Home Monitoring in eAMD Treatment
Starting soon
Conditions studied: Exudative Age-Related Macular Degeneration
In brief
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.
Key facts
- Study ID
- NCT07340372
- Run by
- Association for Innovation and Biomedical Research on Light and Image
- People needed
- 80
- Starts
- 2026-05-01
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-05-06
Who can join
Age: 55 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Evidence of macular edema due to any cause other than eAMD in either eye.
- 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.
- Treatment with ocriplasmin (JETREA®) in the study eye at any time.
Where it is running
- Espaço Médico de Coimbra, Lda. — Coimbra, Portugal
- Unidade Local de Saúde de Coimbra, E.P.E. — Coimbra, Portugal
- Unidade Local de Saúde de Leiria, E.P.E. — Leiria, Portugal
- Instituto Português de Microcirurgia Ocular, Lda. — Lisbon, Portugal
- Unidade Local de Saúde de Lisboa Ocidental - Hospital de Egas Moniz — Lisbon, Portugal
- Unidade Local de Saúde Loures-Odivelas — Loures, Portugal
- Unidade Local de Saúde de Santo António, E.P.E. — Porto, Portugal
- Unidade Local de Saúde de São João, E.P.E. — Porto, Portugal
Full record on ClinicalTrials.gov
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