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Completed

NCT Number: NCT05678517

Seven-year Outcomes Following Intensive Anti-VEGF Therapy in Wet AMD

The aim of this study was to assess long-term benefits of intensive aflibercept and ranibizumab anti-VEGF therapy in patients with exudative AMD.

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Ophthalmology, Bajcsy-Zsilinszky Hospital, Budapest, Hungary

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About this study

This study was conducted at two clinical sites in Budapest, Hungary after the "Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (VIEW 2)" phase-3 multicenter, prospective, randomized, double blind clinical trial (ClinicalTrials.gov ID: NCT00637377).

Patients were treated with intravitreal anti-VEGF injections between 2008 and 2017. During the first 2 years in the framework of the VIEW 2 study, participants were randomized per protocol to intravitreal aflibercept or ranibizumab treatment arms and received injections according to the VIEW 2 study protocol.

This study focused on long-term outcomes that happened after the VIEW 2 study. After finishing the VIEW 2 study, patients returned to daily routine medical care and were followed under regular clinical care in real-life conditions and were treated with predominantly ranibizumab anti-VEGF injections (participants received interventions as part of routine medical care). Treatment was administered as needed according to the judgement of the physician. Retreatment criteria were based on visual acuity, signs of activity on optical coherence tomography (OCT) or indirect slit lamp biomicroscopy. Results at the end of the follow-up (year 7) were retrospectively analyzed.

Who can participate

Healthy volunteers accepted: No

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

  • Same as the original VIEW2 study (NCT00637377)
  • Finished VIEW 2 study

Treatment and study plan

Anti-VEGF

Drug

intravitreal ranibizumab or intravitreal aflibercept

Primary outcomes

  1. BCVA

    Time frame: At the end of follow-up (year 7)

    Best-corrected visual acuity

  2. Geographic atrophy

    Time frame: At the end of follow-up (year 7)

    Change in size of geographic atrophy on fundus autofluorescence (FAF)

  3. Retinal fluid

    Time frame: At the end of follow-up (year 7)

    Presence or absence of intra- or subretinal fluid on spectral-domain optical coherence tomography (OCT)

Secondary outcomes

  1. Number of injections

    Time frame: Over the course of the follow-up (7 years)

    Number of intravitreal anti-VEGF injections given

  2. Adverse events

    Time frame: Over the course of the follow-up (7 years)

    Potential adverse events

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Registry information

Official study title

Seven-year Outcomes Following Intensive Anti-vascular Endothelial Growth Factor Therapy in Patients With Exudative Age-related Macular Degeneration

Important dates

Study start
2010
Primary completion
2017
Study completion
2022
First posted
Jan 10, 2023
Registry last updated
Jan 10, 2023

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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