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

Neovascular Age-related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03833830
• Other study ID #: OCTA 2018-02043
• Status: Completed
• Start date: January 7, 2019
• Est. completion date: May 30, 2019

Study information

• Verified date: September 2019
• Source: Vista Klinik
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 30, 2019
• Est. primary completion date: April 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

To be eligible for participation, patients will be required to

• have been treated for sub- or juxtafoveal CNV due to nAMD with anti-VEGF intravitreal injections either for at least 20 times (longterm treatment eyes) or <5 times (shortterm treatment eyes).

• give written consent to participation

Exclusion Criteria:

• diagnosis of glaucoma/ocular hypertension at baseline of anti-VEGF treatment

• history of retinal vascular disorders like diabetic retinopathy, retinal vein/arterial occlusive disease, uveitis etc.

• history of papillary disease which might interfere with interpretation of peripapillary OCT/OCTA evaluation such as severe tilted disc, parapapillar CNV, papillar drusen, optic nerve neuritis, papillar edema etc.

• inability to perform OCTA examination of sufficient quality.

• history of any side effects of Tropicamide eye drops

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration

Intervention

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).

Locations

Country	Name	City	State
Switzerland	Vista Klinik	Binningen	Baselland

Sponsors (2)

Lead Sponsor	Collaborator
Dr. med. Katja Hatz	Cenaug Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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)	in both groups (longterm treatment group ( =20 intravitreal injections) and shortterm treatment group (<5 intravitreal injections).	baseline V0
Secondary	weight	weight meassurements in kg	baseline V0
Secondary	height	height meassurements in cm	baseline V0