MacTel (Macular Telangiectasia) Type 2
Conditions
Brief summary
This was a prospective, multicenter, single-masked, sham-controlled extension study designed to provide long-term safety and efficacy follow-up data for subjects with MacTel who had NT-501 implanted intraocularly and/or underwent sham surgery in the respective precursor study (NTMT-01 or NTMT-02). A substudy was conducted in which subjects enrolled in study (NTMT-02), who had 1 study-eligible eye that underwent sham surgery, were offered the option to have NT-501 implanted in the same study eye. Of the 19 subjects who had 1 study-eligible eye and underwent sham surgery in the Cohort 2 precursor study (NTMT-02), 16 subjects elected to have NT-501 implanted in the same study eye during the substudy
Interventions
BIOLOGICALCiliary neurotrophic factor (CNTF)
The investigational product is the NT-501 encapsulated cell system, which consists of cells encapsulated within a semi-permeable polymer membrane and supportive matrices. NT-501 contains NTC-201 cells that secrete recombinant human CNTF, which were derived from genetically modified NTC-200 cells.
PROCEDURESurgery
Surgery to implant device for NT-501
Sponsors
Neurotech Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Previously enrolled in the NTMT-01 or NTMT-02 protocol and received the NT-501 implant and/or underwent a Sham procedure * Participant must be offered sufficient opportunity to review and to understand the informed consent form, agree to the form's contents, and provide written informed consent.
Exclusion criteria
* There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1 | 72, 84, 96, and 108 months (based on participants' original implant date during precursor study) | Change from baseline to 72, 84, 96 and 108 months post-surgery (based on participants' original implant date during precursor study) by SD-OCT for Cohort 1 |
| Ellipsoid Zone (Area of IS/OS Loss) - Cohort 2 | Baseline to 36, 48, 60 and 72 Months post-surgery (based on participants' original implant date during precursor study) | Change in EZ from baseline to 36, 48, 60 and 72 Months post-surgery (based on participants' original implant date during precursor study). Cohort 2 sham surgery arm includes 16 participants (16 eyes) that received an NT-501 following their Month 36 follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Retinal Sensitivity (dB) From Baseline - Cohort 2 Only | Baseline to 72 Months (based on participants' original implant date) | Baseline to 72 Months - analyses also presented for additional times: 36, 48, and 60 Months post-surgery (based on participants' original implant date during precursor study) . Cohort 2 sham surgery arm includes 16 participants (16 eyes) that received an NT-501 following their Month 36 follow-up in this study. |
| Change in BCVA From Baseline for Cohort 1 | Baseline to 108 Months (based on participants' original implant date) | Baseline to 108 Months - analyses also presented for additional times: 84, 96 and 108 Months (based on participants' original implant date) |
| Change in BCVA From Baseline for Cohort 2 | Baseline to 72 Months (based on participants' original implant date) | Baseline to 72 Months - analyses also presented for additional times: 36, 48, and 60 Months (based on participants' original implant date during precursor study) . Cohort 2 sham surgery arm includes 16 participants (16 eyes) that received an NT-501 following their Month 36 follow-up |
