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

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).

Study Overview

• Status: Completed
• Conditions: Neovascular Age-related Macular Degeneration
• Intervention / Treatment: Diagnostic test: 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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Switzerland
  • Baselland
    • Binningen, Baselland, Switzerland, 4102
      • Vista Klinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
longterm treatment group; previous treatment (before Optical Coherence Tomography angiography (OCTA)) >20 injections	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).
shortterm treatment group; previous treatment (before Optical Coherence Tomography angiography (OCTA)) < 5 injections	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Dr. med. Katja Hatz
• Collaborators: Cenaug Foundation
• Investigators: Principal Investigator: Katja Hatz, MD, Vista Klinik Binningen

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2019
• Primary Completion (Actual): April 2, 2019
• Study Completion (Actual): May 30, 2019

Study Registration Dates

• First Submitted: December 27, 2018
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (Actual): February 7, 2019

Study Record Updates

• Last Update Posted (Actual): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 30, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: OCTA 2018-02043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: if necessary on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No