Age Related Macular Degeneration
Conditions
Keywords
AMD, CNV
Brief summary
The overall objective of this two arm randomized clinical trial (RCT) is to determine if home monitoring using the comprehensive visual field and telemedicine solution based on the ForeseeHome device in AREDS2 improves detection of progression to choroidal neovascularization (CNV) when compared with standard care.
Detailed description
The overall objective of this two arm randomized clinical trial (RCT) is to determine if home monitoring using the comprehensive visual field and telemedicine solution based on the ForeseeHome device in AREDS2 (referred to as the ForeseeHome comprehensive solution) participants at high risk of progression to neovascular AMD improves detection of progression to choroidal neovascularization (CNV) when compared with standard care. The primary outcome of this study is presenting best corrected visual acuity (BCVA) at the time of CNV diagnosis. Secondary outcomes include time to confirmed CNV diagnosis, lesion size, lesion location (extrafoveal, juxtafoveal, or subfoveal), lesion type (occult without classic, predominantly classic or minimally classic), sensitivity and specificity, and BCVA following three consecutive months of treatment and twelve months after the initial start of CNV treatment with an intravitreal anti-VEGF agent using either ranibizumab or bevacizumab. Outcomes will be ascertained via the following specific aims:
Interventions
DIAGNOSTIC_TESTForeseeHome AMD Monitoring Device
Earlier detection of progression from intermediate dry age-related macular degeneration to CNV between routine eye exams through home diagnostic testing with the ForeseeHome AMD Monitoring device
Sponsors
Notal Vision Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female participant between 55 and 90 years of age. Participants must have bilateral large drusen (at least 125 micron), or large drusen in the posterior pole in one eye (study eye) and advanced AMD (neovascular AMD or central geographic atrophy) in the fellow eye as determined by their study ophthalmologist. Likelihood, willingness, and ability to return for multiple visits (potentially within the same month) for at least 2 years. * Participant must be English speaking and understand and sign the protocol's informed consent document. * Participant must be able to successfully demonstrate their ability to comprehend instructions and use of the ForeseeHome device (a ForeseeHome device will be available at the clinic for the participant to demonstrate their ability). * Participant's address to which the ForeseeHome device will be sent, if randomized to the device monitoring arm, must be located in the U.S.A. * Study eye(s) must have best corrected visual acuity 20/60 or better (at least 54 letters). * Ocular media sufficient to allow adequate quality fundus photography. * Participant must be willing to have name and contact information provided to Notal Vision. * Participant must consent to be examined by the study ophthalmologist when changes in symptoms are detected by the home-device or by standard of care or when unreliable test results occur during the usage period. * If randomized to the device monitoring arm, participant must agree to take the device with them if staying somewhere else other than their primary residence for 14 days or more.
Exclusion criteria
* Participant has evidence of macular or retinal disorders other than AMD in the study eye(s). * Participant has known adverse reaction to fluorescein dye or refuses further fluorescein angiograms. * Participant's eye is receiving (or is expected to receive) an eye examination on a continuing basis by an eye care professional more frequently than every four months * NonAREDS2 participant currently enrolled in another study that may likely affect adherence with The HOME Study * Previous retinal or other ocular surgical procedures, the effects of which may now or in the future complicate assessment of the progression of AMD in the study eye. * Chronic requirement for any systemic or ocular medication administered for other diseases * Cataract surgery within one month of randomization. * Participant that has any condition that would make adherence to study follow up procedures for at least one year difficult or unlikely
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome: Change in Visual Acuity (LogMAR Letters) From Baseline to Detection of Choroidal Neovascularization | 2 years | Mean change in BCVA (logMAR letters) from baseline to the time of confirmed progression to CNV in the ForeseeHome device monitoring group compared to the standard care group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome: Patients Who Maintained 20/40 or Better Vision at Time of CNV Detection | 2 years | Percent of patients who maintained 20/40 or better vision at the time of CNV detection in each study arm |
| Secondary Outcome: Lesion Size (Total Lesion Area) at Time of Confirmed Progression to CNV | 2 years | Median lesion size (total lesion area) at time of confirmed progression to CNV as measured on fluorescein angiography (FA) will be compared between the two study arms. Lesion size was assessed, measured, and reported by optic disc areas, where 1 disc area = 2.54 mm\^2. |
| Secondary Outcome: Lesion Size (CNV Area) at Time of Confirmed Progression to CNV | 2 years | Median lesion size (CNV area) at time of confirmed progression to CNV as measured on fluorescein angiography will be compared between the two study arms. Lesion size was assessed, measured, and reported by optic disc areas, where 1 disc area = 2.54 mm\^2. |
| Secondary Outcome: Lesion Size (Fluid Area) at Time of Confirmed Progression to CNV | 2 years | Median lesion size (fluid area) at time of confirmed progression to CNV as measured on fluorescein angiography will be compared between the two study arms. Lesion size was assessed, measured, and reported by optic disc areas, where 1 disc area = 2.54 mm\^2. |
Countries
United States
Participant flow
Recruitment details
1970 Participants 53-90 Years of age at high risk of CNV developing were screened of these 1520 with mean age of 72.5 were enrolled at 44 clinical centers
Participants by arm
| Arm | Count |
|---|---|
| Device Monitoring Arm participants in the device monitoring arm will receive a packed device at home, with instructions to install and connect the device to a modem as well as instructions for daily use of the device.
