Completed

A Randomized, Placebo-controlled Study Investigating the Effects of Moxaverine on Ocular Blood Flow After Oral Administration in Healthy Subjects

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What is being tested

Moxaverine

+ Placebo
Drug
Who is being recruted

Effect of Orally Administrated Moxaverine on Ocular Blood Flow

From 18 to 35 Years
+15 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Basic Science Study

Placebo-Controlled
Phase 2
Interventional
Study Start: October 2010

See protocol details

Summary

Principal SponsorMedical University of Vienna
Last updated: June 27, 2012
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2010Actual date on which the first participant was enrolled.

A number of common eye diseases such as age-related macular degeneration and glaucoma are associated with ocular perfusion abnormalities. Although this is well recognized there is not much possibility to improve blood flow to the posterior pole of the eye in these diseases. For many years, moxaverine has been used in the therapy of perfusion abnormalities in the brain, the heart and the extremities. This is based on a direct vasodilatatory effect of the drug, but also on the rheological properties of red blood cells. In two recent studies the investigators have shown that intravenous moxaverine increases choroidal and retrobulbar blood flow in healthy young subjects, in elderly people with healthy eyes and in patients with eye diseases associated with hypoperfusion. The present study aims to investigate, whether ocular blood flow is also improved after oral administration of moxaverine.

Official TitleA Randomized, Placebo-controlled Study Investigating the Effects of Moxaverine on Ocular Blood Flow After Oral Administration in Healthy Subjects 
Principal SponsorMedical University of Vienna
Last updated: June 27, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
16 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Basic Science Study
Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive different treatments one after the other, switching from one to another during the study. This helps researchers understand how individuals respond to multiple treatments.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants, researchers, and outcome assessors do not know which treatment is being given. This helps reduce bias not just during the study, but also when the results are being evaluated.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 35 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Effect of Orally Administrated Moxaverine on Ocular Blood Flow
Criteria
5 inclusion criteria required to participate
Men and women aged between 18 and 35 years, nonsmoker
Body mass index between 16 and 30 kg/m²
Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant

Show More Criteria

10 exclusion criteria prevent from participating
Regular use of medication, abuse of alcoholic beverages or drugs
Participation in a clinical trial in the 3 weeks preceding the study
Treatment in the previous 3 weeks with any drug
Symptoms of a clinically relevant illness in the 3 weeks before the first study day

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

50% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Experimental
Group II
Placebo
Study Objectives
Primary Objectives

Change in choroidal and optic nerve head blood flow after administration of moxaverine compared to placebo (measured before administration and 6 hours after administration)
Secondary Objectives

Change in retrobulbar flow velocities after administration of moxaverine compared to placebo (measured before administration and 6 hours after administration)

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Department of Clinical Pharmacology, Medical University of ViennaVienna, AustriaSee the location
CompletedOne Study Center