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).

Official title

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

Overview

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.

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.

Interventions

• Drug treatment with Aflibercept 8mg (Eylea)
  intravitreal injection of 8mg aflibercept

Primary outcome measures

• 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.]

Secondary outcome measures (3)

• Proportion of patients without disease activity at month 2 after treatment start [Time frame: 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 [Time frame: 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 [Time frame: Each participant is followed up for 2 months after their treatment with aflibercept 8mg.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Switzerland · 1 center

• Dept. of Ophthalmology, University Hospital, Inselspital — Bern

Identifiers

NCT: NCT07434713 · BASCEC Number: 2025-00103

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