

Description

Change of IOP at baseline, after treatment , and after two months from the end of treatment

Time Frame

baseline, after two months of treatment, after two months from end of treatment

Secondary Outcome Measure Information:

Title

BCVA (Best corrected visual acuity)

Description

The change in best corrected visual acuity (BCVA) through baseline, 2 and 4 months from end of treatment

Time Frame

baseline, after two months of treatment, after two months from end of treatment

Title

Visual Field

Description

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).

Time Frame

baseline, after two months of treatment, after two months from end of treatment

Title

Fundus ophthalmoscopy

Description

Ophthalmoscopy of the following structures - Optic nerve - Choroid - Retina / Macula - Vitreous - Cup / Disco ratio performed by fundus oftlamoscopy

Time Frame

baseline, after two months of treatment, after two months from end of treatment

Title

Structural measure of retinal nerve fiber layer thickness

Description

The change in retinal nerve fiber layer thickness as measured by spectral domain optical coherence tomography (sdOCT).

Time Frame

baseline, after two months of treatment, after two months from end of treatment

Title

ERG (Electroretinogram)

Description

Time Frame

baseline, after two months of treatment, after two months from end of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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. Exclusion Criteria: 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. 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emilio C CAMPOS, MD

Organizational Affiliation

AOU Policlinico S.Orsola-Malpighi and Alma Mater Studiorum University of Bologna

Official's Role

Principal Investigator

Facility Information:

Facility Name

AOU Bologna, Ophthalmology Unit

City

Bologna

ZIP/Postal Code

40138

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

data will be published in a scientific manuscript, in anonymous

Learn more about this trial

Cord Blood Serum in the Treatment of Neuro-Degenerative Ophthalmic Diseases. 1-Glaucoma

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