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OpenTrials
Completed

NCT Number: NCT03680326

Intravitreal Anti-vascular Endothelial Growth Factor Administration and Its Influence on Vitreomacular Interface- and Retinal Morphology in Eyes With Neovascular Age-related Macular Degeneration

Purpose:

To assess the influence of intravitreal anti-vascular endothelial growth factor (anti-VEGF) administration on vitreomacular interface- and retinal morphology in eyes with neovascular age-related macular degeneration (AMD) and to identify morphological markers potentially influencing disease prognosis.

Methods:

43 patients (51 eyes) with treatment naïve neovascular AMD subsequently treated with Bevacizumab 1.25mg (in 0.05ml of solution) were monitored until month 12 of follow-up. Following a loading dose of 3 monthly intravitreal anti-VEGF injections, patients were treated as-needed [pro re nata (PRN)]. Functional and morphological changes were assessed using Spectral Domain Optical Coherence Tomography (SD-OCT).

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Key information

Age range

66 year–98 year

Sex eligibility

All sexes

Study type

Observational

About this study

This retrospective study included 43 treatment-naive patients (51 eyes) with neovascular AMD over the course of 12 months. Patients were treated with a loading dose of 3 initial monthly anti-VEGF injections (Bevacizumab 1.25mg in 0.05ml of solution-Avastin®) and were followed monthly until year 1. Re-treatment was performed if needed (pro re nata-PRN) as previously reported.

Who can participate

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

Inclusion criteria

  • diagnosis of treatment-naive neovascular AMD

Exclusion criteria

  • any treatment with other anti-VEGF agents than Bevacizumab in the follow-up period
  • any other diseases leading to macular edema
  • prior vitrectomy
  • uveitis
  • retinal or corneal laser surgery
  • high myopia (>6dpt)
  • preceding eye trauma

Treatment and study plan

OCT

Device

only OCT

Primary outcomes

  1. visual acuity

    Time frame: 12 months

    visual acuity testing was performed

Sponsors and collaborators

Lead sponsor

Hospital Hietzing

Other

Registry information

Official study title

Influence of Intravitreal Anti-vascular Endothelial Growth Factor Administration on Vitreomacular Interface- and Retinal Morphology in Eyes With Neovascular Age-related Macular Degeneration

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 21, 2018
Registry last updated
Sep 21, 2018

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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