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Smartphone app could help wet AMD patients space out eye injections

NCT ID NCT07340372

Disease control Sponsor: Association for Innovation and Biomedical Research on Light and Image Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a home monitoring app can help people with wet age-related macular degeneration (eAMD) safely extend the time between Aflibercept injections. About 80 adults already receiving this treatment will use the app and have regular eye exams over one to two years. The goal is to see if vision stays stable with longer treatment intervals and to measure patient satisfaction.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Aflibercept 8 mg injection
What this could lead to
If successful, this could show that home monitoring allows patients with wet AMD to safely extend time between eye injections, reducing clinic visits while maintaining vision.
What could go wrong
This is an observational study with only 80 participants, so results may not apply to everyone. The home monitoring app's accuracy and patient adherence are unproven in this setting.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with eAMD with a diagnosis or under treatment for a period ≤ 1year.

Ages

55 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

wet macular degeneration

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Exudative age-related macular degeneration

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Espaço Médico de Coimbra, Lda.

    Coimbra, Portugal

  • Instituto Português de Microcirurgia Ocular, Lda.

    Lisbon, Portugal

  • Unidade Local de Saúde Loures-Odivelas

    Loures, Portugal

  • Unidade Local de Saúde de Coimbra, E.P.E.

    Coimbra, Portugal

  • Unidade Local de Saúde de Leiria, E.P.E.

    Leiria, Portugal

  • Unidade Local de Saúde de Lisboa Ocidental - Hospital de Egas Moniz

    Lisbon, 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

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