Primary Open-Angle Glaucoma Primary open-angle glaucoma
Conditions
Interventions
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 t
D058492
Sponsors
Nakamura Makoto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction rate per year of mean deviation on the Humphrey visual field test (HVF) (dB/year) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactMari Sakamoto
Kobe University Hospital
Outcome results
None listed