Trial Outcomes & Findings for Transcorneal Electrostimulation for Therapy of Retinitis Pigmentosa (NCT NCT01837901)

Results Overview

Change in the area measured by kinetic visual field measurement

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

88 participants

Primary outcome timeframe

one year

Results posted on

2021-03-18

Participant Flow

Patients were recruited from the hospital's hereditary retinal degeneration clinic (Centre for Ophthalmology, University of Tuebingen, Tuebingen, Germany). Of 88 enrolled participants, 63 met the inclusion criteria and were randomized to treatment.

Participant milestones

Participant milestones
Measure	Sham OkuStim was used to determine the phosphene threshold, device was turned on but no stimulation was performed.	150% OkuStim was used to determine the phosphene threshold, and then to administer transcorneal electrostimulation with a stimulation strength corresponding to 150% of the patient's phosphene threshold.	200% OkuStim was used to determine the phosphene threshold, and then to administer transcorneal electrostimulation with a stimulation strength corresponding to 200% of the patient's phosphene threshold.
Overall Study STARTED	22	21	20
Overall Study COMPLETED	20	15	17
Overall Study NOT COMPLETED	2	6	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transcorneal Electrostimulation for Therapy of Retinitis Pigmentosa

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sham n=20 Participants Device was turned on but no stimulation was performed.	150% n=15 Participants Transcorneal electrostimulation with 150% of phosphene threshold.	200% n=17 Participants Transcorneal electrostimulation with 200% of phosphene threshold.	Total n=52 Participants Total of all reporting groups
Age, Continuous	48 years STANDARD_DEVIATION 15 • n=99 Participants	42 years STANDARD_DEVIATION 13 • n=107 Participants	49 years STANDARD_DEVIATION 16 • n=206 Participants	46 years STANDARD_DEVIATION 15 • n=7 Participants
Sex: Female, Male Female	11 Participants n=99 Participants	7 Participants n=107 Participants	7 Participants n=206 Participants	25 Participants n=7 Participants
Sex: Female, Male Male	9 Participants n=99 Participants	8 Participants n=107 Participants	10 Participants n=206 Participants	27 Participants n=7 Participants
Region of Enrollment Germany	20 participants n=99 Participants	15 participants n=107 Participants	17 participants n=206 Participants	52 participants n=7 Participants

PRIMARY outcome

Timeframe: one year

Change in the area measured by kinetic visual field measurement

Outcome measures

Outcome measures
Measure	Sham n=20 Participants Device was turned on but no stimulation was performed.	150% n=14 Participants Transcorneal electrostimulation with 150% of phosphene threshold.	200% n=17 Participants Transcorneal electrostimulation with 200% of phosphene threshold.
Visual Field, III4e Baseline	4835.29 deg2 Interval 2723.26 to 6947.32	4988.43 deg2 Interval 2799.14 to 7177.73	6234.59 deg2 Interval 4226.84 to 8242.34
Visual Field, III4e 1 year	4488.39 deg2 Interval 2473.83 to 6502.95	4962.76 deg2 Interval 2765.44 to 7160.08	5878.75 deg2 Interval 3926.21 to 7831.28

PRIMARY outcome

Timeframe: one year

Change in the area measured by kinetic visual field measurement

Outcome measures

Outcome measures
Measure	Sham n=20 Participants Device was turned on but no stimulation was performed.	150% n=14 Participants Transcorneal electrostimulation with 150% of phosphene threshold.	200% n=17 Participants Transcorneal electrostimulation with 200% of phosphene threshold.
Visual Field, V4e Baseline	7135.77 deg2 Interval 4771.87 to 9499.66	7599.65 deg2 Interval 5004.8 to 10194.5	8303.59 deg2 Interval 6217.92 to 10389.27
Visual Field, V4e 1 year	6730.20 deg2 Interval 4459.71 to 9000.69	7641.55 deg2 Interval 4945.26 to 10337.84	8112.18 deg2 Interval 6028.01 to 10196.34

