Exudative Age-Related Macular DegenerationHOMENCT07340372
Home Monitoring in eAMD Treatment
An observational study of Exudative Age-Related Macular Degeneration, run by Association for Innovation and Biomedical Research on Light and Image at 8 sites in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Exudative Age-Related Macular Degeneration
- What is being tested?
- Aflibercept 8mg
- How many people
- 80 participants
- Where
- 8 sitesPortugal
- Study dates
- May 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with eAMD with a diagnosis or under treatment for a period ≤ 1year.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Portugal8 sites
Espaço Médico de Coimbra, Lda.
Coimbra
João Figueira
Unidade Local de Saúde de Coimbra, E.P.E.
Coimbra
Cláudia Farinha
Unidade Local de Saúde de Leiria, E.P.E.
Leiria
Nuno Oliveira
Instituto Português de Microcirurgia Ocular, Lda.
Lisbon
José Roque
Unidade Local de Saúde de Lisboa Ocidental - Hospital de Egas Moniz
Lisbon
Maria Picoto
Unidade Local de Saúde Loures-Odivelas
Loures
Belmira Beltrán
Unidade Local de Saúde de Santo António, E.P.E.
Porto
Miguel Lume
Unidade Local de Saúde de São João, E.P.E.
Porto
Ângela Carneiro
About this study
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.
Read the detailed description
Age-related macular degeneration (AMD) constitutes a degenerative disease of the retina, and it is a major cause of retinal disease in the western world and one of the most common causes of central vision impairment, with the advanced form affecting 1-3% of its total population. Patients with AMD have a reduction in quality of life, as several activities of daily routine require functional central visual perception, such as driving and reading. Population aging will lead to a considerable increase in AMD prevalence. Today, late-stage AMD is the leading cause of blindness among the elderly in industrialized countries and affects more than 2.5 million patients in the European Union (EU) resulting in direct annual costs of over 2 billion Euros.
Advanced forms of AMD (intermediate AMD or late AMD) are seen primarily in 2 types, exudative AMD involving the presence of choroidal neovascularization and nonexudative or dry AMD with geographic atrophy.
Vascular endothelial growth factor (VEGF) is a major pathogenic factor in eAMD and is a signalling protein that is known to be involved in the pathophysiology of angiogenesis and increases vascular permeability. Medical treatment of neovascular (or exudative) AMD (eAMD) has improved considerably due to the introduction of vascular endothelial growth factor inhibitors (anti-VEGF), which have significantly altered the prognosis of the disease.
The current gold standard treatment of eAMD is regular intravitreal injections of anti-VEGF, such as Aflibercept, in a treat-and-extend (T\&E) or a fixed regimen. Aflibercept acts as a soluble protein for VEGF receptors inhibiting the predominant signaling pathway responsible for angiogenesis and vascular leakage. Currently, medications like Aflibercept 8 mg are used to treat and manage neovascular age-related macular degeneration, diabetic macular edema, myopic choroidal neovascularization, macular edema associated with retinal vein occlusion, and diabetic retinopathy. However, several patients do not respond adequately to this treatment or suffer a loss of efficacy after multiple administrations. In addition, current treatment with intravitreal anti-VEGF agents is associated with a significant treatment burden and costs for patients, caregivers, and physicians.
With these therapies, longer intervals up to 20 or 24 weeks can be achieved. However, there is a need to have real time information from these patients during such longer intervals, avoiding potential functional and/ or anatomical decline or treatment dropouts. Moreover, it is also pivotal to evaluate potential longer treatment intervals without lower clinical outcomes to reassure the confidence in these longer intervals.
The purpose of home-monitoring is to reduce any delay in the treatment of eAMD. This is through 3 mechanisms:
- Improved patient literacy: patients being provided with standardised information that helps them to self-care: understanding their disease, treatments and what support services are available, and what the red-flag symptoms are that the patient should be quickly re-presenting to their eye clinic if they encounter.
- Patient participation in monitoring: remote vision data gathered frequently and viewed by the patient gives them the opportunity for identifying smaller changes at an earlier stage.
- Clinical teams having access to remote-monitoring vision data: remote vision data gathered frequently and viewed by a specialist gives them the opportunity for identifying smaller changes at an earlier stage, especially with the support of AI-driven algorithms.
Additionally, by helping eAMD patients achieve the best clinical outcomes without the demands of monthly or frequent visits, these new technologies may enhance their quality of life and decrease economic and social burden.
- Being tested
- Aflibercept 8mg
- Keywords
- Aflibercept 8 mg, Exudative Age-Related Macular Degeneration, Patient reported outcomes, Value-based Healthcare, Home monitoring app
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept 8mgDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
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.
