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

NCT ID: NCT05678517

Last Updated: 2023-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-01

Study Completion Date

2022-12-06

Brief Summary

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

Detailed Description

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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.

Conditions

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Age-Related Macular Degeneration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients

Patients with AMD

Anti-VEGF

Intervention Type DRUG

intravitreal ranibizumab or intravitreal aflibercept

Interventions

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Anti-VEGF

intravitreal ranibizumab or intravitreal aflibercept

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Semmelweis University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Papp AndrĂ¡s

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andras Papp, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Semmelweis University

Locations

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Department of Ophthalmology, Semmelweis University

Budapest, , Hungary

Site Status

Department of Ophthalmology, Bajcsy-Zsilinszky Hospital

Budapest, , Hungary

Site Status

Countries

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Hungary

References

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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.

Reference Type DERIVED
PMID: 36932356 (View on PubMed)

Other Identifiers

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SE RKB 168/2022

Identifier Type: -

Identifier Source: org_study_id

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