Early response to Eylea 8 mg in neovascular (wet) age-related macular degeneration

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

This observational project will try Eylea (aflibercept) 8 mg eye injections to see how retinal fluid and vision change over the first two months in people with active neovascular AMD.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Insel Gruppe AG, University Hospital Bern (Academic / other)
• Drugs / interventions: bevacizumab
• Locations: 1 site (Bern)
• Trial ID: NCT07434713 on ClinicalTrials.gov

What this trial studies

This is a prospective, observational, open-label study of intravitreal aflibercept 8 mg given to patients with exudative (neovascular) age-related macular degeneration. Retinal fluid dynamics are monitored using macular optical coherence tomography (OCT) to quantify intraretinal fluid, subretinal fluid, and sub–retinal pigment epithelium fluid over the first two months. The study also tracks hyperreflective retinal foci (HRF), complete RPE and outer retinal atrophy (cRORA), and changes in best-corrected visual acuity measured with ETDRS-like charts. Early anatomical and visual responses are analyzed to explore whether they predict disease activity and treatment need over the first year.

Who should consider this trial

Good fit: Adults with active subfoveal choroidal neovascularization from wet AMD showing intraretinal and/or subretinal fluid, lesion fibrosis less than 50% and baseline visual acuity of 23 ETDRS letters (≈20/320) or better are ideal candidates.

Not a fit: Patients without active retinal fluid (dry AMD), with extensive lesion fibrosis, very poor baseline vision below the entry threshold, pregnant or nursing women, or those unable to attend serial clinic visits are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the findings could help doctors use early OCT and vision changes to predict which patients will need more or less frequent injections, enabling more personalized treatment and potentially better vision preservation.

How similar studies have performed: Aflibercept has demonstrated efficacy in many trials for neovascular AMD and early OCT fluid reduction commonly correlates with longer-term outcomes, though the specific 8 mg dosing and focused early fluid-dynamics analysis are less extensively studied.

Eligibility criteria

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.

Where this trial is running

Bern

• Dept. of Ophthalmology, University Hospital, Inselspital — Bern, Switzerland (Recruiting)

Study contacts

• Principal investigator: Florian M Heussen, Dr. med. — Dept. of Ophthalmology, University Hospital, Inselspital
• Study coordinator: Florian M Heussen, Dr. med.

Conditions Age-Related Macular Degeneration; neovascular macular degeneration; Aflibercept; Eylea