Non-invasive Optical Angiography in Age-related Macular Degeneration

Recruiting

• Conditions: Age Related Macular Degeneration
• Interventions: Other: Non-invasive OCT based optical angiography; Other: Oxymap T1; Other: OCT; Other: FLA/ICG angiography

• Registration Number: NCT02521142
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-03
• Study First Submitted QC: 2015-08-07
• Study First Posted: 2015-08-13
• Study Start: 2015-11
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-13
• Last Update Posted: 2023-01-17
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AMD: treatment-naive	Non-invasive OCT based optical angiography	-
AMD: active neovascular AMD	Non-invasive OCT based optical angiography	-
AMD: active neovascular AMD	FLA/ICG angiography	-
AMD: treatment-naive	FLA/ICG angiography	-
AMD: active neovascular AMD	OCT	-
AMD: treatment-naive	Oxymap T1	-
AMD: treatment-naive	OCT	-
AMD: active neovascular AMD	Oxymap T1	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
choroidal thickness as assessed with OCT	participants will be followed for the duration of outpatient clinic visit, an expected average of 1 days
peripapillarly bloodflow as assessed with Doppler OCT	participants will be followed for the duration of outpatient clinic visit, an expected average of 1 days

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria