Non-invasive Optical Angiography in Age-related Macular Degeneration

Age Related Macular Degeneration Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02521142
• Other study ID #: NOAA
• Status: Recruiting
• Start date: November 2015
• Est. completion date: December 2023

Study information

• Verified date: January 2023
• Source: Medical University of Vienna
• Contact: Andreas Pollreisz, MD
• Phone: +4314040048470
• Email: andreas.pollreisz[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with active CNV due to AMD as assessed by FLA/ICG angiography within 1 week prior to study inclusion

Exclusion criteria

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

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Intervention

Other:
• Non-invasive OCT based optical angiography
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 T1
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.
• OCT
non-invasive imaging of retinal and choroidal structures.
• FLA/ICG angiography
Fluorescein Angiography and Indocianine Angiography

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Participants will be followed for the duration of outpatient clinic visit, an expected average of 1 days
Secondary	choroidal thickness as assessed with OCT		participants will be followed for the duration of outpatient clinic visit, an expected average of 1 days
Secondary	peripapillarly bloodflow as assessed with Doppler OCT		participants will be followed for the duration of outpatient clinic visit, an expected average of 1 days