NCT03609125Completed
Cord Blood Serum in the Treatment of Neuro-Degenerative Ophthalmic Diseases. 1-Glaucoma
Source: ClinicalTrials.gov · Last updated 19 Jul 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 23 Jul 2018
- Start date
- 1 Mar 2018
- Primary completion date
- 30 Sept 2023
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Diseases
- Glaucoma
- NCT number
- NCT03609125
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 1 Mar 2018 to the primary completion date, 30 Sept 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participant is receiving systemic steroids or immunosuppressive drugs, or is on chemotherapy
Other illness
- Participant has other optic nerve or retinal degenerative disease causing vision loss, irrespective of whether it is currently treated or untreated.
- Participant has a history of ocular herpes zoster.
- Participant has uveitis or other ocular inflammatory disease.
- Participant has a history of malignancy
- History of use of drugs with known retinal toxicity
Other
- Participant is blind in one eye;
- Participant has optic nerve atrophy
- 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 is pregnant or lactating.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS AOUBO, Ophthalmology Unit Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.