SECONDARY outcome

Timeframe: one year

Outcome measures

Outcome data not reported

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

200%

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sham n=22 participants at risk Device was turned on but no stimulation was performed.	150% n=21 participants at risk Transcorneal electrostimulation with 150% of phosphene threshold.	200% n=20 participants at risk Transcorneal electrostimulation with 200% of phosphene threshold.
General disorders Non-Ocular Adverse Events Total	45.5% 10/22 • Number of events 16 • 52 weeks treatment, follow-up visit after 72 weeks. AEs were recorded until the follow-up visit at 72 weeks.	52.4% 11/21 • Number of events 20 • 52 weeks treatment, follow-up visit after 72 weeks. AEs were recorded until the follow-up visit at 72 weeks.	55.0% 11/20 • Number of events 17 • 52 weeks treatment, follow-up visit after 72 weeks. AEs were recorded until the follow-up visit at 72 weeks.
Eye disorders Macular edema	4.5% 1/22 • Number of events 1 • 52 weeks treatment, follow-up visit after 72 weeks. AEs were recorded until the follow-up visit at 72 weeks.	0.00% 0/21 • 52 weeks treatment, follow-up visit after 72 weeks. AEs were recorded until the follow-up visit at 72 weeks.	0.00% 0/20 • 52 weeks treatment, follow-up visit after 72 weeks. AEs were recorded until the follow-up visit at 72 weeks.
Eye disorders Dry Eye Symptom	9.1% 2/22 • Number of events 2 • 52 weeks treatment, follow-up visit after 72 weeks. AEs were recorded until the follow-up visit at 72 weeks.	66.7% 14/21 • Number of events 24 • 52 weeks treatment, follow-up visit after 72 weeks. AEs were recorded until the follow-up visit at 72 weeks.	70.0% 14/20 • Number of events 22 • 52 weeks treatment, follow-up visit after 72 weeks. AEs were recorded until the follow-up visit at 72 weeks.
Eye disorders Ocular discomfort	9.1% 2/22 • Number of events 2 • 52 weeks treatment, follow-up visit after 72 weeks. AEs were recorded until the follow-up visit at 72 weeks.	9.5% 2/21 • Number of events 2 • 52 weeks treatment, follow-up visit after 72 weeks. AEs were recorded until the follow-up visit at 72 weeks.	5.0% 1/20 • Number of events 4 • 52 weeks treatment, follow-up visit after 72 weeks. AEs were recorded until the follow-up visit at 72 weeks.
Eye disorders Ocular pain	9.1% 2/22 • Number of events 3 • 52 weeks treatment, follow-up visit after 72 weeks. AEs were recorded until the follow-up visit at 72 weeks.	9.5% 2/21 • Number of events 3 • 52 weeks treatment, follow-up visit after 72 weeks. AEs were recorded until the follow-up visit at 72 weeks.	0.00% 0/20 • 52 weeks treatment, follow-up visit after 72 weeks. AEs were recorded until the follow-up visit at 72 weeks.
Eye disorders Subjective visual decrease	4.5% 1/22 • Number of events 1 • 52 weeks treatment, follow-up visit after 72 weeks. AEs were recorded until the follow-up visit at 72 weeks.	0.00% 0/21 • 52 weeks treatment, follow-up visit after 72 weeks. AEs were recorded until the follow-up visit at 72 weeks.	0.00% 0/20 • 52 weeks treatment, follow-up visit after 72 weeks. AEs were recorded until the follow-up visit at 72 weeks.
Eye disorders Skin irritation due to electrode	0.00% 0/22 • 52 weeks treatment, follow-up visit after 72 weeks. AEs were recorded until the follow-up visit at 72 weeks.	4.8% 1/21 • Number of events 1 • 52 weeks treatment, follow-up visit after 72 weeks. AEs were recorded until the follow-up visit at 72 weeks.	0.00% 0/20 • 52 weeks treatment, follow-up visit after 72 weeks. AEs were recorded until the follow-up visit at 72 weeks.
Eye disorders Ocular infection	0.00% 0/22 • 52 weeks treatment, follow-up visit after 72 weeks. AEs were recorded until the follow-up visit at 72 weeks.	4.8% 1/21 • Number of events 1 • 52 weeks treatment, follow-up visit after 72 weeks. AEs were recorded until the follow-up visit at 72 weeks.	0.00% 0/20 • 52 weeks treatment, follow-up visit after 72 weeks. AEs were recorded until the follow-up visit at 72 weeks.
Eye disorders Corneal erosion	0.00% 0/22 • 52 weeks treatment, follow-up visit after 72 weeks. AEs were recorded until the follow-up visit at 72 weeks.	0.00% 0/21 • 52 weeks treatment, follow-up visit after 72 weeks. AEs were recorded until the follow-up visit at 72 weeks.	5.0% 1/20 • Number of events 1 • 52 weeks treatment, follow-up visit after 72 weeks. AEs were recorded until the follow-up visit at 72 weeks.
Eye disorders General and ocular infection	0.00% 0/22 • 52 weeks treatment, follow-up visit after 72 weeks. AEs were recorded until the follow-up visit at 72 weeks.	0.00% 0/21 • 52 weeks treatment, follow-up visit after 72 weeks. AEs were recorded until the follow-up visit at 72 weeks.	5.0% 1/20 • Number of events 1 • 52 weeks treatment, follow-up visit after 72 weeks. AEs were recorded until the follow-up visit at 72 weeks.

Additional Information

Dr. R. Schippert

Okuvision GmbH

Phone: +49 7121 15935

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60