| Change in Reading Speed From Baseline - Cohort 2 Only | Baseline to 72 Months (based on participants' original implant date) | Baseline to 72 Months - analyses also presented for additional times: 36, 48, and 60 Months (based on participants' original implant date during precursor study) . Cohort 2 sham surgery arm includes 16 participants (16 eyes) that received an NT-501 following their Month 36 follow-up. Note: there were |
Countries
Australia, United States
Participant flow
Pre-assignment details
Cohort 1: Six subjects consented to the extension study, totaling six study eyes and six fellow eyes. Cohort 2: In NTMT-02, 64 subjects joined the extension study: NT-501 group: 15 subjects (15 study eyes, 15 fellow eyes). Sham group: 19 subjects (19 study eyes, 19 fellow eyes). Sham+NT-501 group: 30 subjects (1 implanted, 1 sham eye each). Cohort 2 included 128 eyes: 94 study eyes (45 NT-501, 49 sham) and 34 fellow eyes.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 - Implant Only Participants who completed protocol NTMT-01 and had one NT-501 implant. | 6 |
| Cohort 2 - Sham Only Participants who completed protocol NTMT-02 and only had a sham surgery. Note, there is a subset of these participants who opted to receive an actual NT-501 implant during the extension study. | 19 |
| Cohort 2 - NT-501 Implant Participants who completed protocol NTMT-02 and had one NT-501 implant.. | 15 |
| Cohort 2 - Sham + NT-501 Implant Participants who completed protocol NTMT-02 and had one NT-501 implant in one eye and sham surgery in the other. | 30 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 |
| Overall Study | COVID-19 | 0 | 1 | 0 | 1 |
| Overall Study | Death | 0 | 0 | 1 | 1 |
| Overall Study | Other Health Reason | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Cohort 2 - Sham + NT-501 Implant | Total | Cohort 1 - Implant Only | Cohort 2 - Sham Only | Cohort 2 - NT-501 Implant |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 22 Participants | 0 Participants | 3 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 48 Participants | 6 Participants | 16 Participants | 10 Participants |
| Age, Continuous | 63.6 years STANDARD_DEVIATION 8.59 | 61.4 years STANDARD_DEVIATION 8.99 | 53.8 years STANDARD_DEVIATION 5.12 | 59.4 years STANDARD_DEVIATION 7.61 | 59.5 years STANDARD_DEVIATION 10.82 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 67 Participants | 6 Participants | 18 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 8 Participants | 1 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) White | 28 Participants | 59 Participants | 4 Participants | 16 Participants | 11 Participants |
| Sex: Female, Male Female | 20 Participants | 44 Participants | 4 Participants | 11 Participants | 9 Participants |
| Sex: Female, Male Male | 10 Participants | 26 Participants | 2 Participants | 8 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 19 | 1 / 15 | 1 / 30 |
| other Total, other adverse events | 6 / 6 | 18 / 19 | 14 / 15 | 20 / 30 |
| serious Total, serious adverse events | 2 / 6 | 3 / 19 | 4 / 15 | 7 / 30 |
Outcome results
Primary
Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1
Change from baseline to 72, 84, 96 and 108 months post-surgery (based on participants' original implant date during precursor study) by SD-OCT for Cohort 1
Time frame: 72, 84, 96, and 108 months (based on participants' original implant date during precursor study)
Population: All enrolled participants by eye
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 - Fellow Eye | Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1 | 72 Months Post-Surgery Actual | 1.37 mm2 | Standard Deviation 1.4648 |
