Home Monitoring in eAMD Treatment

NCT07340372 | Not Yet Recruiting

• 1 other identifier: 4C-2024-15
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Exudative Age-Related Macular Degeneration

Keywords

Aflibercept 8 mg; Exudative Age-Related Macular Degeneration; Patient reported outcomes; Value-based Healthcare; Home monitoring app

Outcome Measures

Primary Outcomes (2)

• Average change in best corrected visual acuity (BCVA) from baseline to month 12.

  BCVA will be assessed on both eyes, using best correction determined from protocol refraction. Measurements will be taken in a sitting position using ETDRS-like visual acuity testing charts at a starting distance of 4 meters.

  From baseline and then at each of the subsequent visits until month 12.

• Average change in BCVA from baseline to month 24.

  BCVA will be assessed on both eyes, using best correction determined from protocol refraction. Measurements will be taken in a sitting position using ETDRS-like visual acuity testing charts at a starting distance of 4 meters.

  From baseline and then at each of the subsequent visits until month 24.

Secondary Outcomes (29)

• Proportion of patients gaining ≥5, ≥10, ≥15 letters in BCVA at month 12.

  From baseline through month 12.

• Proportion of patients gaining ≥5, ≥10, ≥15 letters in BCVA at month 24.

  From baseline through month 24.

• Proportion of patients with BCVA ≥69 letters at month 12.

  From baseline through month 12.

• Proportion of patients with BCVA ≥69 letters at month 24.

  From baseline through month 24.

• Average change in central retinal thickness (CRT) from baseline to month 12.

  From baseline to month 12.

Interventions

Aflibercept 8mg DRUG

Patients will be treated with Aflibercept 8 mg, according to the standard clinical practice, in a treat and extent regimen with the inclusion of a home monitoring application.

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Adults (≥ 55 years old) with exudative AMD in the study eye.
• 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.
• Treatment with ocriplasmin (JETREA®) in the study eye at any time.

Sponsors & Collaborators

• Association for Innovation and Biomedical Research on Light and Image: lead

Study Sites (8)

Espaço Médico de Coimbra, Lda.

Coimbra, Portugal

Location

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

Coimbra, Portugal

Location

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

Leiria, Portugal

Location

Instituto Português de Microcirurgia Ocular, Lda.

Lisbon, Portugal

Location

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

Lisbon, Portugal

Location

Unidade Local de Saúde Loures-Odivelas

Loures, Portugal

Location

Unidade Local de Saúde de Santo António, E.P.E.

Porto, Portugal

Location

Unidade Local de Saúde de São João, E.P.E.

Porto, Portugal

Location

MeSH Terms

Interventions

aflibercept

Central Study Contacts

Joana F Tavares, PhD

CONTACT

+351 239 480137; home@aibili.pt

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 14, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

PT (8)