EarLy Treatment Response in nEoVascular Macular Degeneration With Eylea 8mg: ELEV8 A Prosp
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 ana
| Condition(s) | Age-Related Macular Degeneration (AMD) |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 e |
| Ages | 50 Years |
| Sex | All |
| Lead sponsor | Insel Gruppe AG, University Hospital Bern |
| Locations | Bern, Switzerland |
| Start date | 2025-07-14 |
| NCT ID | NCT07434713 |
| Official listing | https://clinicaltrials.gov/study/NCT07434713 |