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NCT07340372Not yet recruiting

Home Monitoring in eAMD Treatment

Source: ClinicalTrials.gov · Last updated 6 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
80 (estimated)
First submitted
6 Jan 2026
Start date
1 May 2026
Primary completion date
31 Dec 2027
Lead sponsor
Association for Innovation and Biomedical Research on Light and Image
NCT number
NCT07340372

What you commit to

  • Study type: Observational
  • Planned participants: 80
  • From 1 May 2026 to the primary completion date, 31 Dec 2027
  • 8 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Treatment with ocriplasmin (JETREA®) in the study eye at any time.

Other illness

  • 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.

Lab values

  • IVT anti-VEGF or steroid implants (aflibercept, ranibizumab, bevacizumab, brolucizumab, pegaptanib sodium, triamcinolone, dexamethasone, fluocinolone) for more than 1 year before inclusion.

Other

  • Evidence of macular edema due to any cause other than eAMD in either eye.

Who the study is looking for

  • 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.

Age in the registry: 55 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Espaço Médico de Coimbra, Lda.
Coordinator of this site? Confirm its status
CoimbraPortugalUnknown status
Unidade Local de Saúde de Coimbra, E.P.E.
Coordinator of this site? Confirm its status
CoimbraPortugalUnknown status
Unidade Local de Saúde de Leiria, E.P.E.
Coordinator of this site? Confirm its status
LeiriaPortugalUnknown status
Unidade Local de Saúde de Lisboa Ocidental - Hospital de Egas Moniz
Coordinator of this site? Confirm its status
LisbonPortugalUnknown status
Instituto Português de Microcirurgia Ocular, Lda.
Coordinator of this site? Confirm its status
LisbonPortugalUnknown status
Unidade Local de Saúde Loures-Odivelas
Coordinator of this site? Confirm its status
LouresPortugalUnknown status
Unidade Local de Saude de Sao Joao E.P.E.
Coordinator of this site? Confirm its status
PortoPortugalUnknown status
Unidade Local De Saude De Santo Antonio E.P.E.
Coordinator of this site? Confirm its status
PortoPortugalUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.