Home Monitoring in eAMD Treatment
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age55+
SponsorAssociation for Innovation and Biomedical Research on Light and Image
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 population
Patients with eAMD with a diagnosis or under treatment for a period ≤ 1year.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Aflibercept 8mg
DrugPatients 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
From baseline and then at each of the subsequent visits until month 12.2
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.
Time frame
From baseline and then at each of the subsequent visits until month 24.Secondary outcomes
1
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.
Time frame
From baseline through month 12.2
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.
Time frame
From baseline through month 24.3
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.
Time frame
From baseline through month 12.4
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.
Time frame
From baseline through month 24.Sponsors and contacts
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Source ClinicalTrials.gov
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