Non-arteritic Ischemic Optic NeuropathyNARROWNCT05305079
NA-AION Risk Factors: New Perspectives
An observational study of Non-arteritic Ischemic Optic Neuropathy and Optic Disk Drusen, run by Copenhagen University Hospital, Rigshospitalet at 20 sites in 9 countries.
Trial summary
The purpose of the study is to use new diagnostic methods (OCT and OCT-A) to shed light on risk factors for the development of NA-AION. The risk factors we are focusing on are comorbidities along with anatomical and vascular characteristics of the optic nerve. Read more about this study
- Who is it for?
- Ages 11 years and older
- Conditions the study is for
- Non-arteritic Ischemic Optic Neuropathy, Optic Disk Drusen
- How many people
- 179 participants
- Where
- 20 sitesin 9 countries
- Study dates
- 1 Aug 2021to 31 Aug 2024
- Phase
- Observational
- 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 11 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population is patients diagnosed with NA-AION in a 1.5-year inclusion period.
Who may be able to join
- Diagnosis of first episode of NA-AION in study eye with symptom onset within 1 month prior
- Subject age: Age >10
- NA-AION diagnosis requires:
- disc edema seen by site PI or by referring doctor
- visual field defect in the study eye consistent with NA-AION and mean deviation worse than 3.0 dB using the study visual field examination protocol
- relative afferent pupillary defect (unless the fellow eye had previous NA-AION or other optic nerve or retinal disease that is not exclusionary)
Who cannot join
- Previous episode of NA-AION in the study eye only
- Intraocular pressure of >21 mm Hg in the study eye
- Clinical or pathological evidence of giant cell arteritis
- Diseases that may affect the optic nerve: glaucoma, multiple sclerosis, Alzheimer disease, and Parkinson disease. Evidence of optic disc drusen and optic nerve hypoplasia are not exclusion criteria given they are important parts of the study. We will not exclude significant retinal diseases, since they may be related to underlying etiologies giving rise to ODD, such as macular degeneration, retinal dystrophies, but eyes with significant retinal diseases will be analyzed separately.
Trial locations and contacts
20 sites in 9 countries.
20 sites in 9 countries
United States5 sites
Massachusetts Eye and Ear
Boston, Massachusetts, 02114
University og Colorado
Boulder, Colorado, 80309
Stanford Medicine
Palo Alto, California, 94305
John A. Moran Eye Center
Salt Lake City, Utah, 84132
UCSF Medical Center
San Francisco, California, 94143
Denmark4 sites
Aalborg University Hospital
Aalborg
Aarhus University Hospital
Aarhus
Odense University Hospital
Odense
Zealand University Hospital
Roskilde
Canada3 sites
University of Calgary
Calgary
Research St. Joseph's
Hamilton
Lawson Health Research Institute
London
United Kingdom3 sites
University of Cambridge
Cambridge
King's College Hospital
London
Moorfield's Eye Hospital
London
About this study
Official title: Non-Arteritic Anterior Ischemic Optic Neuropathy Risk Factors: New Perspectives
The purpose of the study is to use new diagnostic methods (OCT and OCT-A) to shed light on risk factors for the development of NA-AION. The risk factors we are focusing on are comorbidities along with anatomical and vascular characteristics of the optic nerve.
Read the detailed description
Non-arteritic anterior ischemic optic neuropathy (NA-AION) is the most common acute optic neuropathy in the middle-aged and elderly population and can also occur in children and young adults. NA-AION leads to irreversible vision loss, and there is currently no effective treatment. In recent years, acellular calcified deposits in the optic nerve head called optic disc drusen (ODD) have been investigated as an important risk factor for NA-AION in patients under the age of 50.
The purpose of the study is to use new diagnostic methods optical coherence tomography (OCT) and OCT-angiography (OCTA) to shed light on risk factors for the development of NA-AION. We will perform two sub-studies:
- Characteristics of the optic nerve head anatomy including the presence of ODD as risk factors for the development of NA-AION.
