NCT03833830

Vessel Density in nAMD After Longterm Anti-VEGF Treatment Compared to Recently Started Anti-VEGF Treatment

A Cross Sectional Study Assessing the Perifoveal and Peripapillar Vessel Density in nAMD After Longterm Anti-VEGF Treatment Compared to Recently Started Anti-VEGF Treatment - Pilotstudy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Dr. med. Katja Hatz · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Neovascular age-related macular degeneration (nAMD) is characterized by the abnormal growth of blood vessels from the choroid into the subretinal space which leads to sub- and intraretinal fluid accumulation, hemorrhages and subretinal fibrosis with progressive loss of central vision. Intravitreal anti-VEGF treatment is the standard of care. Intravitreal anti-VEGF application might temporarily increase intraocular pressure due to a volume effect. It remains unclear if repeated injections might have an impact on retinal capillary perfusion. Therefore this study aims to investigate the vascular microcirculation differences between patients who received longterm intravitreal Anti-VEGF treatment and patients who recently started Anti-VEGF treatment using Optical Coherence tomography Angiography (OCTA).

Detailed description

Main outcome parameters are: * Vessel Perfusion Area (%) of central ETDRS subfields and peripapillar region as evaluated by OCTA (single measurement) * Blood flux index(\*) of central ETDRS subfields and peripapillar region as evaluated by OCTA (single measurement). * Peripapillary and perifoveal retinal nerve fiber layer (RNFL) thickness (µm) as evaluated by OCT (single measurement) * Intraocular pressure (IOP) (mmHg) (single measurement at study visit) and mean intraocular pressure during anti-VEGF treatment period (evaluated as mean of all retrospectively available IOP measures from the beginning of treatment, mmHg) (\*)Blood flux index is automatically calculated by ARI Network as the mean flow intensity in the vessel area, where the blood flow signal was normalized to 0 to 1 by dividing by the full dynamic range of blood flow signal intensity.

Conditions

• Neovascular Age-related Macular Degeneration

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Optical Coherence Tomography angiography (OCTA)	There will be an OCTA measurement (observational study) for both groups. Group allocation will be made due to previous anti-VEGF treatments (longterm treatment group \>20 injections and shortterm treatment group \< 5 injections).

Timeline

• Start date: 2019-01-07
• Primary completion: 2019-04-02
• Completion: 2019-05-30
• First posted: 2019-02-07
• Last updated: 2019-10-01

Locations

1 site across 1 country: Switzerland