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Completed

NCT Number: NCT04138420

Evaluation of Retinal and Vascular Features in Macular Degeneration After Intravitreal Injections of Bevacizumab

This study evaluates the retinal and vascular features in patients with macular degeneration under the effects of Bevacizumab intravitreal injections using optical coherence tomography and optical coherence tomography angiography.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Naples "Federico II"

Naples, 80100, Italy

About this study

Bevacizumab is a vascular endothelial growth factor antagonist represent an efficacy treatment for exudative age-related macular degeneration acting on vascular hyperpermeability.

The optical coherence tomography and optical coherence tomography angiography represent novel and non-invasive diagnostic techniques that allow a detailed and quantitative analysis of retinal and vascular features.

The study evaluates the changes in optical coherence tomography and optical coherence tomography angiography parameters at baseline and after three monthly injections of Bevacizumab in exudative AMD.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age older than 50 years, diagnosis of exudative age-related macular degeneration, treatment-naïve with Bevacizumab for exudative age-related macular degeneration.

Exclusion criteria

  • age younger than 50 years, diagnosis of exudative macular degeneration due to other causes, previous treatments before Bevacizumab for exudative age-related macular degeneration.

Treatment and study plan

Bevacizumab Injection

Drug

Three monthly intravitreal injections of bevacizumab (1.25 mg/0.05 mL)

Other names: Avastin

Primary outcomes

  1. Study of retinal structural features in exudative age-related macular degeneration after intravitreal injections of Bevacizumab

    Time frame: three months

    The effectiveness of Bevacizumab injections for treating exudative age-related macular degeneration using optical coherence tomography. The parameters analyzed by optical coherence tomography: Central Macular Thickness and Subfoveal Choroidal thickness (microns).

  2. Study of retinal vascular features in exudative age-related macular degeneration after intravitreal injections of Bevacizumab

    Time frame: three months

    The effectiveness of Bevacizumab injections for treating exudative age-related macular degeneration using optical coherence tomography angiography. The parameters analyzed by optical coherence tomography angiography were: retinal and choriocapillaris vessel density (%).

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

Study of Retinal and Vascular Features by Optical Coherence Tomography and Optical Coherence Tomography Angiography After Intravitreal Injections of Bevacizumab in Exudative Age-related Macular Degeneration

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 24, 2019
Registry last updated
Oct 24, 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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