Age Related Macular DegenerationNCT02521142
Non-invasive Optical Angiography in Age-related Macular Degeneration
An observational study of Age Related Macular Degeneration, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Age-related macular degeneration (AMD) is the leading cause of severe and irreversible visual loss and classified blindness in the elderly throughout Europe and the US. Among these patients, about 6%-8% are afflicted with the advanced stages of AMD, which are responsible for the most severe visual loss. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- Non-invasive OCT based optical angiography, Oxymap T1 and OCT
- How many people
- 72 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2015to Dec 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with CNV due to AMD both, treatment naive and active CNV being treated
Who may be able to join
- Patients with active CNV due to AMD as assessed by FLA/ICG angiography within 1 week prior to study inclusion
Who cannot join
- Any of the following will exclude a patient from the study:
- Previous application of intravitreal drugs except anti-VEGF injections
- Active intraocular inflammation
- Presence of an intraocular disease except AMD and cataract
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Reinhard Told, MD, PhD, +43140400 ext. 48470
About this study
Age-related macular degeneration (AMD) is the leading cause of severe and irreversible visual loss and classified blindness in the elderly throughout Europe and the US. Among these patients, about 6%-8% are afflicted with the advanced stages of AMD, which are responsible for the most severe visual loss. There is now convincing evidence that vascular endothelial growth factor (VEGF) is a major trigger for the formation of pathological choroidal vessels, responsible for the development of the neovascular form of AMD. Today, the gold standard for vascular imaging of the retina and diagnosis of CNV is angiography using fluorescein (FLA) or indocyanine green (ICG), which involves injection of the dye into a vein of the arm. In the recent years tremendous enhancements in the field of optical coherence tomography have been achieved. These developments made it possible to visualize the retinal vasculature in a full depth manner without the application of an intravenous marker. The proposed study tests the hypothesis that visualisation of CNV lesion size with non-invasive OCT angiography is not inferior to FLA/ICG angiography in treatment naïve and previously treated AMD patients.
- Conditions
- Age Related Macular Degeneration
- Being tested
- Non-invasive OCT based optical angiography, Oxymap T1, OCT, FLA/ICG angiography
- Keywords
- OCT Angiography
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive OCT based optical angiographyOther
This measurement will be obtained after the dilation of the pupil. Optical coherence tomography (OCT) is a non-invasive optical imaging modality enabling cross-sectional tomographic in vivo visualization of internal microstructure in biological systems. In ophthalmology OCT has become a standard device in visualizing the retina and is also considered a standard tool in the diagnosis of retinal disease. In optical angiography blood vessels contrasting against static tissue are visualized in a full depth resolved and label-free manner.
Oxymap T1Other
The Oxymap system T1 is installed on a conventional fundus camera (Topcon TRC-50DX), which is operated as for color photography. The Oxymap T1 simultaneously acquires two images of the same area of the fundus at two different wavelengths of light. One of the two wavelengths is sensitive to oxygen saturation, i.e. the light absorbance changes with the oxygen saturation, while the other is insensitive to oxygen saturation and is used to calibrate the light intensity. The two spectral images are automatically processed by the Oxymap Analyzer software. Oxymap Analyzer detects blood vessels and estimates the light absorbance (optical density) at each point along the vessels at each wavelength. The ratio of the optical densities (optical density ratio or ODR) has been shown to be linearly related to hemoglobin oxygen saturation.
OCTOther
non-invasive imaging of retinal and choroidal structures.
FLA/ICG angiographyOther
Fluorescein Angiography and Indocianine Angiography
| Study group | Role | What they receive |
|---|---|---|
| AMD: treatment-naive | Not described Receives: Other: Non-invasive OCT based optical angiography; Other: Oxymap T1; Other: OCT; Other: FLA/ICG angiography | |
| AMD: active neovascular AMD | Not described Receives: Other: Non-invasive OCT based optical angiography; Other: Oxymap T1; Other: OCT; Other: FLA/ICG angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in visualization of lesion size between non-invasive OCT based optical angiography and FLA/ICG angiography in treatment-naïve and treated patients with CNV due to AMD.
Measured: Participants will be followed for the duration of outpatient clinic visit, an expected average of 1 days
Secondary outcomes (2)
choroidal thickness as assessed with OCT
Measured: participants will be followed for the duration of outpatient clinic visit, an expected average of 1 days
peripapillarly bloodflow as assessed with Doppler OCT
Measured: participants will be followed for the duration of outpatient clinic visit, an expected average of 1 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
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 Age Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Sacu, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521142
- Sponsor's protocol ID
- NOAA
- Status last verified
- Jan 2023
- First submitted
- 3 Aug 2015
- Last updated
- 17 Jan 2023
- Results posted
- No
Publications
Told R, Reumueller A, Schranz M, Brugger J, Weigert G, Reiter GS, Sacu S, Schmidt-Erfurth U. OCTA Biomarker Search in Patients with nAMD: Influence of Retinal Fluid on Time-Dependent Biomarker Response. Curr Eye Res. 2023 Jun;48(6):600-604. doi: 10.1080/02713683.2023.2184318. Epub 2023 Mar 9.
