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

NCT03609125 | Completed

• 1 other identifier: AOBologna
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma; Neuro-Degenerative Disease

Keywords

cord blood; neuroprotection; growth factors

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• BCVA (Best corrected visual acuity)

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

• Visual Field

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

• Fundus ophthalmoscopy

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

• Structural measure of retinal nerve fiber layer thickness

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

• ERG (Electroretinogram)

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

Study Arms (1)

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.

Other: CBS eyedrop

Interventions

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.

CBS eyedrop

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead
• University of Bologna: collaborator

Study Sites (1)

IRCCS AOUBO, Ophthalmology Unit

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Luigi FONTANA, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Ophthalmology - University of Bologna

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: August 1, 2018
• Study Start: March 1, 2018
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)