Status:
COMPLETED
Effects of Non-Specific Endothelin-A Receptor Blockade on Ocular Blood Flow in Patients With Glaucoma
Lead Sponsor:
Medical University of Vienna
Conditions:
Glaucoma
Blood Flow Velocity
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Several lines of evidence suggest now that ocular perfusion abnormalities may contribute to the progression of glaucoma. It has been hypothesised that increased endothelin-1 plasma levels, as seen in ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Men and women aged over 18 years
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- Inclusion criteria for patients is primary open angle glaucoma defined as pathological optic disc appearance and characteristic visual field loss
- Men and women will be included in equal parts
- Ametropia of less than 6 diopters and anisometropia of less than 2 diopters
- Exclusion Criteria (glaucoma patients)
- Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
- Smoking
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
- Elevated liver enzymes AST and ALT
- Blood donation during the previous 3 weeks
- Ametropy more than 6 dpt
- Systemic treatment with, oral antikoagulation, Glibenclamid or vasoactive drugs
- History of IOP \> 30 (untreated)
- Presence of intraocular pathology other than glaucoma
- Advanced visual field defect defined as MD \>-10
- Presence of PEX (pseudoexfoliation) glaucoma and pigment glaucoma
- Ophthalmolgical surgery (including argon laser trabeculoplasty (ALT), trabeculectomy, deep sclerectomy) within the last 6 months before the study
- Pregnancy
- Diabetes mellitus
- Exclusion criteria (healthy controls)
- Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
- Smoking
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
- Blood donation during the previous 3 weeks
- Ametropy more than 6 dpt
- Systemic treatment with oral anticoagulation, Glibenclamid or vasoactive drugs
- Elevated liver enzymes AST and ALT
- Pregnancy
- Diabetes mellitus
Exclusion
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00701597
Start Date
April 1 2007
End Date
October 1 2007
Last Update
June 19 2008
Active Locations (1)
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1
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria, A-1090