Neovascular (Wet) Age-Related Macular DegenerationNCT07390253
Switch From 2mg Aflibercept to 8mg Aflibercept in Patients With Neovascular Age-related Macular Degeneration
An observational study of Neovascular (Wet) Age-Related Macular Degeneration, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
This study will investigate if switching patients who appear to be sub-optimal responders to the current standard of care treatment with Aflibercept 2mg to Aflibercept 8mg will prolong treatment intervals and maintain visual acuity. Read more about this study
- Who is it for?
- Ages 21 to 105 years
- Conditions the study is for
- Neovascular (Wet) Age-Related Macular Degeneration
- What is being tested?
- Aflibercept
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 18 Sep 2024to 1 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 21 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with neovascular AMD, which are suboptimal responders to the current standard of care
Who may be able to join
- Patients, who received prior intravitreal anti-VEGF-treatment for nAMD with Aflibercept 2mg. A minimum of four injections of Aflibercept 2mg is required. Therefore 16-24 weeks prior treatment with anti-VEGF is required in line with an interval of 4-8 weeks.
- Short treatment intervals of 4 or 8 weeks
- nAMD
- Age 21 or older
- Written informed consent
Who cannot join
- Chronic treatment with Bevacizumab or Faricimab
- Extensive macular fibrosis
- Diabetic retinopathy
- Other retinal pathologies (e.g. retinal vein occlusion)
- Dense media opacities (cataract, corneal scars)
- Vitreous hemorrhage
Show all 11Show fewer
- Ocular or periocular infections
- Active intraocular inflammation
- Hypersensitivity to the active substance or to any of the excipients
- Prior Aflibercept 8mg treatment
- Pregnancy (for women in reproductive age a pregnancy test will be performed)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aflibercept 8mg in Patients Diagnosed With Neovascular Age-related Macular Degeneration (AMD) Who Have Been Treated With Aflibercept 2mg: the Eylea 8mg Switch Study
This study will investigate if switching patients who appear to be sub-optimal responders to the current standard of care treatment with Aflibercept 2mg to Aflibercept 8mg will prolong treatment intervals and maintain visual acuity.
Read the detailed description
Aflibercept 8 mg was recently approved by the European Medicines Agency (EMA) for the treatment of neovascular age-related macular degeneration (nAMD). The higher dosage promises prolongation of treatment intervals up to 16 weeks. Only limited clinical data is available on switching from so-called suboptimal or non-responders. A retrospective analysis showed that aflibercept in 3 mg or 4 mg doses can improve outcomes in patients who do not respond optimally to aflibercept 2 mg. It remains unclear whether switching to the above-mentioned and newly approved aflibercept 8 mg will prolong treatment intervals and stabilize visual acuity in patients who are not treatment-naive.
The present study is a single-center observational study. The plan is to include 50 eyes from 50 patients who have previously received aflibercept 2 mg injections. Patients receive a routine 8 mg aflibercept injection in the eye clinic based on the existing treat-extend regimen. At each visit, a visual acuity test, optical coherence tomography (OCT) imaging, and a standard slit lamp examination with fundoscopy are performed. The injection interval is extended by two weeks. If the two-week extension leads to deterioration, the interval is shortened by two weeks. Patients are monitored in the study for 12 months.
- Being tested
- Aflibercept
- Keywords
- neovascular age-related macular degeneration, Aflibercept
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfliberceptDrug
Intravitreal injection with high dose (8 mg) aflibercept
| Study group | Role | What they receive |
|---|---|---|
| neovascular age-related macular degeneration (nAMD) | Patient suffering from neovascular age-related macular degeneration (nAMD) Receives: Drug: Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of intravitreal injections
Total number of intravitreal injections will be assessed over 12 months
Measured: 12 months
Secondary outcomes (3)
corrected distance visual acuity (CDVA)
CDVA will be determined using ETDRS-charts in a distance of 4 metres and differences will be compared over a timeframe of up to 12 months
Measured: 12 months
Central retinal thickness (CRT)
CRT will be assessed using optical coherence tomography (OCT) and will be compared up to 12 months
Measured: 12 months
Intraretinal fluid (IRF)
IRF will be assessed using optical coherence tomography (OCT) and compared during a timeframe up to 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start18 Sep 2024
- Primary completion1 Feb 2026
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neovascular (Wet) Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vienna Institute for Research in Ocular Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
- Investigators
- Oliver Findl, Prof. Dr., Principal investigator, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390253
- Sponsor's protocol ID
- High Dose (HD) Eylea
- Status last verified
- Feb 2026
- First submitted
- 28 Jan 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Spartalis C, Ullrich M, Winkler S, Leisser C, Ruiss M, Pilwachs C, Findl O. Prospective Real-World Outcomes After Switching to Aflibercept 8 mg in Neovascular Age-Related Macular Degeneration with High Treatment Burden. Ophthalmol Ther. 2026 Jul;15(7):2285-2303. doi: 10.1007/s40123-026-01394-1. Epub 2026 May 19.
