Geographic Atrophy Secondary to Age-related Macular Degeneration
Conditions
Keywords
TES, TcES, OkuStim, OkuStim 2, Okuvision, Electrical Stimulation, Transcorneal Electrical Stimulation, Geographic Atrophy, AMD
Brief summary
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: * TES-treatment with a rectangular stimulus * TES-treatment with a repetitive ramp stimulus * Placebo (sham) treatment Participants will apply the therapy at home, once a week for 30 minutes each over a duration of 1 year.
Detailed description
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: * TES-treatment with a rectangular stimulus * TES-treatment with a repetitive ramp stimulus * Placebo (sham) treatment 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).
Interventions
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.
Sponsors
Okuvision GmbH
CONVIDIA clinical research GmbH
Nubilaria Srl
TentaConsult Pharma & Med GmbH
Department of Ophthalmology, University Hospital Ulm, Germany
Department of Ophthalmology, Klinikum Stuttgart, Germany
Centre for Ophthalmology, University Hospital Tuebingen, Germany
Universitätsklinikum Hamburg-Eppendorf
Department of Ophthalmology, Ludwig-Maximilians-University Munich, Germany
Steinbeis-Forschungszentrum, GRADE Reading Center
Clinical Study Core Unit SZB, Studienzentrum Bonn, University Hospital Bonn, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Patients are assigned 1:1:1 to one of three different groups: Sham group (sham treatment), biphasic rectangular pulses, or repetitive ramp stimulus.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Willing and able to understand the study and provide informed consent * 60 years of age or older * Diagnosis of geographic atrophy due to age-related macular degeneration confirmed by imaging * The affected area in the eye must be within a defined size range and clearly visible on imaging * Eye conditions must allow for good-quality images and reliable measurements * Must have a minimum level of visual acuity * Women of childbearing potential must have a negative pregnancy test, and must agree to use effective contraception during the study (women who are postmenopausal or surgically sterile are not subject to pregnancy-related requirements)
Exclusion criteria
* History or presence of certain eye conditions (e.g. macular edema, abnormal blood vessel growth or related conditions, retinal detachment, blood vessel blockage) in the study eye * Previous major eye surgeries (including retinal surgery or vitrectomy) * Previous laser treatment or injections in the study eye * Any other eye condition that could interfere with vision tests, imaging or study results * Planned eye surgery during the study period * Recent treatment with investigational drugs for geographic atrophy * Presence of active medical implants * Serious or uncontrolled systemic diseases, history of epilepsy or poor general health or conditions affecting the ability to follow study procedures * Participation in another clinical study recently or at the same time * Breastfeeding, relevant allergies (e.g. to silver), or heavy smoking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of TES therapy in GA | From enrolment until the end of the study for the individual participant at 52 weeks | Determined by the nature and number of device-related adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effects of TES therapy with two different stimulus waveforms on the progression of GA lesion areas | At 12 months and at timepoints in between (4, 17 and 34 weeks after the baseline-visit) compared to baseline | Assessed by fundus autofluorescence (FAF) in combination with optical coherence tomography (OCT) |
| Effects of TES therapy with two different stimulus waveforms on structural changes in retinal layers | At 12 months and at timepoints in between (4, 17 and 34 weeks after the baseline-visit) compared to baseline | Assessed by OCT |
| Effects of TES therapy with two different stimulus waveforms on functional changes in the border zone of GA areas | At 12 months and at timepoints in between (17 and 34 weeks after the baseline-visit) compared to baseline | Assessed by patient-tailored microperimetry (mMAIA) |
| Effects of TES therapy with two different stimulus waveforms on visual acuity under normal luminance conditions | At 12 months and at timepoints in between (4, 17 and 34 weeks after the baseline-visit) compared to baseline | Assessed with ETDRS chart |
| Effects of TES therapy with two different stimulus waveforms on visual acuity under low-luminance conditions | At 12 months and at timepoints in between (4, 17 and 34 weeks after the baseline-visit) compared to baseline | Assessed with ETDRS chart and a neutral density filter |
| Effects of TES therapy with two different stimulus waveforms on patient-reported outcomes regarding the impact on daily life | At 12 months compared to baseline | Assessed with the Vision Impairment in Low Luminance (VILL-33) questionnaire |
| 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 | At 12 months compared to baseline | Assessed with a custom-made questionnaire |
Countries
Germany
Contacts
CONTACTRuth Schippert, PhD
PRINCIPAL_INVESTIGATORFlorian Gekeler, Prof. Dr.
Department of Ophthalmology, Klinikum Stuttgart, Germany
Outcome results
None listed