| Cohort 1 - Fellow Eye | Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1 | 96 Months Post-Surgery Actual | 1.338 mm2 | Standard Deviation 1.3264 |
| Cohort 1 - Fellow Eye | Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1 | 84 Months Post-Surgery Actual | 1.241 mm2 | Standard Deviation 1.4691 |
| Cohort 1 - Fellow Eye | Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1 | 96 Months Post-Surgery Change from Baseline | 0.642 mm2 | Standard Deviation 0.6922 |
| Cohort 1 - Fellow Eye | Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1 | 72 Months Post-Surgery Change from Baseline | 0.620 mm2 | Standard Deviation 0.7526 |
| Cohort 1 - Fellow Eye | Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1 | 108 Months Post-Surgery Actual | 0.394 mm2 | Standard Deviation 0.5156 |
| Cohort 1 - Fellow Eye | Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1 | 84 Months Post-Surgery Change from Baseline | 0.705 mm2 | Standard Deviation 0.7474 |
| Cohort 1 - Fellow Eye | Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1 | 108 Months Post-Surgery Change from Baseline | 0.165 mm2 | Standard Deviation 0.1558 |
| Cohort 1 - Fellow Eye | Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1 | Baseline | 0.697 mm2 | Standard Deviation 0.8334 |
| Cohort 1 - NT-501 Implant | Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1 | 108 Months Post-Surgery Change from Baseline | 0.277 mm2 | Standard Deviation 0.4605 |
| Cohort 1 - NT-501 Implant | Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1 | Baseline | 0.629 mm2 | Standard Deviation 0.08135 |
| Cohort 1 - NT-501 Implant | Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1 | 72 Months Post-Surgery Actual | 1.137 mm2 | Standard Deviation 1.2905 |
| Cohort 1 - NT-501 Implant | Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1 | 72 Months Post-Surgery Change from Baseline | 0.508 mm2 | Standard Deviation 0.6348 |
| Cohort 1 - NT-501 Implant | Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1 | 84 Months Post-Surgery Actual | 1.132 mm2 | Standard Deviation 1.1194 |
| Cohort 1 - NT-501 Implant | Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1 | 84 Months Post-Surgery Change from Baseline | 0.503 mm2 | Standard Deviation 0.5001 |
| Cohort 1 - NT-501 Implant | Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1 | 96 Months Post-Surgery Actual | 1.169 mm2 | Standard Deviation 1.0987 |
| Cohort 1 - NT-501 Implant | Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1 | 96 Months Post-Surgery Change from Baseline | 0.540 mm2 | Standard Deviation 0.5159 |
| Cohort 1 - NT-501 Implant | Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1 | 108 Months Post-Surgery Actual | 0.301 mm2 | Standard Deviation 0.4909 |
Primary
Ellipsoid Zone (Area of IS/OS Loss) - Cohort 2
Change in EZ from baseline to 36, 48, 60 and 72 Months post-surgery (based on participants' original implant date during precursor study). Cohort 2 sham surgery arm includes 16 participants (16 eyes) that received an NT-501 following their Month 36 follow-up
Time frame: Baseline to 36, 48, 60 and 72 Months post-surgery (based on participants' original implant date during precursor study)
Population: Intent to treat population by eye
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 - Fellow Eye | Ellipsoid Zone (Area of IS/OS Loss) - Cohort 2 | Change at 60 Months Post-Surgery | 0.450 mm2 | Standard Error 0.0644 |
| Cohort 1 - Fellow Eye | Ellipsoid Zone (Area of IS/OS Loss) - Cohort 2 | Baseline | 0.684 mm2 | Standard Error 0.0707 |
| Cohort 1 - Fellow Eye | Ellipsoid Zone (Area of IS/OS Loss) - Cohort 2 | Change at 36 Months Post-Surgery | 0.259 mm2 | Standard Error 0.0609 |