PubMed 36891909
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Optical Angiography in Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT02521142
- Acronym / sponsor ID
- NOAA
- Conditions
- Age Related Macular Degeneration
- Keywords
- OCT Angiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 13 Aug 2015 (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.
Age-related macular degeneration (AMD) is the leading cause of severe and irreversible visual loss and classified blindness in the elderly throughout Europe and the US. Among these patients, about 6%-8% are afflicted with the advanced stages of AMD, which are responsible for the most severe visual loss. There is now convincing evidence that vascular endothelial growth factor (VEGF) is a major trigger for the formation of pathological choroidal vessels, responsible for the development of the neovascular form of AMD. Today, the gold standard for vascular imaging of the retina and diagnosis of CNV is angiography using fluorescein (FLA) or indocyanine green (ICG), which involves injection of the dye into a vein of the arm. In the recent years tremendous enhancements in the field of optical coherence tomography have been achieved. These developments made it possible to visualize the retinal vasculature in a full depth manner without the application of an intravenous marker. The proposed study tests the hypothesis that visualisation of CNV lesion size with non-invasive OCT angiography is not inferior to FLA/ICG angiography in treatment naïve and previously treated AMD patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMD: treatment-naive | – | Other: Non-invasive OCT based optical angiography, Other: Oxymap T1, Other: OCT, Other: FLA/ICG angiography |
| AMD: active neovascular AMD | – | Other: Non-invasive OCT based optical angiography, Other: Oxymap T1, Other: OCT, Other: FLA/ICG angiography |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with CNV due to AMD both, treatment naive and active CNV being treated
Key inclusion criteria (1 listed)
- Patients with active CNV due to AMD as assessed by FLA/ICG angiography within 1 week prior to study inclusion
Key exclusion criteria (4 listed)
- Previous application of intravitreal drugs except anti-VEGF injections
- Active intraocular inflammation
- Presence of an intraocular disease except AMD and cataract
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 |
|---|---|---|
| Non-invasive OCT based optical angiographyThis measurement will be obtained after the dilation of the pupil. Optical coherence tomography (OCT) is a non-invasive optical imaging modality enabling cross-sectional tomographic in vivo visualization of internal microstructure in biological systems. In ophthalmology OCT has become a standard device in visualizing the retina and is also considered a standard tool in the diagnosis of retinal disease. In optical angiography blood vessels contrasting against static tissue are visualized in a full depth resolved and label-free manner. | Other | AMD: active neovascular AMD, AMD: treatment-naive |
| Oxymap T1The Oxymap system T1 is installed on a conventional fundus camera (Topcon TRC-50DX), which is operated as for color photography. The Oxymap T1 simultaneously acquires two images of the same area of the fundus at two different wavelengths of light. One of the two wavelengths is sensitive to oxygen saturation, i.e. the light absorbance changes with the oxygen saturation, while the other is insensitive to oxygen saturation and is used to calibrate the light intensity. The two spectral images are automatically processed by the Oxymap Analyzer software. Oxymap Analyzer detects blood vessels and estimates the light absorbance (optical density) at each point along the vessels at each wavelength. The ratio of the optical densities (optical density ratio or ODR) has been shown to be linearly related to hemoglobin oxygen saturation. | Other | AMD: active neovascular AMD, AMD: treatment-naive |
| OCTnon-invasive imaging of retinal and choroidal structures. | Other | AMD: active neovascular AMD, AMD: treatment-naive |
| FLA/ICG angiographyFluorescein Angiography and Indocianine Angiography | Other | AMD: active neovascular AMD, AMD: treatment-naive |
Primary outcome
Differences in visualization of lesion size between non-invasive OCT based optical angiography and FLA/ICG angiography in treatment-naïve and treated patients with CNV due to AMD.
Time frame: Participants will be followed for the duration of outpatient clinic visit, an expected average of 1 days
2 secondary outcomes
choroidal thickness as assessed with OCT
Time frame: participants will be followed for the duration of outpatient clinic visit, an expected average of 1 days
peripapillarly bloodflow as assessed with Doppler OCT
Time frame: participants will be followed for the duration of outpatient clinic visit, an expected average of 1 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Derived from this study: PubMed 36891909Told R, Reumueller A, Schranz M, Brugger J, Weigert G, Reiter GS, Sacu S, Schmidt-Erfurth U. OCTA Biomarker Search in Patients with nAMD: Influence of Retinal Fluid on Time-Dependent Biomarker Response. Curr Eye Res. 2023 Jun;48(6):600-604. doi: 10.1080/02713683.2023.2184318. Epub 2023 Mar 9.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age Related Macular Degeneration, run by Medical University of Vienna at 1 site in Austria.
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 1 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: status not confirmed, as of the sponsor's last update on 17 Jan 2023. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Pollreisz, MD (+4314040048470, andreas.pollreisz@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in visualization of lesion size between non-invasive OCT based optical angiography and FLA/ICG angiography in treatment-naïve and treated patients with CNV due to AMD. (time frame: Participants will be followed for the duration of outpatient clinic visit, an expected average of 1 days). 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 NCT02521142, 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 17 Jan 2023.