- Vascular comorbidities and in vivo vasculature as a risk factor for developing NA-AION.
The study is an international prospective multicenter study including 20 sites in 9 different countries. The study population is patients diagnosed with NA-AION in a 1.5-year inclusion period. Each included patient gets 1-2 follow up visits during a 3-month follow up time.
Included patients will be examined as per standard clinical care for that site including OCT and OCT-A. Standard clinical care includes at least: obtaining medical history, measurement of visual acuity, slit lamp examination, and automated perimetry.
Characteristics and risk factors in NA-AION patients with ODD (ODD-AION) will be compared with NA-AOIN patients without ODD (nODD-AION).
- Keywords
- Optical Coherence Tomography, Optical Coherence Tomography Angiography
- Medical subject headings
- Optic Disk Drusen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ODD-AION | NA-AION patients with ODD aka. Optic disc drusen associated non-arteritic anterior ischemic optic neuropathy. | |
| nODD-AION | NA-AION patients without ODD aka Non-optic disc drusen associated non-arteritic anterior ischemic optic neuropathy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical characteristics on OCT
Presence of ODD. Diameter of the scleral canal, disc area and rim on each quadrant of the optic disc, thickness of the peripapillary choroid, presence of peripapillary hyperreflective ovoid mass-like structures, and prelaminar hyperreflective lines.
Measured: At enrollment
Anatomical characteristics on OCT
Presence of ODD. Diameter of the scleral canal, disc area and rim on each quadrant of the optic disc, thickness of the peripapillary choroid, presence of peripapillary hyperreflective ovoid mass-like structures, and prelaminar hyperreflective lines.
Measured: 3-months follow-up visit
Vascular characteristics on OCT-A
Transient versus persistent findings of ischemia, segmental location and extent of reduced vessel density. If ODD is present the vessel density will be compared to ODD location and volume.
Measured: 3-months follow-up visit
Secondary outcomes (8)
ODD characteristics
If ODD is present the volume and location of the ODD (superficial vs. deep) is measured using 3D-segmentation
Measured: At 3-months follow-up visit
Best corrected visual acuity
Assessed on Snellen or ETDRS chart
Measured: At enrollment
Best corrected visual acuity
Assessed on Snellen or ETDRS chart
Measured: 3-months follow-up visit
Visual field test
Autoperimetry: SITA fast or standard 24-2
Measured: At enrollment
Visual field test
Autoperimetry: SITA fast or standard 24-2
Measured: 3-months follow-up visit
Questionnaire score: NEI-VFQ-25 including 10-item NO supplement score
Score on questionnaire: National Eye Institute Visual Function Questionnaire 25 and 10-item Neuro-Ophthalmic Supplement
A vision-targeted composite score of the NEI-VFQ-25 together with the 10-item NO supplement score is calculated. The scale is 0-100 where a high score represents better functioning.
Measured: At enrollment
Questionnaire score: NEI-VFQ-25 including 10-item NO supplement score
Score on questionnaire: National Eye Institute Visual Function Questionnaire 25 and 10-item Neuro-Ophthalmic Supplement.
A vision-targeted composite score of the NEI-VFQ-25 together with the 10-item NO supplement score is calculated. The scale is 0-100 where a high score represents better functioning.
