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).

NCT07434713 | Recruiting FDA Drug

• 1 other identifier: BASCEC Number: 2025-00103
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Age-Related Macular Degeneration (AMD)

Keywords

neovascular macular degeneration; Aflibercept; Eylea

Outcome Measures

Primary Outcomes (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).

  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)

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

  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

  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

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

Study Arms (1)

all study participants

Drug: treatment with Aflibercept 8mg (Eylea)

Interventions

treatment with Aflibercept 8mg (Eylea) DRUG

intravitreal injection of 8mg aflibercept

all study participants

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

treatment naïve patients with diagnosis of wAMD with SRF

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Dept. of Ophthalmology, University Hospital, Inselspital

Bern, 3010, Switzerland

RECRUITING

Related Links

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

MeSH Terms

Conditions

Macular Degeneration

Interventions

Therapeutics; aflibercept

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Florian M Heussen, Dr. med.

  Dept. of Ophthalmology, University Hospital, Inselspital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 27, 2026
• Study Start: July 14, 2025
• Primary Completion: March 27, 2026
• Study Completion: March 27, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

CH (1)