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
Sponsor study identifier
observational
40
1 country
1
Study Start
January 7, 2019
Actual (reported)Primary Completion
April 2, 2019
Actual (reported)Study Completion
May 30, 2019
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 30, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 27, 2018
Actual (reported)January 7, 2019
Actual (reported)February 7, 2019
Actual (reported)April 2, 2019
Actual (reported)May 30, 2019
Actual (reported)Vessel Perfusion Area (%) and Flux index* of central ETDRS subfields and peripapillary region (single measurements at study visit), respectively, in both groups
in both groups (longterm treatment group ( ≥20 intravitreal injections) and shortterm treatment group (\<5 intravitreal injections).
baseline V0
Peripapillary and perifoveal retinal nerve fiber layer (RNFL) thickness (µm) as evaluated by OCT (single measurement at study visit)
baseline V0
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)
baseline V0
weight
baseline V0
height
baseline V0
previous treatment (before Optical Coherence Tomography angiography (OCTA)) \>20 injections
previous treatment (before Optical Coherence Tomography angiography (OCTA)) \< 5 injections
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Consecutive recruitment. All patients from Vista Klinik attending the retina outpatient clinic, who fulfil the in- and exclusion criteria, will be offered the participation in the study.
Vista Klinik
Binningen, Basel-Landschaft, 4102, Switzerland
Katja Hatz, MD
Vista Klinik Binningen
40 participants (actual enrollment reported by the registry).
First Submitted
December 27, 2018
First Posted
February 7, 2019
Study Start
January 7, 2019
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
April 2, 2019
Actual (reported)Study Completion
May 30, 2019
Actual (reported)Last Updated
October 1, 2019
Record last verified: 2019-09
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Source: ClinicalTrials.gov.
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