Actively Recruiting
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).
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2026-02-27
50
Participants Needed
1
Research Sites
36 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of subfoveal choroidal neovascularization secondary to wet age-related macular degeneration (wAMD) without restriction on lesion size
- Active wAMD lesions with evidence of subretinal fluid and/or intraretinal fluid
- Fibrosis area less than 50% of lesion area
- Best-corrected visual acuity (BCVA) scores of 23 letters or more on ETDRS-like charts (approximate Snellen equivalent 20/320 or better) at screening and baseline
- Only one eye to be treated; if both eligible, the eye with lower visual acuity or chosen by investigator if equal
You will not qualify if you...
- Inability to comply with study or follow-up procedures
- Pregnant or nursing women
- Women of child-bearing potential not using or unwilling to use reliable contraception during study
- Systemic disease or treatment that may bias clinical assessment or increase risk, per investigator
- Stroke or heart attack within 3 months before consent
- Uncontrolled blood pressure (systolic >160 mmHg or diastolic >100 mmHg) at screening or baseline
- Known allergy to aflibercept 8mg or its components
- Prior or current use of systemic anti-VEGF drugs
- Use of systemic medications toxic to lens, retina, or optic nerve (e.g., chloroquine, deferoxamine, tamoxifen) currently or planned
- Use of systemic or intravitreal corticosteroids for at least 30 consecutive days within 3 months before consent
- Use of other investigational drugs within 6 months before consent
- Previous screen failure in this study
- Active eye infection or inflammation at screening or baseline
- Uncontrolled glaucoma (intraocular pressure ≥30 mmHg) at screening or baseline
- Neovascularization of iris or neovascular glaucoma at screening or baseline
- Inability to obtain quality SD-OCT images
- Intraocular surgery within 2 months before consent or expected within 6 months after consent
- Significant cataract, aphakia, pseudoexfoliation, retinal detachment, diabetic retinopathy, or CNV from other causes at screening or baseline
- Structural damage in central macula preventing vision improvement
- Subretinal hemorrhage involving central foveal field ≥1 disc diameter
- Prior intraocular anti-VEGF, corticosteroid treatment, photodynamic therapy, or retinal laser before consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Dept. of Ophthalmology, University Hospital, Inselspital
Bern, Switzerland, 3010
Actively Recruiting
Research Team
F
Florian M Heussen, Dr. med.
CONTACT
M
Martin S Zinkernagel, Prof. Dr. Dr. med.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here