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Age-Related Macular DegenerationNCT05678517

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

An observational study of Age-Related Macular Degeneration, run by Semmelweis University at 2 sites in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Age-Related Macular Degeneration
What is being tested?
Anti-VEGF
How many people
47 participants
Where
2 sitesHungary
Study dates
1 Jan 2010to 6 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

2 sites in 1 country.

Hungary2 sites

  • Department of Ophthalmology, Semmelweis University

    Budapest, 1085

  • Department of Ophthalmology, Bajcsy-Zsilinszky Hospital

    Budapest

Other trials in Hungary

About this study

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

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

Read the detailed description

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.

Being tested
Anti-VEGF
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anti-VEGFDrug

    intravitreal ranibizumab or intravitreal aflibercept

Study groups in NCT05678517
Study groupRoleWhat they receive
PatientsPatients with AMD
Receives: Drug: Anti-VEGF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BCVA

    Best-corrected visual acuity

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

  2. Geographic atrophy

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

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

  3. Retinal fluid

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

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

Secondary outcomes (2)

  1. Number of injections

    Number of intravitreal anti-VEGF injections given

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

  2. Adverse events

    Potential adverse events

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2023
  2. Study start1 Jan 2010
  3. Primary completion31 Dec 2017
  4. Study completion6 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05678517
Sponsor's protocol ID
SE RKB 168/2022
Status last verified
Dec 2022
First submitted
16 Dec 2022
Last updated
10 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36932356

Questions about this trial

What is this clinical trial studying?

An observational study of Age-Related Macular Degeneration, run by Semmelweis University at 2 sites in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BCVA (time frame: At the end of follow-up (year 7)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05678517, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.

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