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Effects of Non-Specific Endothelin-A Receptor Blockade on Ocular Blood Flow in Patients With Glaucoma

Primary Purpose

Glaucoma, Blood Flow Velocity

Status

Completed

Phase

Phase 1

Locations

Austria

Study Type

Interventional

Intervention

bosentan

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring ocular blood flow dysregulation, glaucoma, endothelin-1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Department of Clinical Pharmacology, Medical University of Vienna

Outcomes

Primary Outcome Measures

Optic nerve head blood flow (Laser Doppler Flowmetry) Choroidal blood flow(Laser interferometry, Laser Doppler Flowmetry) Retinal blood flow(Laser Doppler velocimetry, Retinal Vessel analyzer) Intraocular pressure (Applanation tonometry)

Secondary Outcome Measures

Full Information

NCT ID

NCT00701597

First Posted

June 18, 2008

Last Updated

June 18, 2008

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT00701597

Brief Title

Effects of Non-Specific Endothelin-A Receptor Blockade on Ocular Blood Flow in Patients With Glaucoma

Official Title

Effects of Non-Specific Endothelin-A Receptor Blockade on Ocular Blood Flow in Patients With Glaucoma.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2008

Overall Recruitment Status

Completed

Study Start Date

April 2007 (undefined)

Primary Completion Date

September 2007 (Actual)

Study Completion Date

October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Medical University of Vienna

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 patients with glaucoma, may be related to these alterations in ocular blood flow. We could show in recent experiments that administration of ET-1 decreases ocular blood flow, whereas blocking of the ET-A receptors do not affect basal vascular tone in healthy subjects. In the current study we set out to evaluate the effect Bosentan, a non-selective ETA-receptor antagonist in patients with open-angle glaucoma. This should allow us to test the hypothesis that administration of an ET-1 receptor antagonist increases ocular blood flow in patients with glaucoma. Investigations will be done with a retinal vessel analyzer to determine retinal vessel cross-sectional diameters, with laser Doppler flowmetry and laser Doppler velocimetry to determine subfoveal macular blood flow and optic nerve head blood flow and with laser interferometric measurements to determine fundus pulsation amplitude in the macula. The intraocular pressure will be measured with applanation tonometry. This will be assessed at baseline and in response to peroral application of Bosentan or placebo. The study objective is therefor, to evaluate the contribution of ET-1 to ocular blood flow dysregulation in patients with open-angle glaucoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma, Blood Flow Velocity

Keywords

ocular blood flow dysregulation, glaucoma, endothelin-1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

bosentan

Intervention Description

Bosentan (Tracleer 125mg Tabletts), peroral, dose: 500mg for 8 days

Primary Outcome Measure Information:

Title

Time Frame

study 1: ocular blood flow measurements once; study day 2: basline measurements, and after 120min, 180min, 240min after medication intake

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gabriele Fuchsjager-Mayrl, MD

Organizational Affiliation

Department of Clinical Pharmacology, Medical University of Vienna

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Clinical Pharmacology, Medical University of Vienna

City

Vienna

ZIP/Postal Code

A-1090

Country

Austria

12. IPD Sharing Statement

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Effects of Non-Specific Endothelin-A Receptor Blockade on Ocular Blood Flow in Patients With Glaucoma

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