The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
Measured: From baseline through month 12.
Proportion of patients gaining ≥5, ≥10, ≥15 letters in BCVA at 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.
The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
Measured: From baseline through month 24.
Proportion of patients with BCVA ≥69 letters at 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.
The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
Measured: From baseline through month 12.
Proportion of patients with BCVA ≥69 letters at 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.
The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
Measured: From baseline through month 24.
Average change in central retinal thickness (CRT) from baseline to month 12.
Central retinal thickness refers to the measurement of the retinal tissue thickness in the central region of the retina, assessed using Optical Coherence Tomography (OCT).
Measured: From baseline to month 12.
Average change in CRT from baseline to month 24.
Central retinal thickness refers to the measurement of the retinal tissue thickness in the central region of the retina, assessed using OCT.
Measured: From baseline to month 24.
Proportion of patients without fluid at foveal centre at month 12.
Fluid at foveal centre is measured using OCT.
Measured: Month 12.
Proportion of patients without fluid at foveal centre at month 24.
Fluid at foveal centre is measured using OCT.
Measured: Month 24.
Total number of visits during the two-year treatment period.
Count of the number of visits each participant performed during the two-year treatment period.
Measured: From baseline through end of study (24 months).
Total number of intravitreal injections during the two-year treatment period.
Count of the intravitreal injections each participant received during the two-year treatment period.
Measured: From baseline through end of study (24 months).
Proportion of patients with ≥ 12, ≥ 16, ≥20 weeks interval at month 12.
Proportions are based on the number of participants who have not discontinued the study at the end of the study. The treatment interval at a given visit is defined as the treatment interval decision followed at that visit.
Measured: Month 12.
Proportion of patients with ≥ 12, ≥ 16, ≥20 weeks interval at month 24.
Proportions are based on the number of participants who have not discontinued the study at the end of the study. The treatment interval at a given visit is defined as the treatment interval decision followed at that visit.
Measured: Month 24.
Proportion of accurate alert flags of the OKKO-identified alerts/patient-driven alerts/clinic-identified alerts.
Accurate alert flags are measured as similar change in clinical status of the OKKO-identified alerts/patient-driven alerts/clinic-identified alerts.
Measured: From baseline to the end of the study.
Proportion of inaccurate alert flags of the OKKO-identified alerts/patient-driven alerts/clinic-identified alerts.
Inaccurate alert flags are measured as no correlation change in clinical status found of the OKKO-identified alerts/patient-driven alerts/clinic-identified alerts.
Measured: From baseline to the end of the study.
Adherence to the home monitoring.
Adherence determined by patients who use the application to home-monitor VA and metamorphopsia at least weekly and have no more than 2 breaks of 3 weeks in a year.
Measured: From baseline to the end of the study.
Costs assigned to National Health System at month 12.
Costs assigned to National Health System are estimated through eCRF information such as number of visits, serious adverse events (SAEs) and hospitalizations.
Measured: Month 12.
Costs assigned to National Health System at month 24.
Costs assigned to National Health System are estimated through eCRF information such as number of visits, SAEs and hospitalizations.
Measured: Month 24.
Societal costs at month 12.
Societal costs are assessed using a Value-based Healthcare Questionnaire, to be filled by participant and accompaniments.
Measured: Month 12.
Societal costs at month 24.
Societal costs are assessed using a Value-based Healthcare Questionnaire, to be filled by participant and accompaniments.
Measured: Month 24.
Average change in National Eye Institute Visual Functioning Questionnaire 25 (NEI-VFQ-25) from baseline to month 12.
NEI-VFQ-25 is a validated questionnaire used to assess vision-specific health-related quality of life. All items are scored so that a higher score represents better functioning and each item is converted to a 0 to 100 scale.
Measured: From baseline to month 12.
Average change in EQ-5D five-level (EQ-5D-5L) descriptive system from baseline to month 12.
EQ-5D-5L is a validated questionnaire used to measure patient-reported health status and utility values. The questionnaire creates a 5-digit code from five health dimensions, scored as five levels, and the higher score represents worse outcome. The EQ-5D-5L also includes the EuroQol Visual Analogue Scale (EQ-VAS) on a 0 to 100 scale for self-rated health, which higher score means better outcome.
Measured: From baseline to month 12.
Average change in National Eye Institute Visual Functioning Questionnaire 25 (NEI-VFQ-25) from baseline to month 24.
NEI-VFQ-25 is a validated questionnaire used to assess vision-specific health-related quality of life. All items are scored so that a higher score represents better functioning and each item is converted to a 0 to 100 scale.
