Arterial hypertension and glaucoma
Conditions
Interventions
Product Name: Nebivolol
Pharmaceutical Form: Tablet
INN or Proposed INN: Nebivolol
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Product Name: Concor
Pharmace
Sponsors
Berlin-Chemie Menarini
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 years or older 2. Stable glaucoma associated with a pathological excavation of the optical nerve head and visual field defects 3. No other previous eye surgery than cataract surgery and/or cyclophotocoagulation, deep sclerectomy, trabeculectomy or related surgical procedures which were performed > 4 weeks before study entry 4. Refractive error between – 6 and + 6 dpt 5. Arterial hypertension adequately and stable (= 3 months) treated in combination- or mono therapy with a beta-blocker except for current treatment with Nebivolol, Bisoprolol or Carvidilol (blood pressure prior to switch of the antihypertensive medication to the trial medication: =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Secondary hypertension 2. Untreated heart failure or uncompensated heart failure 3. Sick-sinus-syndrome including heart blocks (SA node) and/or AV block 2nd and 3rd degree and/or significant arrhythmia and/or bradycardia 1.75 mg/dl (> 30 µ mol/l) or clinical evidence of severe hepatic disease or hepatic failure 10. Untreated pheochromocytoma 11. Metabolic acidosis 12. Peripheral arterial occlusive disease > IIa (PAOD) or Raynaud’s syndrome 13. History of myocardial infarction within the last 3 months prior to study inclusion 14. Unstable angina pectoris 15. Prior or active malignancy in the previous 5 years except adequately treated basal cell/ squamous cell carcinoma of the skin or carcinoma in situ of the cervix 16. Previous treatment within 30 days prior to the beginning of the study or concomitant treatment with substances which may decrease the efficacy of the test substance(s) or may lead to drug interactions, for example: MAO inhibitors, systemic sympathomi- metics, intravenous application of calcium-antagonists of verapamil- or diltiazem-type or other antiarrhythmic agents except for intensive care, aldosterone analogues 17. Anticipated dose change of statins if patient is treated with statins already or anticipated need for statins if patient is currently not treated with statins 18. Previous topical and/or systemic glaucoma medication not stable for > 14 days prior to visit 2 19. Anticipated dose change of topical glaucoma medication (including dorzolamide) or anticipated dose change of magnesium-containing preparations 20. Patients with psychiatric diseases 21. Patients with a history of alcohol and/or drug abuse 22. Patients who are currently participating in another clinical study or who have received an investigational drug within 30 days prior to entering the study 23. Patients who are unwilling or unable to provide informed consent or to participate satisfactorily for the entire trial period 24. Women of childbearing potential without adequate contraception; medically acceptable methods are contraceptive implant (contraceptive injection, intrauterine device (IUD), or oral contraceptives taken for at least 3 months, which the patient agrees to continue using during the study. 25. Patients who are pregnant or lactate (Pregnancy should be ruled out by serum pregnancy test) 26. Intake of coffee and/or smoking < 2 hours before Laser Doppler Flowmetry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the influence of Nebivolol as compared to Bisoprolol on the peak systolic and end-diastolic blood flow velocity in the short and the long posterior ciliary artery. It is assumed that Nebivolol may influence the ocular perfusion positively by peripheral vasodilatation induced by the stimulation of the NO-system. ;Secondary Objective: To assess the influence of Nebivolol as compared to Bisoprolol - on the peak systolic and end-diastolic blood flow velocity in the central retinal artery - on the peak systolic and end-diastolic blood flow velocity in the ophthalmic artery - on the resistive index (RI) in the: a.short posterior ciliary artery b.long posterior ciliary artery c.central retinal artery d.ophthalmic artery - on the pulsatility index (PI) in the a.short posterior ciliary artery b.long posterior ciliary artery c.central retinal artery d.ophthalmic artery - on capillary blood flow in the retina - on the diameter of retinal vessels - on the Time average maximum velocity (TAMx) - on the Time average minimum velocity (TAMm) - on the blood pressure ;Primary end point(s): Primary efficacy variable: - Peak systolic blood flow velocity (PSV) in the short posterior ciliary artery - PSV in the long posterior ciliary artery - End diastolic blood flow velocity (EDV) in the short posterior ciliary artery - EDV in the long posterior ciliary artery Secondary efficacy variable(s): - Changes of the peak systolic and end systolic blood flow velocity in the central retinal artery after 6 weeks of treatment - Changes of the peak systolic and end systolic blood flow velocity in the ophthalmic artery after 6 weeks of treatment - Changes of the resistive index (RI) after 6 weeks of treatment in - short posterior ciliary artery - long posterior ciliary artery - central retinal artery - ophthalmic artery - Changes of the pulsatility index (PI) after 6 weeks of treatment in - short posterior ciliary artery - long posterior ciliary artery | — |
Countries
Germany
Outcome results
None listed