ForeseeHome | 763 |
| Standard Care (Control) Arm Standard care instruction per clinic routine for home vision monitoring to detect progression of AMD. | 757 |
| Total | 1,520 |
Baseline characteristics
| Characteristic | Standard Care (Control) Arm | Device Monitoring Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 646 Participants | 659 Participants | 1305 Participants |
| Age, Categorical Between 18 and 65 years | 111 Participants | 104 Participants | 215 Participants |
| Age, Continuous | 72.3 Years STANDARD_DEVIATION 7.7 | 72.6 Years STANDARD_DEVIATION 7.7 | 72.5 Years STANDARD_DEVIATION 7.7 |
| Region of Enrollment United States | 757 participants | 763 participants | 1520 participants |
| Sex: Female, Male Female | 451 Participants | 444 Participants | 895 Participants |
| Sex: Female, Male Male | 306 Participants | 319 Participants | 625 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 763 | 0 / 757 |
| other Total, other adverse events | 0 / 763 | 0 / 757 |
| serious Total, serious adverse events | 0 / 763 | 0 / 757 |
Outcome results
Primary
Primary Outcome: Change in Visual Acuity (LogMAR Letters) From Baseline to Detection of Choroidal Neovascularization
Mean change in BCVA (logMAR letters) from baseline to the time of confirmed progression to CNV in the ForeseeHome device monitoring group compared to the standard care group.
Time frame: 2 years
Population: Patients in each study arm that progressed from intermediate AMD to CNV during the study were evaluated according to the primary and secondary endpoints. 51 of 763 patients in the device + standard care arm progressed to CNV during the trial, and 30 of 757 patients in the standard care alone arm progressed to CNV during the trial.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ForeseeHome + Standard Care at CNV Progression | Primary Outcome: Change in Visual Acuity (LogMAR Letters) From Baseline to Detection of Choroidal Neovascularization | -7.4 LogMAR letters (ETDRS) | Standard Deviation 11.4 |
| Standard Care Alone (Control) at CNV Progression | Primary Outcome: Change in Visual Acuity (LogMAR Letters) From Baseline to Detection of Choroidal Neovascularization | -12.6 LogMAR letters (ETDRS) | Standard Deviation 16.5 |
Secondary
Secondary Outcome: Lesion Size (CNV Area) at Time of Confirmed Progression to CNV
Median lesion size (CNV area) at time of confirmed progression to CNV as measured on fluorescein angiography will be compared between the two study arms. Lesion size was assessed, measured, and reported by optic disc areas, where 1 disc area = 2.54 mm\^2.
Time frame: 2 years
Population: Of 51 patients who progressed to CNV in the device arm, 39 had an FA performed, and of 30 patients who progressed to CNV in the standard care alone arm, 23 had an FA performed. Patients that progressed to CNV and had FAs performed were analyzed in this secondary analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ForeseeHome + Standard Care at CNV Progression | Secondary Outcome: Lesion Size (CNV Area) at Time of Confirmed Progression to CNV | 0.17 Disc Areas |
| Standard Care Alone (Control) at CNV Progression | Secondary Outcome: Lesion Size (CNV Area) at Time of Confirmed Progression to CNV | 0.60 Disc Areas |
Secondary
Secondary Outcome: Lesion Size (Fluid Area) at Time of Confirmed Progression to CNV
Median lesion size (fluid area) at time of confirmed progression to CNV as measured on fluorescein angiography will be compared between the two study arms. Lesion size was assessed, measured, and reported by optic disc areas, where 1 disc area = 2.54 mm\^2.
Time frame: 2 years
Population: 51 of 763 patients progressed to CNV in the device arm and 30 of 757 patients progressed to CNV in the standard care alone arm. Patients that progressed to CNV were analyzed in this secondary analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ForeseeHome + Standard Care at CNV Progression | Secondary Outcome: Lesion Size (Fluid Area) at Time of Confirmed Progression to CNV | 0.55 Disc Areas |
| Standard Care Alone (Control) at CNV Progression | Secondary Outcome: Lesion Size (Fluid Area) at Time of Confirmed Progression to CNV | 0.90 Disc Areas |
Secondary
Secondary Outcome: Lesion Size (Total Lesion Area) at Time of Confirmed Progression to CNV
Median lesion size (total lesion area) at time of confirmed progression to CNV as measured on fluorescein angiography (FA) will be compared between the two study arms. Lesion size was assessed, measured, and reported by optic disc areas, where 1 disc area = 2.54 mm\^2.
Time frame: 2 years
Population: Of 51 patients who progressed to CNV in the device arm, 39 had an FA performed, and of 30 patients who progressed to CNV in the standard care alone arm, 23 had an FA performed. Patients that progressed to CNV and had FAs performed were analyzed in this secondary analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ForeseeHome + Standard Care at CNV Progression | Secondary Outcome: Lesion Size (Total Lesion Area) at Time of Confirmed Progression to CNV | 0.23 Disc Areas |
| Standard Care Alone (Control) at CNV Progression | Secondary Outcome: Lesion Size (Total Lesion Area) at Time of Confirmed Progression to CNV | 0.70 Disc Areas |
Secondary
Secondary Outcome: Patients Who Maintained 20/40 or Better Vision at Time of CNV Detection
Percent of patients who maintained 20/40 or better vision at the time of CNV detection in each study arm
Time frame: 2 years
Population: 51 of 763 patients progressed to CNV in the device arm and 30 of 757 patients progressed to CNV in the standard care alone arm. Patients that progressed to CNV were analyzed in this secondary analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ForeseeHome + Standard Care at CNV Progression | Secondary Outcome: Patients Who Maintained 20/40 or Better Vision at Time of CNV Detection | 87 percentage of patients |
| Standard Care Alone (Control) at CNV Progression | Secondary Outcome: Patients Who Maintained 20/40 or Better Vision at Time of CNV Detection | 64 percentage of patients |