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Age-Related Macular Degeneration (AMD)ELEV8NCT07434713

EarLy Treatment Response in nEoVascular Macular Degeneration With Eylea 8mg: ELEV8 A Prospective Observational Open Label Study Investigating the Fluid Dynamics During Early Response to Aflibercept 8mg in Patients With Exudative Age-related Macular Degeneration (AMD).

An observational study of Age-Related Macular Degeneration (AMD), run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This prospective, observational, open-label study evaluates early treatment response to intravitreal aflibercept 8 mg in patients with exudative age-related macular degeneration. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Age-Related Macular Degeneration (AMD)
What is being tested?
treatment with Aflibercept 8mg (Eylea)
Type of treatment
Injection or infusion
How many people
50 participants
Where
1 siteSwitzerland
Study dates
14 Jul 2025to 27 Mar 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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: treatment naïve patients with diagnosis of wAMD with SRF

Who may be able to join

  • Diagnosis of subfoveal CNV secondary to wAMD without restriction of lesion size. Active wAMD lesions are characterised by the following:
  • Evidence of SRF and/or IRF and
  • area of fibrosis less than 50% of the lesion area. BCVA scores at both screening and baseline must be 23 letters or more as measured by the ETDRS-like charts (or approximate Snellen equivalent to 20/320).
  • Only one eye (the study eye) will be treated with study drug. If both eyes are eligible at screening and baseline, the eye with the lower VA will be defined as the study eye. If both eyes are eligible and VA is the same for both eyes, the Investigator will chose the study eye based on clinical judgment.

Who cannot join

  • The presence of any one of the following exclusion criteria will lead to exclusion of the participant:
  • Inability to comply with study or follow-up procedures.
  • Pregnant or nursing (lactating) women.
  • Women of child-bearing potential, not using or not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the Investigator in individual cases. (Female participants who are surgically sterilised/hysterectomised, or post-menopausal for longer than 2 years are not considered as being of child-bearing potential.)
  • Any type of systemic disease or its treatment, in the opinion of the Investigator, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk.
  • Stroke or myocardial infarction less than 3 months prior to the date of informed consent signature.
Show all 24Show fewer
  • Uncontrolled blood pressure defined as systolic value of >160 mmHg or diastolic value of >100 mmHg at screening or baseline.
  • Known hypersensitivity to aflibercept 8mg or any component of the aflibercept formulation.
  • Prior or current use of any systemic anti-VEGF drugs [e.g., bevacizumab (Avastin®)]
  • Current or planned use of systemic medications known to be toxic to the lens, retina or optic nerve, including chloroquine/hydroxychloroquine (Plaquenil®), deferoxamine, phenothiazines, tamoxifen, and ethambutol.
  • Use of systemic or intravitreal corticosteroids for at least 30 consecutive days within 3 months prior to the date of informed consent signature.
  • Use of other investigational drugs within 6 months prior to the date of informed consent signature.
  • Patient was previously screened for participation in the study and was a screen failure.
  • Exclusion criteria for ocular medical history and conditions:
  • Study eye:
  • Active periocular or ocular infection or inflammation (e.g., blepharitis, conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) at screening or baseline.
  • Uncontrolled glaucoma (intraocular pressure ≥30 mmHg under treatment or as assessed by the investigator) at screening or baseline.
  • Neovascularization of the iris or neovascular glaucoma at screening or baseline.
  • Inability to obtain SD-OCT images of sufficient quality for analysis.
  • Intraocular surgery (including Yttrium-Aluminum-Garnet capsulotomy) within two months before the date of consent or expected within the next six months after the date of consent.
  • Visually significant cataract, aphakia, pseudoexfoliation, translucent hemorrhage, retinal detachment, diabetic retinopathy, or CNV from a cause other than wAMD at screening or baseline.
  • Structural damage within the central macula in an area of 0.5 disc diameter at screening or baseline that, in the opinion of the investigator, precludes improvement in visual acuity.
  • Subretinal hemorrhage involving the central foveal field with a size of ≥1 disc diameter at screening or baseline.
  • Any prior intraocular treatment with an anti-VEGF medication or intravitreal corticosteroids, or prior treatment with photodynamic therapy (PDT) or other retinal laser treatments before the date of consent.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Florian M Heussen, Dr. med. contact

+41 (0)31 664 54 24

florian.heussen@insel.ch

Martin S Zinkernagel, Prof. Dr. Dr. med. contact

+41 (0)31 632 85 03

martin.zinkernagel@insel.ch

Switzerland1 site, 1 recruiting

  • Dept. of Ophthalmology, University Hospital, Inselspital

    Bern, 3010

    Martin S Zinkernagel, Prof. Dr. Dr. med., +41 (0)31 632 85 03, martin.zinkernagel@insel.ch

    Florian M Heussen, Dr. med., +41 (0)31 664 54 24, florian.heussen@insel.ch

    Recruiting

Other trials in Switzerland

About this study

Official title: EarLy Treatment Response in nEoVascular Macular Degeneration With Eylea 8mg: ELEV8

This prospective, observational, open-label study evaluates early treatment response to intravitreal aflibercept 8 mg in patients with exudative age-related macular degeneration. Retinal fluid dynamics assessed by optical coherence tomography and changes in best-corrected visual acuity two months after baseline are analyzed to characterize early treatment outcomes.

