Trial Outcomes & Findings for Argus® II Retinal Stimulation System Feasibility Protocol (NCT NCT00407602)

Last Updated: 2022-01-20

Results Overview

Grating Visual Acuity is performed at Baseline and at various timepoints throughout the study. As of the 10 year final testing, the total number of subjects that were able to score on the logMAR scale are indicated below. The device has a scale from 1.6 to 2.9 logMAR. Maximum likelihood estimation of visual acuity is based on BEST-PEST algorithm.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

10 years

Results posted on

2022-01-20

Participant Flow

Participant milestones

Participant milestones
Measure	Implant of Argus II Retinal Prosthesis This is a single group study where the status and performance of the implanted eye prior to surgery serves as the comparator. Argus II Retinal Stimulation System: epiretinal implantation of device
Overall Study STARTED	30
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Implant of Argus II Retinal Prosthesis This is a single group study where the status and performance of the implanted eye prior to surgery serves as the comparator. Argus II Retinal Stimulation System: epiretinal implantation of device
Overall Study Death - unrelated to device	1
Overall Study Device explanted	5
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Implant of Argus II Retinal Prosthesis n=30 Participants This is a single group study where the status and performance of the implanted eye prior to surgery serves as the comparator. Argus II Retinal Stimulation System: epiretinal implantation of device
Age, Categorical <=18 years	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=30 Participants
Age, Categorical >=65 years	6 Participants n=30 Participants
Age, Continuous	58.3 years n=30 Participants
Sex: Female, Male Female	9 Participants n=30 Participants
Sex: Female, Male Male	21 Participants n=30 Participants
Region of Enrollment United States	14 participants n=30 Participants
Region of Enrollment United Kingdom	10 participants n=30 Participants
Region of Enrollment France	4 participants n=30 Participants
Region of Enrollment Switzerland	2 participants n=30 Participants

PRIMARY outcome

Timeframe: 10 years

Outcome measures

Outcome measures
Measure	Single Arm n=13 Participants Only one arm in this study, treatment arm.
Visual Acuity	2 Participants

PRIMARY outcome

Timeframe: 10 years

Evaluate ocular adverse events reported for all subjects from day of implant through 10 years of study participation

Outcome measures

Outcome measures
Measure	Single Arm n=30 Participants Only one arm in this study, treatment arm.
Number of Participants With Adverse Events Total number of subjects with serious ocular AEs	13 participants
Number of Participants With Adverse Events Total number of subjects with non-serious ocular AEs	28 participants

SECONDARY outcome

Timeframe: 3 years

Population: Data for all 14 US subjects analyzed

The Massof Activity Inventory measures changes in ability to perform activities of daily living in terms of Goals and Tasks in logits (log-odds units). A logit scale is an equal interval linear scale that represents probability values in terms of real numbers. There is no minimum or maximum scale used in this testing. In this case, a Rasch distribution (using an Andrich rating model) was used to find the maximum likelihood of difficulty of achieving Goals and Tasks, represented in logits. The change in mean logit value between baseline and the 36Month visit for each subject are provided below along with the 95% confidence interval (CI) for the change. A positive change in the Goals or Tasks score which is greater than 0.2 (with a CI less than the mean logit value), is interpreted as a clinically significant increase in functional ability (better outcome).

Outcome measures

Outcome measures
Measure	Single Arm n=14 Participants Only one arm in this study, treatment arm.
Massof Activity Inventory S2-Goals	1.0 Logit scale Interval 0.18 to 1.82
Massof Activity Inventory S9-Tasks	0.8 Logit scale Interval -0.09 to 1.69
Massof Activity Inventory S10-Tasks	-0.4 Logit scale Interval -0.71 to -0.09
Massof Activity Inventory S11-Tasks	-0.2 Logit scale Interval -0.45 to 0.05
Massof Activity Inventory S12-Tasks	-0.3 Logit scale Interval -0.62 to 0.02
Massof Activity Inventory S13-Tasks	0.2 Logit scale Interval -0.11 to 0.51
Massof Activity Inventory Subject1-Goals	-0.1 Logit scale Interval -0.87 to 0.67
Massof Activity Inventory S3-Goals	0.3 Logit scale Interval -0.33 to 0.93
Massof Activity Inventory S4-Goals	0.1 Logit scale Interval -0.67 to 0.87
Massof Activity Inventory S5-Goals	0.1 Logit scale Interval -0.76 to 0.96
Massof Activity Inventory S6-Goals	-0.2 Logit scale Interval -0.8 to 0.4
Massof Activity Inventory S7-Goals	-1.6 Logit scale Interval -2.32 to -0.88
Massof Activity Inventory S8-Goals	0.9 Logit scale Interval 0.21 to 1.59
Massof Activity Inventory S9-Goals	0.2 Logit scale Interval -0.25 to 0.65
Massof Activity Inventory S10-Goals	-0.3 Logit scale Interval -0.86 to 0.26
Massof Activity Inventory S11-Goals	0.1 Logit scale Interval -0.51 to 0.71
Massof Activity Inventory S12-Goals	0.0 Logit scale Interval -0.57 to 0.57
Massof Activity Inventory S13-Goals	0.5 Logit scale Interval -0.16 to 1.16
Massof Activity Inventory S14 -Goals	NA Logit scale Error in test administration, data determined to be invalid.
Massof Activity Inventory S1-Tasks	0.4 Logit scale Interval -0.19 to 0.99
Massof Activity Inventory S2-Tasks	-0.2 Logit scale Interval -0.45 to 0.05
Massof Activity Inventory S3-Tasks	0.4 Logit scale Interval 0.16 to 0.64
Massof Activity Inventory S4-Tasks	-0.1 Logit scale Interval -0.46 to 0.26
Massof Activity Inventory S5-Tasks	0.6 Logit scale Interval 0.14 to 1.06
Massof Activity Inventory S6-Tasks	0.2 Logit scale Interval -0.06 to 0.46
Massof Activity Inventory S7-Tasks	-0.3 Logit scale Interval -0.81 to 0.21
Massof Activity Inventory S8-Tasks	2.0 Logit scale Interval 1.52 to 2.48
Massof Activity Inventory S14-Tasks	NA Logit scale Error in test administration, data determined to be invalid.