Measured: 3-months follow-up visit
Prevalence of comorbidities
ischemic heart disease, stroke (ischemic or hemorrhagic), arterial hypertension, diabetes mellitus, end stage renal disease, smoking (now or previous), dyslipidemia, obstructive sleep apnea/continuous positive airway pressure (CPAP) use, phosphodiesterase-5 inhibitor use or ocular surgery.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Aug 2021
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-arteritic Ischemic Optic NeuropathyStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Velux Fonden, Fight for Sight, University of Copenhagen, Hamilton Health Sciences Corporation, Aarhus University Hospital, Aalborg University Hospital, Odense University Hospital, Farabi Eye Hospital, Wellington Hospital, University of Colorado, Denver, University of Utah, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's, University of Sydney, Stanford University, Moorfields Eye Hospital NHS Foundation Trust, Massachusetts Eye and Ear Infirmary, University Hospital, Bordeaux, Synoptik-Fonden
- Responsible party
- Principal investigator, Steffen Hamann, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Steffen Hamann, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305079
- Sponsor's protocol ID
- H-20073063
- Acronym
- NARROW
- Status last verified
- Mar 2022
- First submitted
- 26 Jul 2021
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Klefter ON, Hansen MS, Lykkebirk L, Subhi Y, Brittain JM, Jensen MR, Dohn UM, Fana V, Wiencke AK, Heegaard S, Terslev L, Hamann S. Combining Paracentral Acute Middle Maculopathy and Peripapillary Fluid as Biomarkers in Anterior Ischemic Optic Neuropathy. Am J Ophthalmol. 2025 Mar;271:329-336. doi: 10.1016/j.ajo.2024.12.001. Epub 2024 Dec 6.
PubMed 39645178
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Arteritic Anterior Ischemic Optic Neuropathy Risk Factors: New Perspectives
- ClinicalTrials.gov ID
- NCT05305079
- Acronym / sponsor ID
- NARROW / H-20073063
- Keywords
- Optical Coherence Tomography, Optical Coherence Tomography Angiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Velux Fonden, Fight for Sight, University of Copenhagen, Hamilton Health Sciences Corporation, Aarhus University Hospital, Aalborg University Hospital, Odense University Hospital, Farabi Eye Hospital, Wellington Hospital, University of Colorado, Denver, University of Utah, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's, University of Sydney, Stanford University, Moorfields Eye Hospital NHS Foundation Trust, Massachusetts Eye and Ear Infirmary, University Hospital, Bordeaux, Synoptik-Fonden
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 31 Mar 2022 (actual)
- 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 purpose of the study is to use new diagnostic methods (OCT and OCT-A) to shed light on risk factors for the development of NA-AION. The risk factors we are focusing on are comorbidities along with anatomical and vascular characteristics of the optic nerve.
Detailed description
Non-arteritic anterior ischemic optic neuropathy (NA-AION) is the most common acute optic neuropathy in the middle-aged and elderly population and can also occur in children and young adults. NA-AION leads to irreversible vision loss, and there is currently no effective treatment. In recent years, acellular calcified deposits in the optic nerve head called optic disc drusen (ODD) have been investigated as an important risk factor for NA-AION in patients under the age of 50.
The purpose of the study is to use new diagnostic methods optical coherence tomography (OCT) and OCT-angiography (OCTA) to shed light on risk factors for the development of NA-AION. We will perform two sub-studies:
- Characteristics of the optic nerve head anatomy including the presence of ODD as risk factors for the development of NA-AION.
- Vascular comorbidities and in vivo vasculature as a risk factor for developing NA-AION.
The study is an international prospective multicenter study including 20 sites in 9 different countries. The study population is patients diagnosed with NA-AION in a 1.5-year inclusion period. Each included patient gets 1-2 follow up visits during a 3-month follow up time.
Included patients will be examined as per standard clinical care for that site including OCT and OCT-A. Standard clinical care includes at least: obtaining medical history, measurement of visual acuity, slit lamp examination, and automated perimetry.
Characteristics and risk factors in NA-AION patients with ODD (ODD-AION) will be compared with NA-AOIN patients without ODD (nODD-AION).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ODD-AION | – | –NA-AION patients with ODD aka. Optic disc drusen associated non-arteritic anterior ischemic optic neuropathy. |
| nODD-AION | – | –NA-AION patients without ODD aka Non-optic disc drusen associated non-arteritic anterior ischemic optic neuropathy. |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population is patients diagnosed with NA-AION in a 1.5-year inclusion period.
