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Tests treatment safety and results for Geographic Atrophy Secondary to Age-related Macular...
Official title Safety and Clinical Applicability of Transcorneal Electrical Stimulation (TES) in Geographic Atrophy
ClinicalTrials.gov ID: NCT07531927
What this study is testing
- What it's testing
- 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).
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- 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
You likely can't join if
- History or presence of certain eye conditions (e.g. macular edema, abnormal blood vessel growth or related conditions, retinal detachment, blood...
- 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
See the full eligibility 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Hamburg, Germany
- München, Germany
- Stuttgart, Germany
- Tübingen, Germany
- Ulm, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hamburg, Germany; München, Germany; Stuttgart, Germany; Tübingen, Germany; Ulm, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.