| Cohort 1 - Fellow Eye | Ellipsoid Zone (Area of IS/OS Loss) - Cohort 2 | Change at 48 Months Post-Surgery | 0.360 mm2 | Standard Error 0.0609 |
| Cohort 1 - Fellow Eye | Ellipsoid Zone (Area of IS/OS Loss) - Cohort 2 | Change at 72 Months Post-Surgery | 0.443 mm2 | Standard Error 0.0728 |
| Cohort 1 - NT-501 Implant | Ellipsoid Zone (Area of IS/OS Loss) - Cohort 2 | Change at 72 Months Post-Surgery | 0.497 mm2 | Standard Error 0.068 |
| Cohort 1 - NT-501 Implant | Ellipsoid Zone (Area of IS/OS Loss) - Cohort 2 | Change at 48 Months Post-Surgery | 0.282 mm2 | Standard Error 0.0589 |
| Cohort 1 - NT-501 Implant | Ellipsoid Zone (Area of IS/OS Loss) - Cohort 2 | Baseline | 0.766 mm2 | Standard Error 0.0687 |
| Cohort 1 - NT-501 Implant | Ellipsoid Zone (Area of IS/OS Loss) - Cohort 2 | Change at 60 Months Post-Surgery | 0.105 mm2 | Standard Error 0.076 |
| Cohort 1 - NT-501 Implant | Ellipsoid Zone (Area of IS/OS Loss) - Cohort 2 | Change at 36 Months Post-Surgery | 0.279 mm2 | Standard Error 0.0585 |
p-value: 0.545595% CI: [-0.226, 0.12]Mixed Models Analysis
Secondary
Change in BCVA From Baseline for Cohort 1
Baseline to 108 Months - analyses also presented for additional times: 84, 96 and 108 Months (based on participants' original implant date)
Time frame: Baseline to 108 Months (based on participants' original implant date)
Population: Intent to Treat population by eye
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 - Fellow Eye | Change in BCVA From Baseline for Cohort 1 | 84 Months Post-Surgery Change from Baseline | -7.8 letters | Standard Deviation 4.83 |
| Cohort 1 - Fellow Eye | Change in BCVA From Baseline for Cohort 1 | 72 Months Post-Surgery Change from Baseline | -7.7 letters | Standard Deviation 7.23 |
| Cohort 1 - Fellow Eye | Change in BCVA From Baseline for Cohort 1 | 96 Months Post-Surgery Actual | 72.7 letters | Standard Deviation 8.82 |
| Cohort 1 - Fellow Eye | Change in BCVA From Baseline for Cohort 1 | 72 Months Post-Surgery Actual | 72.8 letters | Standard Deviation 11.91 |
| Cohort 1 - Fellow Eye | Change in BCVA From Baseline for Cohort 1 | 96 Months Post-Surgery Change from Baseline | -7.8 letters | Standard Deviation 3.43 |
| Cohort 1 - Fellow Eye | Change in BCVA From Baseline for Cohort 1 | 84 Months Post-Surgery Actual | 72.7 letters | Standard Deviation 9.37 |
| Cohort 1 - Fellow Eye | Change in BCVA From Baseline for Cohort 1 | 108 Months Post-Surgery Actual | 72.5 letters | Standard Deviation 8.31 |
| Cohort 1 - Fellow Eye | Change in BCVA From Baseline for Cohort 1 | 108 Months Post-Surgery Change from Baseline | -8.0 letters | Standard Deviation 3.74 |
| Cohort 1 - Fellow Eye | Change in BCVA From Baseline for Cohort 1 | Baseline Actual | 80.5 letters | Standard Deviation 7.34 |
| Cohort 1 - NT-501 Implant | Change in BCVA From Baseline for Cohort 1 | 108 Months Post-Surgery Change from Baseline | -6.2 letters | Standard Deviation 3.37 |
| Cohort 1 - NT-501 Implant | Change in BCVA From Baseline for Cohort 1 | Baseline Actual | 75.0 letters | Standard Deviation 7.92 |
| Cohort 1 - NT-501 Implant | Change in BCVA From Baseline for Cohort 1 | 72 Months Post-Surgery Actual | 71.8 letters | Standard Deviation 7.76 |
| Cohort 1 - NT-501 Implant | Change in BCVA From Baseline for Cohort 1 | 72 Months Post-Surgery Change from Baseline | -3.2 letters | Standard Deviation 2.48 |
| Cohort 1 - NT-501 Implant | Change in BCVA From Baseline for Cohort 1 | 84 Months Post-Surgery Actual | 72.3 letters | Standard Deviation 6.65 |
