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). (ELEV8)

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.

Study Overview

• Status: Recruiting
• Conditions: Age-Related Macular Degeneration (AMD)
• Intervention / Treatment: Drug: treatment with Aflibercept 8mg (Eylea)

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Florian M Heussen, Dr. med.; Phone Number: +41 (0)31 664 54 24; Email: florian.heussen@insel.ch
• Study Contact Backup: Name: Martin S Zinkernagel, Prof. Dr. Dr. med.; Phone Number: +41 (0)31 632 85 03; Email: martin.zinkernagel@insel.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • Dept. of Ophthalmology, University Hospital, Inselspital
    • Contact: Florian M Heussen, Dr. med.; Phone Number: +41 (0)31 664 54 24; Email: florian.heussen@insel.ch
    • Contact: Martin S Zinkernagel, Prof. Dr. Dr. med.; Phone Number: +41 (0)31 632 85 03; Email: martin.zinkernagel@insel.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

treatment naïve patients with diagnosis of wAMD with SRF

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
  • 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
all study participants	Drug: treatment with Aflibercept 8mg (Eylea); intravitreal injection of 8mg aflibercept

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Each participant is followed up for 2 months after their treatment initiation with aflibercept 8mg
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.	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
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.	Each participant is followed up for 2 months after their treatment with aflibercept 8mg.

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Investigators: Principal Investigator: Florian M Heussen, Dr. med., Dept. of Ophthalmology, University Hospital, Inselspital

Publications and helpful links

Helpful Links

• Homepage about the On going Research of the University Hospital of Ophthalmology Inselspital,

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2025
• Primary Completion (Estimated): March 27, 2026
• Study Completion (Estimated): March 27, 2026

Study Registration Dates

• First Submitted: February 6, 2026
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Eylea; Aflibercept; neovascular macular degeneration
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Degeneration; Macular Degeneration; Therapeutics; aflibercept
• Other Study ID Numbers: BASCEC Number: 2025-00103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No