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NCT Number: NCT03833830

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

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).

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Key information

Conditions

Neovascular Age-related Macular Degeneration

Sex eligibility

All sexes

Study type

Observational

Primary location

Vista Klinik

Binningen, Basel-Landschaft, 4102, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Vessel Perfusion Area (%) and Flux index* of central ETDRS subfields and peripapillary region (single measurements at study visit), respectively, in both groups

    Time frame: baseline V0

    in both groups (longterm treatment group ( ≥20 intravitreal injections) and shortterm treatment group (<5 intravitreal injections).

Secondary outcomes

  1. Peripapillary and perifoveal retinal nerve fiber layer (RNFL) thickness (µm) as evaluated by OCT (single measurement at study visit)

    Time frame: baseline V0

    in both groups (longterm treatment group ( ≥20 intravitreal injections) and shortterm treatment group (<5 intravitreal injections).

  2. 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)

    Time frame: baseline V0

    in both groups (longterm treatment group ( ≥20 intravitreal injections) and shortterm treatment group (<5 intravitreal injections).

  3. weight

    Time frame: baseline V0

    weight meassurements in kg

  4. height

    Time frame: baseline V0

    height meassurements in cm

Sponsors and collaborators

Lead sponsor

Dr. med. Katja Hatz

Other

Collaborators

  • Cenaug Foundation

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 7, 2019
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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