| Cohort 1 - NT-501 Implant | Change in BCVA From Baseline for Cohort 1 | 84 Months Post-Surgery Change from Baseline | -2.7 letters | Standard Deviation 2.8 |
| Cohort 1 - NT-501 Implant | Change in BCVA From Baseline for Cohort 1 | 96 Months Post-Surgery Actual | 72.3 letters | Standard Deviation 6.22 |
| Cohort 1 - NT-501 Implant | Change in BCVA From Baseline for Cohort 1 | 96 Months Post-Surgery Change from Baseline | -2.7 letters | Standard Deviation 3.2 |
| Cohort 1 - NT-501 Implant | Change in BCVA From Baseline for Cohort 1 | 108 Months Post-Surgery Actual | 68.8 letters | Standard Deviation 10.3 |
Secondary
Change in BCVA From Baseline for Cohort 2
Baseline to 72 Months - analyses also presented for additional times: 36, 48, and 60 Months (based on participants' original implant date during precursor study) . Cohort 2 sham surgery arm includes 16 participants (16 eyes) that received an NT-501 following their Month 36 follow-up
Time frame: Baseline to 72 Months (based on participants' original implant date)
Population: Intent to Treat population by eye
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 - Fellow Eye | Change in BCVA From Baseline for Cohort 2 | Change at 36 Months Post-Surgery | -4.8 letters | Standard Error 0.8 |
| Cohort 1 - Fellow Eye | Change in BCVA From Baseline for Cohort 2 | Change at 60 Months Post-Surgery | -8.5 letters | Standard Error 0.82 |
| Cohort 1 - Fellow Eye | Change in BCVA From Baseline for Cohort 2 | Change at 48 Months Post-Surgery | -5.7 letters | Standard Error 0.81 |
| Cohort 1 - Fellow Eye | Change in BCVA From Baseline for Cohort 2 | Change at 72 Months Post-Surgery | -10.1 letters | Standard Error 0.87 |
| Cohort 1 - Fellow Eye | Change in BCVA From Baseline for Cohort 2 | Baseline | 77.2 letters | Standard Error 0.97 |
| Cohort 1 - NT-501 Implant | Change in BCVA From Baseline for Cohort 2 | Change at 72 Months Post-Surgery | -6.9 letters | Standard Error 0.83 |
| Cohort 1 - NT-501 Implant | Change in BCVA From Baseline for Cohort 2 | Baseline | 77.0 letters | Standard Error 0.93 |
| Cohort 1 - NT-501 Implant | Change in BCVA From Baseline for Cohort 2 | Change at 36 Months Post-Surgery | -3.2 letters | Standard Error 0.77 |
| Cohort 1 - NT-501 Implant | Change in BCVA From Baseline for Cohort 2 | Change at 48 Months Post-Surgery | -3.9 letters | Standard Error 0.78 |
| Cohort 1 - NT-501 Implant | Change in BCVA From Baseline for Cohort 2 | Change at 60 Months Post-Surgery | -3.9 letters | Standard Error 0.79 |
Secondary
Change in Reading Speed From Baseline - Cohort 2 Only
Baseline to 72 Months - analyses also presented for additional times: 36, 48, and 60 Months (based on participants' original implant date during precursor study) . Cohort 2 sham surgery arm includes 16 participants (16 eyes) that received an NT-501 following their Month 36 follow-up. Note: there were
Time frame: Baseline to 72 Months (based on participants' original implant date)
Population: Intent to Treat population by eye and based on participants who completed the reading speed assessment each timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 - Fellow Eye | Change in Reading Speed From Baseline - Cohort 2 Only | Reading Speed Change at 36 Months Post-Surgery | -8.838 words per minute | Standard Error 5.4428 |
| Cohort 1 - Fellow Eye | Change in Reading Speed From Baseline - Cohort 2 Only | Reading Speed Change at 60 Months Post-Surgery | -28.627 words per minute | Standard Error 5.6369 |
| Cohort 1 - Fellow Eye | Change in Reading Speed From Baseline - Cohort 2 Only | Reading Speed Change at 48 Months Post-Surgery | -18.931 words per minute | Standard Error 5.5846 |