SECONDARY outcome

Timeframe: 3 years

Population: 30 subjects were analyzed comparing Baseline visit to the last visit when VisQOL was performed.

Quality of life is being measured using the VisQOL survey. This instrument, developed by researchers at the University of Melbourne, Australia, is a vision and quality of life-related utility measure intended to evaluate healthcare interventions for the visually impaired. The utility score is a preference-based measure of vision-related quality of life (Dimension 7 score (Health Dimension Score (1=Best, 0=Worst)). It measures subjective quality of life on a scale of 0 to 1, where 0 represents worst possible quality of life and 1 represents perfect quality of life.

Outcome measures

Outcome measures
Measure	Single Arm n=30 Participants Only one arm in this study, treatment arm.
Quality of Life - Tasks for Daily Living	.6191 units on a scale Standard Deviation .2146

SECONDARY outcome

Timeframe: 5 years

Population: Data for all 14 US subjects analyzed

Argus II System for orientation and mobility, each subject completed two tests (walking to a high-contrast "door" on the wall and following a straight line on the floor) at various timepoints throughout the study. Accuracy (percent of trials where the subject successfully reached the target) was measured with the device system ON and system OFF. Average % success rates across the analysis population are provided for each modality and for each test at the 60 month time point.

Outcome measures

Outcome measures
Measure	Single Arm n=14 Participants Only one arm in this study, treatment arm.
Orientation and Mobility Average % system ON-Door Task	58 percentage of successful trials Standard Deviation 24
Orientation and Mobility Average % system OFF-Line Task	10 percentage of successful trials Standard Deviation 13
Orientation and Mobility Average % system OFF-Door Task	18 percentage of successful trials Standard Deviation 19
Orientation and Mobility Average % system ON-Line Task	68 percentage of successful trials Standard Deviation 36

SECONDARY outcome

Timeframe: 10 years

Population: Data available only on 13 of the 14 US subjects

Square localization (SL) and Direction of Motion (DOM) testing performed at specific protocol intervals. SL tests ability of subjects to locate high-contrast square on black screen. DOM tests ability of subjects to determine the direction a white bar is moving over a black screen. Each test is performed with the system ON and then compared to performance with the system OFF. Number of subjects who performed significantly better with the system ON is indicated below.

Outcome measures

Outcome measures
Measure	Single Arm n=13 Participants Only one arm in this study, treatment arm.
Visual Function SL - Number of subjects with significantly better with system ON	9 Participants
Visual Function DOM - Number of subjects with significantly better with system ON	4 Participants

SECONDARY outcome

Timeframe: 5 years

Population: Data for all 14 US subjects analyzed

Stability of electrode array on the retina. Qualitative review of imaging: retinal and array landmarks compared from all time points post implant.

Outcome measures

Outcome measures
Measure	Single Arm n=14 Participants Only one arm in this study, treatment arm.
Stability of Implant - 5 Years Post Implant Stable position of array on Array position stable-no rotation	8 Participants
Stability of Implant - 5 Years Post Implant Minor array rotation	5 Participants
Stability of Implant - 5 Years Post Implant Inconclusive data	1 Participants

SECONDARY outcome

Timeframe: 10 years

Number of participants with functional devices 10 years post implant

Outcome measures

Outcome measures
Measure	Single Arm n=30 Participants Only one arm in this study, treatment arm.
Device Reliability	28 Participants