Measured: From baseline to month 24.
Average change in EQ-5D five-level (EQ-5D-5L) descriptive system from baseline to month 24.
EQ-5D-5L is a validated questionnaire used to measure patient-reported health status and utility values. The questionnaire creates a 5-digit code from five health dimensions, scored as five levels, and the higher score represents worse outcome. The EQ-5D-5L also includes the EuroQol Visual Analogue Scale (EQ-VAS) on a 0 to 100 scale for self-rated health, which higher score means better outcome.
Measured: From baseline to month 24.
System usability scale (SUS) score.
To evaluate user satisfaction and perceived usability of the system at month 12. The SUS uses a 0 to 5 scale for each sentence, which higher scores indicate better outcomes.
Measured: Month 12.
Net promoter score (NPS).
To evaluate user satisfaction and perceived usability of the system at month 12. The NPS uses a 0 to 10 scale, which higher score indicates better outcome.
Measured: Month 12.
Frequency of adverse events (AEs) at month 12.
To evaluate the safety associated with the inclusion of a home monitoring app in the eAMD patient pathway with respect to AEs.
Measured: From baseline to month 12.
Frequency of SAEs at month 12.
To evaluate the safety associated with the inclusion of a home monitoring app in the eAMD patient pathway with respect SAEs.
Measured: From baseline to month 12.
Frequency of AEs at month 24.
To evaluate the safety associated with the inclusion of a home monitoring app in the eAMD patient pathway with respect to AEs.
Measured: From baseline to month 24.
Frequency of SAEs at month 24.
To evaluate the safety associated with the inclusion of a home monitoring app in the eAMD patient pathway with respect to SAEs.
Measured: From baseline to month 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study startMay 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exudative Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association for Innovation and Biomedical Research on Light and Image
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07340372
- Sponsor's protocol ID
- 4C-2024-15
- Acronym
- HOME
- Status last verified
- May 2026
- First submitted
- 6 Jan 2026
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Monitoring in eAMD Treatment
- ClinicalTrials.gov ID
- NCT07340372
- Acronym / sponsor ID
- HOME / 4C-2024-15
- Keywords
- Aflibercept 8 mg, Exudative Age-Related Macular Degeneration, Patient reported outcomes, Value-based Healthcare, Home monitoring app
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Association for Innovation and Biomedical Research on Light and ImageUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Age-related macular degeneration (AMD) constitutes a degenerative disease of the retina, and it is a major cause of retinal disease in the western world and one of the most common causes of central vision impairment, with the advanced form affecting 1-3% of its total population. Patients with AMD have a reduction in quality of life, as several activities of daily routine require functional central visual perception, such as driving and reading. Population aging will lead to a considerable increase in AMD prevalence. Today, late-stage AMD is the leading cause of blindness among the elderly in industrialized countries and affects more than 2.5 million patients in the European Union (EU) resulting in direct annual costs of over 2 billion Euros.
Advanced forms of AMD (intermediate AMD or late AMD) are seen primarily in 2 types, exudative AMD involving the presence of choroidal neovascularization and nonexudative or dry AMD with geographic atrophy.
Vascular endothelial growth factor (VEGF) is a major pathogenic factor in eAMD and is a signalling protein that is known to be involved in the pathophysiology of angiogenesis and increases vascular permeability. Medical treatment of neovascular (or exudative) AMD (eAMD) has improved considerably due to the introduction of vascular endothelial growth factor inhibitors (anti-VEGF), which have significantly altered the prognosis of the disease.
The current gold standard treatment of eAMD is regular intravitreal injections of anti-VEGF, such as Aflibercept, in a treat-and-extend (T\&E) or a fixed regimen. Aflibercept acts as a soluble protein for VEGF receptors inhibiting the predominant signaling pathway responsible for angiogenesis and vascular leakage. Currently, medications like Aflibercept 8 mg are used to treat and manage neovascular age-related macular degeneration, diabetic macular edema, myopic choroidal neovascularization, macular edema associated with retinal vein occlusion, and diabetic retinopathy. However, several patients do not respond adequately to this treatment or suffer a loss of efficacy after multiple administrations. In addition, current treatment with intravitreal anti-VEGF agents is associated with a significant treatment burden and costs for patients, caregivers, and physicians.
With these therapies, longer intervals up to 20 or 24 weeks can be achieved. However, there is a need to have real time information from these patients during such longer intervals, avoiding potential functional and/ or anatomical decline or treatment dropouts. Moreover, it is also pivotal to evaluate potential longer treatment intervals without lower clinical outcomes to reassure the confidence in these longer intervals.