| Cohort 1 - Fellow Eye | Change in Reading Speed From Baseline - Cohort 2 Only | Reading Speed Change at 72 Months Post-Surgery | -24.713 words per minute | Standard Error 5.9294 |
| Cohort 1 - Fellow Eye | Change in Reading Speed From Baseline - Cohort 2 Only | Baseline | 94.740 words per minute | Standard Error 6.4973 |
| Cohort 1 - NT-501 Implant | Change in Reading Speed From Baseline - Cohort 2 Only | Reading Speed Change at 72 Months Post-Surgery | -34.478 words per minute | Standard Error 5.6311 |
| Cohort 1 - NT-501 Implant | Change in Reading Speed From Baseline - Cohort 2 Only | Baseline | 107.222 words per minute | Standard Error 6.2866 |
| Cohort 1 - NT-501 Implant | Change in Reading Speed From Baseline - Cohort 2 Only | Reading Speed Change at 36 Months Post-Surgery | -17.798 words per minute | Standard Error 5.2686 |
| Cohort 1 - NT-501 Implant | Change in Reading Speed From Baseline - Cohort 2 Only | Reading Speed Change at 48 Months Post-Surgery | -25.488 words per minute | Standard Error 5.3072 |
| Cohort 1 - NT-501 Implant | Change in Reading Speed From Baseline - Cohort 2 Only | Reading Speed Change at 60 Months Post-Surgery | -18.324 words per minute | Standard Error 5.4825 |
Secondary
Change in Retinal Sensitivity (dB) From Baseline - Cohort 2 Only
Baseline to 72 Months - analyses also presented for additional times: 36, 48, and 60 Months post-surgery (based on participants' original implant date during precursor study) . Cohort 2 sham surgery arm includes 16 participants (16 eyes) that received an NT-501 following their Month 36 follow-up in this study.
Time frame: Baseline to 72 Months (based on participants' original implant date)
Population: Intent to Treat population by eye
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 - Fellow Eye | Change in Retinal Sensitivity (dB) From Baseline - Cohort 2 Only | Baseline | 25.688 dB | Standard Error 0.3377 |
| Cohort 1 - Fellow Eye | Change in Retinal Sensitivity (dB) From Baseline - Cohort 2 Only | Retinal Sensitivity Change at 48 Months Post-Surgery | -2.312 dB | Standard Error 0.3376 |
| Cohort 1 - Fellow Eye | Change in Retinal Sensitivity (dB) From Baseline - Cohort 2 Only | Retinal Sensitivity Change at 60 Months Post-Surgery | -2.912 dB | Standard Error 0.3562 |
| Cohort 1 - Fellow Eye | Change in Retinal Sensitivity (dB) From Baseline - Cohort 2 Only | Retinal Sensitivity Change at 72 Months Post-Surgery | -3.047 dB | Standard Error 0.3674 |
| Cohort 1 - Fellow Eye | Change in Retinal Sensitivity (dB) From Baseline - Cohort 2 Only | Retinal Sensitivity Change at 36 Months Post-Surgery | -1.391 dB | Standard Error 0.3377 |
| Cohort 1 - NT-501 Implant | Change in Retinal Sensitivity (dB) From Baseline - Cohort 2 Only | Retinal Sensitivity Change at 72 Months Post-Surgery | -2.909 dB | Standard Error 0.3595 |
| Cohort 1 - NT-501 Implant | Change in Retinal Sensitivity (dB) From Baseline - Cohort 2 Only | Baseline | 25.672 dB | Standard Error 0.3317 |
| Cohort 1 - NT-501 Implant | Change in Retinal Sensitivity (dB) From Baseline - Cohort 2 Only | Retinal Sensitivity Change at 36 Months Post-Surgery | -1.054 dB | Standard Error 0.332 |
| Cohort 1 - NT-501 Implant | Change in Retinal Sensitivity (dB) From Baseline - Cohort 2 Only | Retinal Sensitivity Change at 60 Months Post-Surgery | -2.369 dB | Standard Error 0.3347 |
| Cohort 1 - NT-501 Implant | Change in Retinal Sensitivity (dB) From Baseline - Cohort 2 Only | Retinal Sensitivity Change at 48 Months Post-Surgery | -1.965 dB | Standard Error 0.3319 |