Home monitoring app for people taking aflibercept 8 mg for wet macular degeneration
Observes people on aflibercept 8 mg for wet macular degeneration using a home app.
Plain-language title generated from the registry record
Registry title: Home Monitoring in eAMD Treatment
Key facts
- Where
- Coimbra, Leiria, Lisbon, Loures, and Porto, PortugalSee the 8 sites
Where in Portugal
- Espaço Médico de Coimbra, Lda.Coimbra, PortugalNo longer taking part
- Unidade Local de Saúde de Coimbra, E.P.E.Coimbra, PortugalNo longer taking part
- Unidade Local de Saúde de Leiria, E.P.E.Leiria, PortugalNo longer taking part
- Instituto Português de Microcirurgia Ocular, Lda.Lisbon, PortugalNo longer taking part
- Unidade Local de Saúde de Lisboa Ocidental - Hospital de Egas MonizLisbon, PortugalNo longer taking part
- Unidade Local de Saúde Loures-OdivelasLoures, PortugalNo longer taking part
- Unidade Local De Saude De Santo Antonio E.P.E.Porto, PortugalNo longer taking part
- Unidade Local de Saude de Sao Joao E.P.E.Porto, PortugalNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Association for Innovation and Biomedical Research on Light and Image
- Trial code
- NCT07340372
- Record updated
- 6 May 2026
- Original description
The goal of this observational clinical study is to collect more information about the efficacy of Aflibercept 8 mg injections in people with eAMD. The main questions it aims to answer are:Read full original descriptionShow less
Home Monitoring in eAMD Treatment
The goal of this observational clinical study is to collect more information about the efficacy of Aflibercept 8 mg injections in people with eAMD. The main questions it aims to answer are:
* To reassure patients and doctors with longer intervals using home monitoring app; * To assess patient reported outcomes (PROMs) and Value-based Healthcare.
Participants already taking Aflibercept 8 mg as part of their regular medical care for eAMD will undergo regular ophthalmological examination and use a home monitoring app, in a one year and a two-year treatment period.
Inclusion: Adults (≥ 55 years old) with exudative AMD in the study eye; Treatment-naïve patients or patients who have started treatment with IVT anti-VEGF (aflibercept 2 mg, aflibercept 8 mg, faricimab, ranibizumab, bevacizumab, brolucizumab, pegaptanib sodium) up to 48 weeks before inclusion; BCVA early treatment diabetic retinopathy study (ETDRS) letter score of 85 to 34 (approximate Snellen equivalent of 20/20 to 20/200) in the study eye with decreased vision determined to be primarily the result of eAMD; Willing and able to comply with clinic visits and study-related procedures; Provide informed consent signed by study participant or legally acceptable representative; Own a working smartphone or tablet compatible with the OKKO Health application; Be able to operate the application after training according to OKKO Health indications of use: be alert and mentally competent, has competent dexterity and has normal or corrected hearing to normal audio level.
Exclusion: Treatment with ocriplasmin (JETREA®) in the study eye at any time; Other ocular disease in the study eye that could prevent an accurate evaluation of treatment efficacy like, diabetic macular edema, posterior uveitis, corneal opacity, vein occlusion, macular dystrophy; IVT anti-VEGF or steroid implants (aflibercept, ranibizumab, bevacizumab, brolucizumab, pegaptanib sodium, triamcinolone, dexamethasone, fluocinolone) for more than 1 year before inclusion; Evidence of macular edema due to any cause other than eAMD in either eye.