臨床研究等提出・公開システム

An exploratory single-arm, open-label, interventional study to evaluate the inhibitory effect of metformin in non-diabetic patients with primary open-angle glaucoma on the progression of visual field damage.

A multi-institutional study to investigate the neuroprotective effects of metformin in patients with POAG.

Nakamura Makoto

Kobe University Hospital

7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo

manakamu@med.kobe-u.ac.jp

Sakamoto Mari

Kobe University Hospital

7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo

+81-78-382-6048

mariwsakamoto@people.kobe-u.ac.jp

Recruiting

Oct. 11, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. Primary open-angle glaucoma patients aged between 20 and 73
2. Both sex
3. Best corrected visual acuity of 0.5 or more in a targeted eye
4. Mean deviation (MD) of the Humphrey visual field test program 24-2 or 30-2 ranging from -3.0 and -15.0dB in a targeted eye
5. MD progression speed between -0.3 and -1.0dB/year calucluaetd from at least 6 test times during the latest 2 tot 3 years
6. Reliable indices (fixatio loss, false negative, false positive) in all of the HVF test results collected as in the item 5 should all be less than 33%
7. Intraocular pressure under tolerable anti-glaucoma eye drop medication use in the target eye should be consistently between 5 and 15 mmHg during the entire period to collected the HVF test results as in the item 5.
8. Written infromed consent with a volantary will should be obtained from the patient.

1. Treated or suspected diabetes mellius (HbA1C over 6.2 percent)
2. Under dimentia treatment
3. Eyes with any intraocular surgery (glaucoma surgery, laser treatment, cataract surgery, vitrectomy) within the latest 3 years (or within the latest 2 years if the eye underwetn at least 6 HVF tests within the latest 2 yeras)
4. Eyes with corneal, media, or fundus pathologies other than POAG (including myopic retinochoroidal atrophy), whihc may affect the HVF test results
5. Currently or scheduled continous (over 3 months) corticosteroid use (oral, nasal, eyelid oitment, or betamethasone or dexamethasone eye drop).
6. Systemic illness that may affect the HVF test results (brain stroke, brain tumor, multiple sclerosis, neuromyelitis optica, etc)
7. Eye doncitions that preclude accurate intraocular pressure measurement (post-keraoplasty, post-refractive surgery, etc)
8. Current anti-glaucoma eye drop regimen is likely to be changed or intraocular surgery is likely to be performed by the next 2 years
9. Moderate or severe renal dysfunction (eGFR<45mL/min/1.73m2)
10. Moderate or severe liver dysfunction (AST equal to or more than 100U/L, ALT equal to or more than 112.5U/L, gamma-GTP equal to or more than 200(men)U/L and 120(women)U/L)
11. Na <135mEq/L or equal to or more than 217mEq/L
12. Past or present history of mycaridal infarction, heart failure (NT-proBNP equal to or more than 400), respiratory dysfunction (including chronic obstructive pulmonray disorder)
13. Patients who undergo tests and treatments using contrast media (e.g., coronary artery treatment and follow-up examinations, contrast CT scans) at least twice a year.
14. Patients scheduled any surgery that reqiued drinking restriction over 1 month during the protocol treament period.
15. Oral diuretic, SGLT2 inhibitor, or carbonic anhydrase inhibitor users
16. Hypersesitive or idiosyncratic trait such as allergic to drugs
17. Pregnant, expected pregnant,or breastfeeding women
18. Patients with any conditions that are contraindicative for the protocol medication, which are described in Package Inserts (history of lactic acidosis, severe, ketoacidosis, or diabetic come or pre-coma, or malnutrition, starvation, breakdown, pituitary dysfunction or adrenal insufficiency, etc)
19. Patients who are under treatment of polycystic ovary syndrome
20. Patients who have a lower bowel disease (Crohn's disease, ulcerative collitis, short bowel syndrome, celiac disease, a history of intestinal resection, etc)
21. Patients who participated in other clinical trials within 4 months
22. Patients deemed inappropriate by the investigators in charge of this clinical study

Both

Primary Open-Angle Glaucoma

Primary open-angle glaucoma patients who meet enrollment criteria will receive perorally one 250mg tablet of metoformin hydrochloride twice daily for initial 4 weeks (500mg/day intotal), two tablets twice daily (1000mg/day in total) for next 4 weeks (5~8 weeks), and three tablets twice daily (1500mg/day in total) for subsequent 4 weeks (9~12 weeks). If tolerable without side effect, they will receive three tablets twice daily (1500mg/day) thereafter until the end of 96 weeks.

Primary open-angle glaucoma

D005902

D058492

Reduction rate per year of mean deviation on the Humphrey visual field test (HVF) (dB/year)

1. Progression event judged by Guided Progression Analysis or Food and Drug Administration criteria
2. Presence or absence of adverse events which are presumed to be relevant to this study

+81-78-382-6669

Aug. 07, 2024

none