Actively Recruiting
Early Treatment Response in Neovascular Macular Degeneration Using Aflibercept 8mg: A Prospective Observational Study
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2026-02-27
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate early treatment responses in patients aged 50 and older with exudative age-related macular degeneration (AMD). It focuses on observing retinal fluid changes and visual acuity improvements after treatment with intravitreal aflibercept 8 mg, an anti-VEGF drug, during the initial two months. The study also explores how early treatment outcomes may help predict future treatment needs over a year. Participants receive intravitreal injections of aflibercept 8 mg and undergo weekly check-ups from the first injection until the second, followed by a final visit and a third injection. These visits include retinal imaging using optical coherence tomography (OCT) to assess fluid levels in various retinal layers and monitoring of disease activity. The study is observational and open-label, meaning all participants receive the treatment and are monitored closely without a placebo group. During the two-month study period, researchers measure changes in retinal fluid, detection of specific retinal features, and best-corrected visual acuity using ETDRS charts. Patients are followed from initial treatment through weekly assessments to evaluate anatomical and functional responses. Data on treatment demand up to 12 months are also collected without additional study visits. The study aims to provide detailed insight into early treatment effects and their potential to guide longer-term therapy.
CONDITIONS
Brief 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
- Active lesions with evidence of subretinal and/or intraretinal fluid
- Lesion fibrosis area less than 50% of total lesion area
- Best-corrected visual acuity of 23 letters or more on ETDRS charts (or approximate Snellen equivalent 20/320) at screening and baseline
- Only one eye treated; if both eligible, the eye with lower visual acuity or as chosen by investigator
- Able to comply with study procedures and follow-up visits
You will not qualify if you...
- Inability to comply with study or follow-up procedures
- Pregnant or nursing women
- Women of childbearing potential not using reliable contraception during the study
- Systemic diseases or treatments that may bias clinical assessments or pose risk
- Stroke or heart attack within 3 months before consent
- Uncontrolled high blood pressure (systolic >160 mmHg or diastolic >100 mmHg)
- Known allergy to aflibercept or its components
- Prior or current use of systemic anti-VEGF drugs
- Use of systemic medications toxic to eye structures
- Use of corticosteroids for at least 30 consecutive days within 3 months before consent
- Use of investigational drugs within 6 months before consent
- Previous screen failure for this study
- Active eye infections or inflammation in the study eye
- Uncontrolled glaucoma or neovascular glaucoma
- Inability to obtain quality OCT images
- Recent or planned intraocular surgery within specific timeframes
- Other significant ocular conditions affecting vision or structural damage precluding visual improvement
- Prior intraocular anti-VEGF, corticosteroid, photodynamic therapy, or retinal laser treatments before consent
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 months
Participants receive intravitreal injections of aflibercept 8mg to treat neovascular macular degeneration. Early anatomical and functional responses are monitored during this phase.
Weekly visits for up to 8 weeks including 3 injections
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.
M
Martin S Zinkernagel, Prof. Dr. Dr. med.
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
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