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| Name | Class |
|---|---|
| CONVIDIA clinical research GmbH | UNKNOWN |
| Nubilaria Srl | UNKNOWN |
| TentaConsult Pharma & Med GmbH | UNKNOWN |
| Department of Ophthalmology, University Hospital Ulm, Germany |
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Geographic atrophy (GA) is a progressive eye disease that causes the degeneration of the retinal cells, particularly in the macula, leading to vision loss. The goal of this pilot study is to evaluate the safety and the effectiveness of transcorneal electrical stimulation (TES) therapy with the OkuStim 2 System in patients with geographic atrophy (GA).
Researchers will compare the effects of two different electrical stimuli with a placebo to see if the stimuli are safe and can slow down the progression of the disease.
Participants will be randomly assigned to one of these three groups:
Participants will apply the therapy at home, once a week for 30 minutes each over a duration of 1 year.
Geographic atrophy (GA) is a progressive eye disease that causes the degeneration of the retinal cells, particularly in the macula, leading to vision loss. Currently, there is no approved therapy specifically for GA in Europe.
The aim of this pilot study is to evaluate the safety and potential efficacy of the treatment of visual field defects in patients with GA using transcorneal electrical stimulation (TES) with the OkuStim 2 System. One of the main mechanisms for the loss of retinal cells in GA is inflammation. It is known from preclinical studies that electrical stimulation of the eye can inhibit inflammation or cellular reactions to inflammatory processes in the retina, trigger neuroprotective mechanisms and promote blood flow in the retina. The multicentric, randomized, double-masked, sham-controlled pilot study is based on the assumption that these mechanisms can maintain the functional integrity of the outer zone of the lesion area for longer.
Participants will be randomly assigned 1:1:1 to one of these three groups:
After an initial training phase, participants will apply the therapy at home, once a week for 30 minutes each over a duration of 1 year. Only one eye will be treated (study eye).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TES-treatment with a rectangular stimulus | Experimental | A ramp is applied in the beginning of the stimulation to avoid that the patient is startled by the onset of stimulation: 0µA to therapy amplitude, ramping up in 30 seconds. The therapy amplitude is then maintained for 30 minutes. The stimulation parameters are: symmetric biphasic rectangular pulse (anodic at first) with a frequency of 20 Hz and a pulse duration of 10ms (5ms each phase). Stimulation will be performed once per week, for 30 minutes, for 12 months. |
|
| TES-treatment with a repetitive ramp stimulus | Experimental | A ramp is applied in the beginning of the stimulation to avoid that the patient is startled by the onset of stimulation: 0µA to therapy amplitude, ramping up in 30 seconds. The therapy amplitude is then maintained for 30 minutes. The stimulation parameters are: ramp-down sawtooth current pulses (anodic first) with a frequency of 20 Hz. Stimulation will be performed once per week, for 30 minutes, for 12 months. |
|
| Sham group | Sham Comparator | The stimulation in the sham-group will be carried out with 0µA. Sham-stimulation will be performed once per week, for 30 minutes, for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcorneal electrical stimulation (TES) with the OkuStim 2 System | Device | In TES therapy with the OkuStim 2 System, retinal stimulation is achieved through transcorneal current application: using a thread electrode, the OkuEl M, a weak current (≤ 1mA) is introduced onto the surface of the eye, which spreads through the eye towards the retina. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of TES therapy in GA | Determined by the nature and number of device-related adverse events | From enrolment until the end of the study for the individual participant at 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of TES therapy with two different stimulus waveforms on the progression of GA lesion areas | Assessed by fundus autofluorescence (FAF) in combination with optical coherence tomography (OCT) | At 12 months and at timepoints in between (4, 17 and 34 weeks after the baseline-visit) compared to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of TES therapy with two different stimulus waveforms on functional changes in the GA border zone, depending on position of the microperimetry stimulus points relative to the foveal center | Assessed by patient-tailored microperimetry (mMAIA) | At 12 months and at timepoints in between (17 and 34 weeks after the baseline-visit) compared to baseline |
Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruth Schippert, PhD | Contact | +49 7121 15935 | 55 | studies@okuvision.de |
| Name | Affiliation | Role |
|---|---|---|
| Florian Gekeler, Prof. Dr. | Department of Ophthalmology, Klinikum Stuttgart, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, University Medical Center Hamburg-Eppendorf | Not yet recruiting | Hamburg | 20246 | Germany |
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| UNKNOWN |
| Department of Ophthalmology, Klinikum Stuttgart, Germany | UNKNOWN |
| Centre for Ophthalmology, University Hospital Tuebingen, Germany | UNKNOWN |
| Universitätsklinikum Hamburg-Eppendorf | OTHER |
| Department of Ophthalmology, Ludwig-Maximilians-University Munich, Germany | UNKNOWN |
| Steinbeis-Forschungszentrum, GRADE Reading Center | UNKNOWN |
| Clinical Study Core Unit SZB, Studienzentrum Bonn, University Hospital Bonn, Germany | UNKNOWN |
Patients are assigned 1:1:1 to one of three different groups: Sham group (sham treatment), biphasic rectangular pulses, or repetitive ramp stimulus.
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The patient is masked to the treatment group he or she has been assigned to. The programming of the stimulation parameters on the OkuStim 2 is carried out by unmasked members of the study team as it is impossible to program the OkuStim 2 without knowing the assignment of the patient to the study group. Examinations relating to the primary, secondary or exploratory endpoints are carried out only by masked team members.
|
| Transcorneal electrical stimulation (TES) with the OkuStim 2 System | Device | Sham-stimulation will be performed once per week, for 30 minutes, for 12 months without effective stimulation |
|
| Effects of TES therapy with two different stimulus waveforms on structural changes in retinal layers |
Assessed by OCT |
| At 12 months and at timepoints in between (4, 17 and 34 weeks after the baseline-visit) compared to baseline |
| Effects of TES therapy with two different stimulus waveforms on functional changes in the border zone of GA areas | Assessed by patient-tailored microperimetry (mMAIA) | At 12 months and at timepoints in between (17 and 34 weeks after the baseline-visit) compared to baseline |
| Effects of TES therapy with two different stimulus waveforms on visual acuity under normal luminance conditions | Assessed with ETDRS chart | At 12 months and at timepoints in between (4, 17 and 34 weeks after the baseline-visit) compared to baseline |
| Effects of TES therapy with two different stimulus waveforms on visual acuity under low-luminance conditions | Assessed with ETDRS chart and a neutral density filter | At 12 months and at timepoints in between (4, 17 and 34 weeks after the baseline-visit) compared to baseline |
| Effects of TES therapy with two different stimulus waveforms on patient-reported outcomes regarding the impact on daily life | Assessed with the Vision Impairment in Low Luminance (VILL-33) questionnaire | At 12 months compared to baseline |
| Effects of TES therapy with two different stimulus waveforms on patient-reported outcome regarding the applicability of the therapy under everyday conditions during home-use | Assessed with a custom-made questionnaire | At 12 months compared to baseline |
| Department of Ophthalmology, Ludwig-Maximilians-University Munich | Recruiting | München | 80336 | Germany |
|
| Department of Ophthalmology, Klinikum Stuttgart | Recruiting | Stuttgart | 70174 | Germany |
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| Centre for Ophthalmology, University Hospital Tuebingen | Recruiting | Tübingen | 72076 | Germany |
| Department of Ophthalmology, University Hospital Ulm | Not yet recruiting | Ulm | 89075 | Germany |
|
| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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