NCT05678517

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
Last Updated

January 10, 2023

Status Verified

December 1, 2022

Enrollment Period

8 years

First QC Date

December 16, 2022

Last Update Submit

December 28, 2022

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (3)

  • BCVA

    Best-corrected visual acuity

    At the end of follow-up (year 7)

  • Geographic atrophy

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

    At the end of follow-up (year 7)

  • Retinal fluid

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

    At the end of follow-up (year 7)

Secondary Outcomes (2)

  • Number of injections

    Over the course of the follow-up (7 years)

  • Adverse events

    Over the course of the follow-up (7 years)

Study Arms (1)

Patients

Patients with AMD

Drug: Anti-VEGF

Interventions

Anti-VEGFDRUG

intravitreal ranibizumab or intravitreal aflibercept

Patients

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Same as the original VIEW2 study (NCT00637377) * Patients who finished the VIEW 2 study

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Department of Ophthalmology, Semmelweis University

Budapest, 1085, Hungary

Location

Department of Ophthalmology, Bajcsy-Zsilinszky Hospital

Budapest, Hungary

Location

Related Publications (1)

  • Lukacs R, Schneider M, Nagy ZZ, Sandor GL, Kaan K, Asztalos A, Enyedi L, Pek G, Barcsay G, Szabo A, Borbandy A, Kovacs I, Resch MD, Papp A. Seven-year outcomes following intensive anti-vascular endothelial growth factor therapy in patients with exudative age-related macular degeneration. BMC Ophthalmol. 2023 Mar 17;23(1):110. doi: 10.1186/s12886-023-02843-2.

    PMID: 36932356DERIVED

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Andras Papp, MD, PhD

    Semmelweis University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 16, 2022

First Posted

January 10, 2023

Study Start

January 1, 2010

Primary Completion

December 31, 2017

Study Completion

December 6, 2022

Last Updated

January 10, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

HU(2)