Optic Disc SwellingPhase 4AAMPTCNCT02149615
Antiacne Medications Pseudotumor Cerebri
A Phase 4 study testing Retinal nerve fibre layer measurement in people with Optic Disc Swelling, run by University of Zurich at 1 site in Switzerland.
Trial summary
The exact incidence of optic disc swelling and idiopathic intracranial hypertension in patients using antiacne medication is not known so far. The investigators hypothesize that swelling of retinal nerve fibre layer measured by optical coherence tomography is more frequent then assumed so far. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Optic Disc Swelling
- What is being tested?
- Retinal nerve fibre layer measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2014to Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Antiacne medication treatment indicated by dermatologist
- age > 18 years
- contraception if indicated
Who cannot join
- age < 18 years
Trial locations and contacts
1 site in 1 country.
Isabelle Meneau contact
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, Canton of Zurich, 8091
Isabelle Meneau, isabelle.meneau@usz.ch
Gregor Jaggi, MD
About this study
Official title: Prospective Open-label Phase IV Trial to Investigate the Frequency of Optic Disc Swelling, Idiopathic Intracranial Hypertension and Dry Eye Symptoms Under Antiacne Medication Treatment
The exact incidence of optic disc swelling and idiopathic intracranial hypertension in patients using antiacne medication is not known so far. The investigators hypothesize that swelling of retinal nerve fibre layer measured by optical coherence tomography is more frequent then assumed so far.
Read the detailed description
Measurement of retinal nerve fibre layer using optical coherence tomography over a period of 6 to 9 months depending on exact antiacne medication.
- Conditions
- Optic Disc Swelling
- Being tested
- Retinal nerve fibre layer measurement
- Keywords
- idiopathic intracranial hypertension, optic disc swelling, antiacne medication, isotretinoin
- Medical subject headings
- Papilledema, Pseudotumor Cerebri
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retinal nerve fibre layer measurementOther
Also called effect of medication on optic nerve fibre layer
Measurement of retinal nerve fibre layer thickness using optic coherence tomography.
| Study group | Role | What they receive |
|---|---|---|
| isotretinoin | Experimental | Retinal nerve fibre layer measurement in patients under isotretinoin treatment Receives: Other: Retinal nerve fibre layer measurement |
| lymecycline | Active comparator | Retinal nerve fibre layer measurement in patients under lymecycline treatment Receives: Other: Retinal nerve fibre layer measurement |
| minocycline | Active comparator | Retinal nerve fibre layer measurement in patients under minocycline treatment Receives: Other: Retinal nerve fibre layer measurement |
| doxycycline | Active comparator | Retinal nerve fibre layer measurement in patients under doxycycline treatment Receives: Other: Retinal nerve fibre layer measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal nerve fibre layer
Measurement of retinal nerve fibre layer using optical coherence tomography. Changes over 10 micrometers are considered to be clinically relevant.
The Term "retinal nerve fibre layer" describes an automated standardized optical coherence tomography measurement program measuring the sectorial thickness of the peripapillar retinal nerve fibre layer. There exists no other term for that.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic Disc SwellingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Zürich
- Responsible party
- Sponsor
- Investigators
- Klara Landau, Prof MD, Study chair, UniversityHospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149615
- Sponsor's protocol ID
- KEK-ZH 2013-0433 AAMPTC
- Other IDs
- 2013DR4066
- Acronym
- AAMPTC
- Status last verified
- May 2014
- First submitted
- 7 Apr 2014
- Last updated
- 29 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Open-label Phase IV Trial to Investigate the Frequency of Optic Disc Swelling, Idiopathic Intracranial Hypertension and Dry Eye Symptoms Under Antiacne Medication Treatment
- ClinicalTrials.gov ID
- NCT02149615
- Acronym / sponsor ID
- AAMPTC / KEK-ZH 2013-0433 AAMPTC
- Conditions
- Optic Disc Swelling
- Keywords
- idiopathic intracranial hypertension, optic disc swelling, antiacne medication, isotretinoin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- University Hospital, Zürich
- Study start
- Apr 2014
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 29 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The exact incidence of optic disc swelling and idiopathic intracranial hypertension in patients using antiacne medication is not known so far. The investigators hypothesize that swelling of retinal nerve fibre layer measured by optical coherence tomography is more frequent then assumed so far.
Detailed description
Measurement of retinal nerve fibre layer using optical coherence tomography over a period of 6 to 9 months depending on exact antiacne medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| isotretinoin | Experimental | Other: Retinal nerve fibre layer measurementRetinal nerve fibre layer measurement in patients under isotretinoin treatment |
| lymecycline | Active comparator | Other: Retinal nerve fibre layer measurementRetinal nerve fibre layer measurement in patients under lymecycline treatment |
| minocycline | Active comparator | Other: Retinal nerve fibre layer measurementRetinal nerve fibre layer measurement in patients under minocycline treatment |
| doxycycline | Active comparator | Other: Retinal nerve fibre layer measurementRetinal nerve fibre layer measurement in patients under doxycycline treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Antiacne medication treatment indicated by dermatologist
- age > 18 years
- contraception if indicated
Key exclusion criteria (1 listed)
- age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retinal nerve fibre layer measurementAlso: effect of medication on optic nerve fibre layerMeasurement of retinal nerve fibre layer thickness using optic coherence tomography. | Other | doxycycline, isotretinoin, lymecycline, minocycline |
Primary outcome
Retinal nerve fibre layer
Time frame: 9 months
Measurement of retinal nerve fibre layer using optical coherence tomography. Changes over 10 micrometers are considered to be clinically relevant. The Term "retinal nerve fibre layer" describes an automated standardized optical coherence tomography measurement program measuring the sectorial thickness of the peripapillar retinal nerve fibre layer. There exists no other term for that.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2014.
- Study register SwitzerlandLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Meneau contact
Klara Landau, Prof MD study chair
UniversityHospital, Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Retinal nerve fibre layer measurement in people with Optic Disc Swelling, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gregor Jaggi, MD (0041 44 255 49 00, gregor.jaggi@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal nerve fibre layer (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2014.