Cord Blood Serum in the Treatment of Neuro-Degenerative Ophthalmic Diseases. 1-Glaucoma (NCT03609125) | Clinical Trial Compass
CompletedNot Applicable
Cord Blood Serum in the Treatment of Neuro-Degenerative Ophthalmic Diseases. 1-Glaucoma
Italy20 participantsStarted 2018-03-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
What they're measuring
1
IOP (Intraocular pressure)
Timeframe: baseline, after two months of treatment, after two months from end of treatment
Trial details
NCT IDNCT03609125
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna