Trial Outcomes & Findings for HOme Vision Monitoring in AREDS2 for Progression to Neovascular AMD Using the ForeseeHome Device (NCT NCT01103505)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1520 participants

Primary outcome timeframe

2 years

Results posted on

2019-07-30

Participant Flow

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

Participant milestones

Participant milestones
Measure	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.	Standard Care (Control) Arm Standard care instruction per clinic routine for home vision monitoring to detect progression of AMD.
Overall Study STARTED	763	757
Overall Study COMPLETED	739	737
Overall Study NOT COMPLETED	24	20

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

HOme Vision Monitoring in AREDS2 for Progression to Neovascular AMD Using the ForeseeHome Device

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Device Monitoring Arm n=763 Participants 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	Standard Care (Control) Arm n=757 Participants Standard care instruction per clinic routine for home vision monitoring to detect progression of AMD.	Total n=1520 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	104 Participants n=39 Participants	111 Participants n=41 Participants	215 Participants n=35 Participants
Age, Categorical >=65 years	659 Participants n=39 Participants	646 Participants n=41 Participants	1305 Participants n=35 Participants
Age, Continuous	72.6 Years STANDARD_DEVIATION 7.7 • n=39 Participants	72.3 Years STANDARD_DEVIATION 7.7 • n=41 Participants	72.5 Years STANDARD_DEVIATION 7.7 • n=35 Participants
Sex: Female, Male Female	444 Participants n=39 Participants	451 Participants n=41 Participants	895 Participants n=35 Participants
Sex: Female, Male Male	319 Participants n=39 Participants	306 Participants n=41 Participants	625 Participants n=35 Participants
Region of Enrollment United States	763 participants n=39 Participants	757 participants n=41 Participants	1520 participants n=35 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	ForeseeHome + Standard Care at CNV Progression n=51 Participants Patients who progressed from intermediate AMD to CNV and who were randomized to ForeseeHome use + Standard Care at the time CNV developed	Standard Care Alone (Control) at CNV Progression n=30 Participants Patients who progressed from intermediate AMD to CNV and were randomized to Standard Care alone (control arm) at the time CNV developed.
Primary Outcome: Change in Visual Acuity (LogMAR Letters) From Baseline to Detection of Choroidal Neovascularization	-7.4 LogMAR letters (ETDRS) Standard Deviation 11.4	-12.6 LogMAR letters (ETDRS) Standard Deviation 16.5

SECONDARY outcome

Timeframe: 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.

Percent of patients who maintained 20/40 or better vision at the time of CNV detection in each study arm

Outcome measures

Outcome measures
Measure	ForeseeHome + Standard Care at CNV Progression n=51 Participants Patients who progressed from intermediate AMD to CNV and who were randomized to ForeseeHome use + Standard Care at the time CNV developed	Standard Care Alone (Control) at CNV Progression n=30 Participants Patients who progressed from intermediate AMD to CNV and were randomized to Standard Care alone (control arm) at the time CNV developed.
Secondary Outcome: Patients Who Maintained 20/40 or Better Vision at Time of CNV Detection	87 percentage of patients	64 percentage of patients

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	ForeseeHome + Standard Care at CNV Progression n=39 Participants Patients who progressed from intermediate AMD to CNV and who were randomized to ForeseeHome use + Standard Care at the time CNV developed	Standard Care Alone (Control) at CNV Progression n=23 Participants Patients who progressed from intermediate AMD to CNV and were randomized to Standard Care alone (control arm) at the time CNV developed.
Secondary Outcome: Lesion Size (Total Lesion Area) at Time of Confirmed Progression to CNV	0.23 Disc Areas Interval 0.0 to 0.91	0.70 Disc Areas Interval 0.0 to 1.5

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	ForeseeHome + Standard Care at CNV Progression n=39 Participants Patients who progressed from intermediate AMD to CNV and who were randomized to ForeseeHome use + Standard Care at the time CNV developed	Standard Care Alone (Control) at CNV Progression n=23 Participants Patients who progressed from intermediate AMD to CNV and were randomized to Standard Care alone (control arm) at the time CNV developed.
Secondary Outcome: Lesion Size (CNV Area) at Time of Confirmed Progression to CNV	0.17 Disc Areas Interval 0.0 to 0.69	0.60 Disc Areas Interval 0.0 to 1.5

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	ForeseeHome + Standard Care at CNV Progression n=51 Participants Patients who progressed from intermediate AMD to CNV and who were randomized to ForeseeHome use + Standard Care at the time CNV developed	Standard Care Alone (Control) at CNV Progression n=30 Participants Patients who progressed from intermediate AMD to CNV and were randomized to Standard Care alone (control arm) at the time CNV developed.
Secondary Outcome: Lesion Size (Fluid Area) at Time of Confirmed Progression to CNV	0.55 Disc Areas Interval 0.0 to 1.15	0.90 Disc Areas Interval 0.0 to 2.2

Adverse Events

Device Monitoring Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care (Control) Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Grace Chang, MD, PhD

Notal Vision

Phone: 571-719-6416

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60