Non-invasive Optical Angiography in Age-related Macular Degeneration

Medical University of Vienna

Status: Enrolling

Conditions: Age Related Macular Degeneration

Treatments: Other: Non-invasive OCT based optical angiography; Other: OCT; Other: FLA/ICG angiography; Other: Oxymap T1

Study type: Observational

Funder types: Other

Identifiers

NCT02521142

NOAA

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

72 participants in 2 patient groups

AMD: treatment-naive

Treatment:

Other: OCT

Other: Non-invasive OCT based optical angiography

Other: Oxymap T1

Other: FLA/ICG angiography

AMD: active neovascular AMD

Treatment:

Other: OCT

Other: Non-invasive OCT based optical angiography

Other: Oxymap T1

Other: FLA/ICG angiography