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Could a blood vessel drug reverse sudden blindness in giant cell arteritis?

NCT ID NCT03841734

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This trial investigates whether bosentan, a drug that blocks endothelin and relaxes blood vessels, can help people who suddenly lose vision from giant cell arteritis (Horton's disease). Standard steroid treatment often fails to restore sight once blindness occurs. The study enrolls 8 adults with recent vision loss and gives them bosentan for 14 days alongside usual care. Researchers measure changes in visual acuity and visual fields to see if early treatment can limit permanent damage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Bosentan
What this could lead to
If it works, this could point toward a treatment that restores some vision after sudden blindness caused by giant cell arteritis.
What could go wrong
This is a very small early-phase trial with only 8 participants, so results may not apply widely. Bosentan also carries risks like liver toxicity and may not improve vision at all.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

8 people

The number who actually took part.

Started

Feb 2020

Finished

Jul 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Decreased visual acuity (BVA) \<5 days, regardless of degree of severity, abrupt onset in the context of newly diagnosed or suspected Horton's disease at this loss of visual acuity * Able to sign the consent * Affiliated to the social security system * Already under conventional treatment of Horton's disease or the: requiring: Corticosteroids and + - anti-platelet aggregators and / or LMWH at the discretion of the referring physician for its vasculitis and + - immunosuppressive or biotherapy if necessary. Exclusion Criteria: * Underlying hepatocellular insufficiency known * Patient under guardianship or curator * Hypersensitivity to the active substance or to any of the excipients * Moderate to severe hepatic insufficiency corresponding to class B or C of the Child-Pugh classification * Any other ophthalmological pathology explaining the sudden drop in vision: retinal detachment, retinal hemorrhage, posterior uveitis, nonarteritic arterial occlusion, cortical stroke * Serum levels of hepatic aminotransferases, aspartate aminotransferases (ASTs) and / or alanine aminotransferases (ALATs), greater than 3 times the upper limit of normal before start of treatment * Patient under treatment with cyclosporine A, antiretrovirals, glibenclamide or Rifampicin. * Pregnant or lactating women

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Conditions

The condition(s) this trial relates to.

blindness (disorder) Giant Cell Arteritis temporal arteritis Vision, Low

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • CH de Cannes

    Cannes, France