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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ForeseeHome AMD Monitoring Device | Other | 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 in addition to standard care |
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| Standard care alone (control) arm | No Intervention | Standard care instruction per clinic routine for home vision monitoring to detect progression of AMD and routine eye exams |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ForeseeHome AMD Monitoring Device | Diagnostic Test | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 years |
| Secondary Outcome: Lesion Size (Total Lesion Area) at Time of Confirmed Progression to CNV |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Emily Chew, MD | National Eye Institute (NEI) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jones Eye Institute - UAMS | Little Rock | Arkansas | 72205 | United States | ||
| Shiley Eye Center - UCSD |
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| Label | URL |
|---|---|
| Sponsor Home Page | View source |
| AREDS2 page | View source |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Standard Care (Control) Arm |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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. |
| 2 years |
| 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. | 2 years |
| 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. | 2 years |
| La Jolla |
| California |
| 92093 |
| United States |
| Loma Linda Univ. | Loma Linda | California | 92354 | United States |
| Univ. of California, Davis | Sacramento | California | 95817 | United States |
| Colorado Retina Assoc. | Denver | Colorado | 80230 | United States |
| Eldorado Retina Associates | Louisville | Colorado | 80027 | United States |
| Yale Univ. Eye Center | New Haven | Connecticut | United States |
| Univ. of Florida Health Science Center | Jacksonville | Florida | 32209 | United States |
| Bascom Palmer Eye Institute | Miami | Florida | 33136 | United States |
| Sarasota Retina Institute | Sarasota | Florida | 34239 | United States |
| Emory Univ. Eye Center | Atlanta | Georgia | 30322 | United States |
| Georgia Retina, P.C. | Decatur | Georgia | 30030 | United States |
| Retina Associates of Kentucky | Lexington | Kentucky | 40509 | United States |
| Elman Retina Group, PA | Baltimore | Maryland | 21237 | United States |
| Wilmer Eye Institute | Baltimore | Maryland | 21287 | United States |
| Retina Group of Washington | Chevy Chase | Maryland | 20815 | United States |
| Ophthalmic Cons. of Boston | Boston | Massachusetts | United States |
| Kresge Eye Institute | Detroit | Michigan | 48201 | United States |
| Vision Research Foundation | Grand Rapids | Michigan | 49546 | United States |
| Vision Research Foundation | Royal Oak | Michigan | 48073 | United States |
| Vision Research Foundation | Traverse City | Michigan | 49684 | United States |
| Delaware Valley Retina Associates | Lawrenceville | New Jersey | United States |
| Retina Research Foundation | Slingerlands | New York | 12159 | United States |
| Charlotte Eye Ear Nose and Throat Assoc | Charlotte | North Carolina | 28210 | United States |
| Duke Univ. | Durham | North Carolina | 27710 | United States |
| Case Western Reserve Univ. | Cleveland | Ohio | 44106 | United States |
| Retina Assoc. of Cleveland | Cleveland | Ohio | 44122 | United States |
| Pennsylvania Retina Specialists, P.C. | Camp Hill | Pennsylvania | 17011 | United States |
| Penn State M.S. Hershey Med Ctr | Hershey | Pennsylvania | 17033 | United States |
| Scheie Eye Institute | Philadelphia | Pennsylvania | 19104 | United States |
| UPMC Eye Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Univ. of Tennessee HSC | Memphis | Tennessee | 38103 | United States |
| Texas Retina Associates | Dallas | Texas | 75231 | United States |
| Retina Consult. of Houston | Houston | Texas | 77030 | United States |
| Texas Retina Associates | Lubbock | Texas | 79410 | United States |
| John Moran Eye Center, Univ. of Utah | Salt Lake City | Utah | 84132 | United States |
| Univ. of Wisconsin | Madison | Wisconsin | 53705 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
Standard care instruction per clinic routine for home vision monitoring to detect progression of AMD. |
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At baseline, all participants underwent Best corrected visual acuity testing and color fundus photography of 3 stereoscopic fields in both eyes.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Standard Care (Control) Arm | Standard care instruction per clinic routine for home vision monitoring to detect progression of AMD. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
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| 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. | 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. | Posted | Mean | Standard Deviation | LogMAR letters (ETDRS) | 2 years |
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| 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 | 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. | Posted | Number | percentage of patients | 2 years |
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| 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. | 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. | Posted | Median | Inter-Quartile Range | Disc Areas | 2 years |
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| 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. | 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. | Posted | Median | Inter-Quartile Range | Disc Areas | 2 years |
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| 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. | 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. | Posted | Median | Inter-Quartile Range | Disc Areas | 2 years |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Device Monitoring Arm | Participants in the ForeseeHome AMD device monitoring arm will receive a device for at home use, with instructions to install and connect the device to a modem as well as instructions for daily use of the device, in addition to standard care. | 0 | 763 | 0 | 763 | 0 | 763 |
| EG001 | Standard Care (Control) Arm | Standard care arm study participants will receive instruction per clinic routine for home vision monitoring (e.g. Amsler grid) to detect progression of AMD in addition to routine scheduled eye exams | 0 | 757 | 0 | 757 | 0 | 757 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grace Chang, MD, PhD | Notal Vision | 571-719-6416 | Grace.Chang@NotalVision.com |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| >=65 years |
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| Male |
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