Key inclusion criteria (6 listed)
- Diagnosis of first episode of NA-AION in study eye with symptom onset within 1 month prior
- Subject age: Age >10
- NA-AION diagnosis requires:
Key exclusion criteria (4 listed)
- Previous episode of NA-AION in the study eye only
- Intraocular pressure of >21 mm Hg in the study eye
- Clinical or pathological evidence of giant cell arteritis
- Diseases that may affect the optic nerve: glaucoma, multiple sclerosis, Alzheimer disease, and Parkinson disease. Evidence of optic disc drusen and optic nerve hypoplasia are not exclusion criteria given they are important parts of the study. We will not exclude significant retinal diseases, since they may be related to underlying etiologies giving rise to ODD, such as macular degeneration, retinal dystrophies, but eyes with significant retinal diseases will be analyzed separately.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anatomical characteristics on OCT
Time frame: At enrollment
Presence of ODD. Diameter of the scleral canal, disc area and rim on each quadrant of the optic disc, thickness of the peripapillary choroid, presence of peripapillary hyperreflective ovoid mass-like structures, and prelaminar hyperreflective lines.
Anatomical characteristics on OCT
Time frame: 3-months follow-up visit
Presence of ODD. Diameter of the scleral canal, disc area and rim on each quadrant of the optic disc, thickness of the peripapillary choroid, presence of peripapillary hyperreflective ovoid mass-like structures, and prelaminar hyperreflective lines.
Vascular characteristics on OCT-A
Time frame: 3-months follow-up visit
Transient versus persistent findings of ischemia, segmental location and extent of reduced vessel density. If ODD is present the vessel density will be compared to ODD location and volume.
8 secondary outcomes
ODD characteristics
Time frame: At 3-months follow-up visit
Best corrected visual acuity
Time frame: At enrollment
Best corrected visual acuity
Time frame: 3-months follow-up visit
Visual field test
Time frame: At enrollment
Visual field test
Time frame: 3-months follow-up visit
Questionnaire score: NEI-VFQ-25 including 10-item NO supplement score
Time frame: At enrollment
Questionnaire score: NEI-VFQ-25 including 10-item NO supplement score
Time frame: 3-months follow-up visit
Prevalence of comorbidities
Time frame: At enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Derived from this study: PubMed 39645178Klefter ON, Hansen MS, Lykkebirk L, Subhi Y, Brittain JM, Jensen MR, Dohn UM, Fana V, Wiencke AK, Heegaard S, Terslev L, Hamann S. Combining Paracentral Acute Middle Maculopathy and Peripapillary Fluid as Biomarkers in Anterior Ischemic Optic Neuropathy. Am J Ophthalmol. 2025 Mar;271:329-336. doi: 10.1016/j.ajo.2024.12.001. Epub 2024 Dec 6.
Related trials for Non-arteritic Ischemic Optic Neuropathy
RecruitingPhase 3
Efficacy and Safety of Intranasal Cenegermin in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
Non-Arteritic Anterior Ischemic Optic Neuropathy
RecruitingPhase 1
Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Exosomes for NAION
Eye Diseases, Retinitis Pigmentosa
Not yet recruitingObservational study
NAION in Non-Diabetic Obese Patients Using GLP-1 Receptor Agonists: A Real-World Study
Non-arteritic Anterior Ischemic Optic Neuropathy Obesity, Obesity
Recruiting
Stem Cell Ophthalmology Treatment Study II
Retinal Disease, Age-Related Macular Degeneration
RecruitingPhase 1
Evaluating ER-100 for Safety in People With Glaucoma or Non-Arteritic Anterior Ischemic Optic Neuropathy (Optic Nerve Conditions)
Open Angle Glaucoma (OAG), NAION( Non-arteritic Anterior Ischemic Optic Neuropathy)
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.
Steffen Hamann principal investigator
Copenhagen University Hospital, Rigshospitalet
20 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-arteritic Ischemic Optic Neuropathy and Optic Disk Drusen, run by Copenhagen University Hospital, Rigshospitalet at 20 sites in 9 countries.
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Denmark, Canada, United Kingdom, Australia and 4 more countries. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anatomical characteristics on OCT (time frame: At enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05305079, which also lists 1 linked publication.
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 22 Nov 2024.