Neovascular (Wet) Age-Related Macular Degeneration
Conditions
Keywords
neovascular age-related macular degeneration, Aflibercept
Brief summary
This study will investigate if switching patients who appear to be sub-optimal responders to the current standard of care treatment with Aflibercept 2mg to Aflibercept 8mg will prolong treatment intervals and maintain visual acuity.
Detailed description
Aflibercept 8 mg was recently approved by the European Medicines Agency (EMA) for the treatment of neovascular age-related macular degeneration (nAMD). The higher dosage promises prolongation of treatment intervals up to 16 weeks. Only limited clinical data is available on switching from so-called suboptimal or non-responders. A retrospective analysis showed that aflibercept in 3 mg or 4 mg doses can improve outcomes in patients who do not respond optimally to aflibercept 2 mg. It remains unclear whether switching to the above-mentioned and newly approved aflibercept 8 mg will prolong treatment intervals and stabilize visual acuity in patients who are not treatment-naive. The present study is a single-center observational study. The plan is to include 50 eyes from 50 patients who have previously received aflibercept 2 mg injections. Patients receive a routine 8 mg aflibercept injection in the eye clinic based on the existing treat-extend regimen. At each visit, a visual acuity test, optical coherence tomography (OCT) imaging, and a standard slit lamp examination with fundoscopy are performed. The injection interval is extended by two weeks. If the two-week extension leads to deterioration, the interval is shortened by two weeks. Patients are monitored in the study for 12 months.
Interventions
DRUGAflibercept
Intravitreal injection with high dose (8 mg) aflibercept
Sponsors
Vienna Institute for Research in Ocular Surgery
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 105 Years
Healthy volunteers
No
Inclusion criteria
* Patients, who received prior intravitreal anti-VEGF-treatment for nAMD with Aflibercept 2mg. A minimum of four injections of Aflibercept 2mg is required. Therefore 16-24 weeks prior treatment with anti-VEGF is required in line with an interval of 4-8 weeks. * Short treatment intervals of 4 or 8 weeks * nAMD * Age 21 or older * Written informed consent
Exclusion criteria
* Chronic treatment with Bevacizumab or Faricimab * Extensive macular fibrosis * Diabetic retinopathy * Other retinal pathologies (e.g. retinal vein occlusion) * Dense media opacities (cataract, corneal scars) * Vitreous hemorrhage * Ocular or periocular infections * Active intraocular inflammation * Hypersensitivity to the active substance or to any of the excipients * Prior Aflibercept 8mg treatment * Pregnancy (for women in reproductive age a pregnancy test will be performed)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of intravitreal injections | 12 months | Total number of intravitreal injections will be assessed over 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| corrected distance visual acuity (CDVA) | 12 months | CDVA will be determined using ETDRS-charts in a distance of 4 metres and differences will be compared over a timeframe of up to 12 months |
| Central retinal thickness (CRT) | 12 months | CRT will be assessed using optical coherence tomography (OCT) and will be compared up to 12 months |
| Intraretinal fluid (IRF) | 12 months | IRF will be assessed using optical coherence tomography (OCT) and compared during a timeframe up to 12 months |
Countries
Austria
Contacts
PRINCIPAL_INVESTIGATOROliver Findl, Prof. Dr.
Vienna Institute for Research in Ocular Surgery
Outcome results
None listed