PubMed 42154394
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aflibercept 8mg in Patients Diagnosed With Neovascular Age-related Macular Degeneration (AMD) Who Have Been Treated With Aflibercept 2mg: the Eylea 8mg Switch Study
- ClinicalTrials.gov ID
- NCT07390253
- Acronym / sponsor ID
- High Dose (HD) Eylea
- Keywords
- neovascular age-related macular degeneration, Aflibercept
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- 18 Sep 2024 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate if switching patients who appear to be sub-optimal responders to the current standard of care treatment with Aflibercept 2mg to Aflibercept 8mg will prolong treatment intervals and maintain visual acuity.
Detailed description
Aflibercept 8 mg was recently approved by the European Medicines Agency (EMA) for the treatment of neovascular age-related macular degeneration (nAMD). The higher dosage promises prolongation of treatment intervals up to 16 weeks. Only limited clinical data is available on switching from so-called suboptimal or non-responders. A retrospective analysis showed that aflibercept in 3 mg or 4 mg doses can improve outcomes in patients who do not respond optimally to aflibercept 2 mg. It remains unclear whether switching to the above-mentioned and newly approved aflibercept 8 mg will prolong treatment intervals and stabilize visual acuity in patients who are not treatment-naive.
The present study is a single-center observational study. The plan is to include 50 eyes from 50 patients who have previously received aflibercept 2 mg injections. Patients receive a routine 8 mg aflibercept injection in the eye clinic based on the existing treat-extend regimen. At each visit, a visual acuity test, optical coherence tomography (OCT) imaging, and a standard slit lamp examination with fundoscopy are performed. The injection interval is extended by two weeks. If the two-week extension leads to deterioration, the interval is shortened by two weeks. Patients are monitored in the study for 12 months.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neovascular age-related macular degeneration (nAMD) | – | Drug: AfliberceptPatient suffering from neovascular age-related macular degeneration (nAMD) |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with neovascular AMD, which are suboptimal responders to the current standard of care
Key inclusion criteria (5 listed)
- Patients, who received prior intravitreal anti-VEGF-treatment for nAMD with Aflibercept 2mg. A minimum of four injections of Aflibercept 2mg is required. Therefore 16-24 weeks prior treatment with anti-VEGF is required in line with an interval of 4-8 weeks.
- Short treatment intervals of 4 or 8 weeks
- nAMD
- Age 21 or older
- Written informed consent
Key exclusion criteria (11 listed)
- Chronic treatment with Bevacizumab or Faricimab
- Extensive macular fibrosis
- Diabetic retinopathy
- Other retinal pathologies (e.g. retinal vein occlusion)
- Dense media opacities (cataract, corneal scars)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AfliberceptIntravitreal injection with high dose (8 mg) aflibercept | Drug | neovascular age-related macular degeneration (nAMD) |
Primary outcome
Number of intravitreal injections
Time frame: 12 months
Total number of intravitreal injections will be assessed over 12 months
3 secondary outcomes
corrected distance visual acuity (CDVA)
Time frame: 12 months
Central retinal thickness (CRT)
Time frame: 12 months
Intraretinal fluid (IRF)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Derived from this study: PubMed 42154394Spartalis C, Ullrich M, Winkler S, Leisser C, Ruiss M, Pilwachs C, Findl O. Prospective Real-World Outcomes After Switching to Aflibercept 8 mg in Neovascular Age-Related Macular Degeneration with High Treatment Burden. Ophthalmol Ther. 2026 Jul;15(7):2285-2303. doi: 10.1007/s40123-026-01394-1. Epub 2026 May 19.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Findl, Prof. Dr. principal investigator
Vienna Institute for Research in Ocular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neovascular (Wet) Age-Related Macular Degeneration, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of intravitreal injections (time frame: 12 months). 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 NCT07390253, 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 17 Feb 2026.