The purpose of home-monitoring is to reduce any delay in the treatment of eAMD. This is through 3 mechanisms:
- Improved patient literacy: patients being provided with standardised information that helps them to self-care: understanding their disease, treatments and what support services are available, and what the red-flag symptoms are that the patient should be quickly re-presenting to their eye clinic if they encounter.
- Patient participation in monitoring: remote vision data gathered frequently and viewed by the patient gives them the opportunity for identifying smaller changes at an earlier stage.
- Clinical teams having access to remote-monitoring vision data: remote vision data gathered frequently and viewed by a specialist gives them the opportunity for identifying smaller changes at an earlier stage, especially with the support of AI-driven algorithms.
Additionally, by helping eAMD patients achieve the best clinical outcomes without the demands of monthly or frequent visits, these new technologies may enhance their quality of life and decrease economic and social burden.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with eAMD with a diagnosis or under treatment for a period ≤ 1year.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aflibercept 8mgPatients 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. | Drug | – |
Primary outcome
Average change in best corrected visual acuity (BCVA) from baseline to month 12.
Time frame: From baseline and then at each of the subsequent visits until 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.
Average change in BCVA from baseline to month 24.
Time frame: From baseline and then at each of the subsequent visits until 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.
29 secondary outcomes
Proportion of patients gaining ≥5, ≥10, ≥15 letters in BCVA at month 12.
Time frame: From baseline through month 12.
Proportion of patients gaining ≥5, ≥10, ≥15 letters in BCVA at month 24.
Time frame: From baseline through month 24.
Proportion of patients with BCVA ≥69 letters at month 12.
Time frame: From baseline through month 12.
Proportion of patients with BCVA ≥69 letters at month 24.
Time frame: From baseline through month 24.
Average change in central retinal thickness (CRT) from baseline to month 12.
Time frame: From baseline to month 12.
Average change in CRT from baseline to month 24.
Time frame: From baseline to month 24.
Proportion of patients without fluid at foveal centre at month 12.
Time frame: Month 12.
Proportion of patients without fluid at foveal centre at month 24.
Time frame: Month 24.
Total number of visits during the two-year treatment period.
Time frame: From baseline through end of study (24 months).
Total number of intravitreal injections during the two-year treatment period.
Time frame: From baseline through end of study (24 months).
Proportion of patients with ≥ 12, ≥ 16, ≥20 weeks interval at month 12.
Time frame: Month 12.
Proportion of patients with ≥ 12, ≥ 16, ≥20 weeks interval at month 24.
Time frame: Month 24.
Proportion of accurate alert flags of the OKKO-identified alerts/patient-driven alerts/clinic-identified alerts.
Time frame: From baseline to the end of the study.
Proportion of inaccurate alert flags of the OKKO-identified alerts/patient-driven alerts/clinic-identified alerts.
Time frame: From baseline to the end of the study.
Adherence to the home monitoring.
Time frame: From baseline to the end of the study.
Costs assigned to National Health System at month 12.
Time frame: Month 12.
Costs assigned to National Health System at month 24.
Time frame: Month 24.
Societal costs at month 12.
Time frame: Month 12.
Societal costs at month 24.
Time frame: Month 24.
Average change in National Eye Institute Visual Functioning Questionnaire 25 (NEI-VFQ-25) from baseline to month 12.
Time frame: From baseline to month 12.
Average change in EQ-5D five-level (EQ-5D-5L) descriptive system from baseline to month 12.
Time frame: From baseline to month 12.
Average change in National Eye Institute Visual Functioning Questionnaire 25 (NEI-VFQ-25) from baseline to month 24.
Time frame: From baseline to month 24.
Average change in EQ-5D five-level (EQ-5D-5L) descriptive system from baseline to month 24.
Time frame: From baseline to month 24.
System usability scale (SUS) score.
Time frame: Month 12.
Net promoter score (NPS).
Time frame: Month 12.
Frequency of adverse events (AEs) at month 12.
Time frame: From baseline to month 12.
Frequency of SAEs at month 12.
Time frame: From baseline to month 12.
Frequency of AEs at month 24.
Time frame: From baseline to month 24.
Frequency of SAEs at month 24.
Time frame: From baseline to month 24.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exudative Age-Related Macular Degeneration, run by Association for Innovation and Biomedical Research on Light and Image at 8 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joana F Tavares, PhD (+351 239 480137, home@aibili.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average change in best corrected visual acuity (BCVA) from baseline to month 12. (time frame: From baseline and then at each of the subsequent visits until month 12.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.