Read the detailed description

This prospective, observational, open-label study investigates early anatomical and functional responses to intravitreal aflibercept 8 mg in patients with exudative age-related macular degeneration (AMD). The primary focus is on retinal fluid dynamics during the initial treatment phase, assessed by macular optical coherence tomography (OCT).

Changes in intraretinal fluid, subretinal fluid, and sub-retinal pigment epithelium (sub-RPE) fluid levels are evaluated over the first two months of treatment. In addition, the frequency of detection of hyperreflective retinal foci (HRF) and complete retinal pigment epithelium and outer retinal atrophy (cRORA) on OCT scans is assessed during this period.

Functional outcomes are evaluated by changes in best-corrected visual acuity (BCVA), measured using ETDRS charts, two months after baseline. Furthermore, the proportion of patients without signs of disease activity at two months is determined. Early anatomical and functional responses observed during the first two months are analyzed to explore their potential value in predicting treatment demand over the first year of therapy.

Being tested
treatment with Aflibercept 8mg (Eylea)
Keywords
neovascular macular degeneration, Aflibercept, Eylea
Medical subject headings
Macular Degeneration

What participants receive

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

  • treatment with Aflibercept 8mg (Eylea)Drug

    intravitreal injection of 8mg aflibercept

Study groups in NCT07434713
Study groupRoleWhat they receive
all study participantsNot described
Receives: Drug: treatment with Aflibercept 8mg (Eylea)

What is being measured

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

  1. Fluid dynamics on OCT scans during the early treatment phase of macular degeneration with Aflibercept 8mg.

    Change in fluid levels of intraretinal fluid (IRF), subretinale fluid (SRF) and sub retinal pigment epithelium fluid (subRPE fluid) will be analyzed using an AI based software tool on macular OCT-scans during the first two months of treatment with aflibercept 8mg. Fluid volumes will be quantified for each available OCT scan and represented as Nanoliters (nL). The analysis will return quantitative values for the OCT scan as a whole and also for each subfield of the ETDRS-Grid (Early-Treatment-Diabetic-Retinopathy-Study).

    Measured: Each participant is followed up for 2 months after their treatment with aflibercept 8mg. From study enrollment and the 1st injection, over weekly check ups until the 2nd injection, completed with a last visit and the 3rd and last injection.

Secondary outcomes (3)

  1. Proportion of patients without disease activity at month 2 after treatment start

    At the final study visit, two months after treatment initiation, disease activity is assessed. Patients are considered disease-free if they show no intraretinal fluid (IRF) or no subretinal fluid (SRF) on OCT imaging.

    Measured: Each participant is followed up for 2 months after their treatment initiation with aflibercept 8mg

  2. Prediction of Annual Treatment Demand in nAMD Patients at 12 Months

    The annual treatment demand is defined as the total number of intravitreal injections administered to patients with neovascular age-related macular degeneration (nAMD) within the first 12 months following the initial injection. To predict this demand early in the treatment course, a predictive model is being developed based on early OCT features and clinical parameters obtained at baseline and during the initial treatment phase. As the 12-month endpoint extends beyond the primary study period, this outcome requires additional follow-up data outside the core study timeframe. This extended follow-up does not necessitate additional study visits, as the information is obtained from routine clinical records.

    Measured: Each participant is followed up for two months within the study protocol. For the prediction of annual treatment demand, additional data on the total number of injections up to 12 months after the initial injection are required, without extra study visit

  3. Best-Corrected Visual Acuity (BCVA) Outcomes at Two Months Post-Treatment

    Best-corrected visual acuity (BCVA) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) charts and recorded as the total number of letters read correctly. Measurements were taken at baseline, at multiple timepoints throughout the study, and at the final visit two months after treatment initiation. The change in BCVA from baseline to the final visit was then evaluated to determine whether visual acuity had improved.

    Measured: Each participant is followed up for 2 months after their treatment with aflibercept 8mg.

Timeline

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

  1. First posted27 Feb 2026
  2. Study start14 Jul 2025
  3. Primary completion27 Mar 2026 (estimated)
  4. Study completion27 Mar 2026 (estimated)

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
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07434713
Sponsor's protocol ID
BASCEC Number: 2025-00103
Acronym
ELEV8
Status last verified
Feb 2026
First submitted
6 Feb 2026
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Age-Related Macular Degeneration (AMD), run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

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 4 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 27 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 Switzerland. 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?

Contact Florian M Heussen, Dr. med. (+41 (0)31 664 54 24, florian.heussen@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fluid dynamics on OCT scans during the early treatment phase of macular degeneration with Aflibercept 8mg. (time frame: Each participant is followed up for 2 months after their treatment with aflibercept 8mg. From study enrollment and the 1st injection, over weekly check ups until the 2nd injection, completed with a last visit and the 3rd and last injection.). 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 NCT07434713.

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 27 Feb 2026.

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