Adverse Events

Single Arm

Serious events: 13 serious events

Other events: 28 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm n=30 participants at risk Single arm with fellow eye as comparator
Eye disorders Conjunctival dehiscence	13.3% 4/30 • Number of events 4 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Conjunctival erosion	20.0% 6/30 • Number of events 9 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Corneal melt	3.3% 1/30 • Number of events 1 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Endophthalmitis - infective	13.3% 4/30 • Number of events 4 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Epiretinal membrane	3.3% 1/30 • Number of events 1 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Hypotony	16.7% 5/30 • Number of events 5 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Iris rubeosis	3.3% 1/30 • Number of events 1 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Keratitis - infective	3.3% 1/30 • Number of events 1 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Migration (extra-ocular) of intraocular silicone oil	3.3% 1/30 • Number of events 1 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Re-tack	6.7% 2/30 • Number of events 2 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Retinal detachment - rhegmatogenous	10.0% 3/30 • Number of events 3 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Retinal detachment - tractional and serous	3.3% 1/30 • Number of events 1 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Retinal tear	3.3% 1/30 • Number of events 1 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Uveitis	3.3% 1/30 • Number of events 1 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.

Other adverse events

Other adverse events
Measure	Single Arm n=30 participants at risk Single arm with fellow eye as comparator
Eye disorders 360 Circumferential Vitreous Band Traction	3.3% 1/30 • Number of events 1 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Choroidal detachment	20.0% 6/30 • Number of events 6 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Choroidal effusion	3.3% 1/30 • Number of events 1 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Conjunctival congestion	33.3% 10/30 • Number of events 11 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Conjunctival cyst	6.7% 2/30 • Number of events 2 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Conjunctival dehiscence	6.7% 2/30 • Number of events 2 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Conjunctival erosion	6.7% 2/30 • Number of events 2 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Conjunctivitis - inflammatory	13.3% 4/30 • Number of events 5 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Corneal abrasion	3.3% 1/30 • Number of events 1 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Corneal dryness	3.3% 1/30 • Number of events 1 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Corneal epithelial defect	3.3% 1/30 • Number of events 1 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Corneal fold	3.3% 1/30 • Number of events 1 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Corneal opacity	3.3% 1/30 • Number of events 1 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Corneal Suture Broken	6.7% 2/30 • Number of events 2 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Corneal vascularization	6.7% 2/30 • Number of events 2 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Decrease in light perception	3.3% 1/30 • Number of events 1 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Elective revision surgery	23.3% 7/30 • Number of events 7 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Epiphora	10.0% 3/30 • Number of events 3 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Epiretinal membrane	36.7% 11/30 • Number of events 11 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Fibrosis around retinal tack	6.7% 2/30 • Number of events 2 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Filamentary keratitis	3.3% 1/30 • Number of events 1 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Foreign Body Sensation	3.3% 1/30 • Number of events 2 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Headache	10.0% 3/30 • Number of events 3 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders High IOP	6.7% 2/30 • Number of events 2 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Hyphema	10.0% 3/30 • Number of events 3 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Hypotony	23.3% 7/30 • Number of events 8 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Inflammation - ocular	16.7% 5/30 • Number of events 5 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Irregular pupil	3.3% 1/30 • Number of events 1 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Keratic Precipitates	6.7% 2/30 • Number of events 3 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
General disorders Nausea	3.3% 1/30 • Number of events 1 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Nystagmus increase	3.3% 1/30 • Number of events 1 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Ocular fibrin	3.3% 1/30 • Number of events 1 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Pain - ocular	30.0% 9/30 • Number of events 18 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Pre-retinal hemorrhage	3.3% 1/30 • Number of events 1 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Proliferative Vitreoretinopathy	3.3% 1/30 • Number of events 1 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Ptosis	6.7% 2/30 • Number of events 2 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Retinal Break/Tear	3.3% 1/30 • Number of events 1 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Retinal detachment - tractional	3.3% 1/30 • Number of events 1 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Retinal folds	3.3% 1/30 • Number of events 1 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Retinal Thickening - cystoid macular edema (CME)	13.3% 4/30 • Number of events 4 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Retinal Thickening - without cystic changes	13.3% 4/30 • Number of events 4 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Retinoschisis	3.3% 1/30 • Number of events 2 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Revision Surgery - tack replacement	3.3% 1/30 • Number of events 1 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Rubeosis	3.3% 1/30 • Number of events 1 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Scleral graft displacement or reabsorption	6.7% 2/30 • Number of events 2 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Scleritis	3.3% 1/30 • Number of events 1 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
General disorders Suture irritation	20.0% 6/30 • Number of events 7 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Uveitis	16.7% 5/30 • Number of events 6 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
General disorders Vertigo	3.3% 1/30 • Number of events 1 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Eye disorders Vitreous hemorrhage	13.3% 4/30 • Number of events 4 • 10 years Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.

Additional Information

Jessy Dorn, PhD, Director of Clinical and Scientific Affiars

Second Sight Medical Products, Inc.

Phone: 8188335089

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place