Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Cenaug Foundation | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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).
Main outcome parameters are:
(*)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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| longterm treatment group | previous treatment (before Optical Coherence Tomography angiography (OCTA)) >20 injections |
| |
| shortterm treatment group | previous treatment (before Optical Coherence Tomography angiography (OCTA)) < 5 injections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optical Coherence Tomography angiography (OCTA) | Diagnostic Test | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Peripapillary and perifoveal retinal nerve fiber layer (RNFL) thickness (µm) as evaluated by OCT (single measurement at study visit) | in both groups (longterm treatment group ( ≥20 intravitreal injections) and shortterm treatment group (<5 intravitreal injections). | 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) |
Not provided
Inclusion Criteria:
To be eligible for participation, patients will be required to
Exclusion Criteria:
diagnosis of glaucoma/ocular hypertension at baseline of anti-VEGF treatment
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Katja Hatz, MD | Vista Klinik Binningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vista Klinik | Binningen | Basel-Landschaft | 4102 | Switzerland |
if necessary on request
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
in both groups (longterm treatment group ( ≥20 intravitreal injections) and shortterm treatment group (<5 intravitreal injections). |
| baseline V0 |
| weight | weight meassurements in kg | baseline V0 |
| height | height meassurements in cm | baseline V0 |