Retinitis PigmentosaNCT00804102

Transcorneal Electrical Stimulation Therapy for Retinal Disease

A study testing Transcorneal Electrical Stimulation and DTL-electrode attached without energy in people with Retinitis Pigmentosa and Macula Off, run by Okuvision GmbH.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Transcorneal stimulation may enable neurons to survive degeneration processes via enhanced secretion of neurotrophic substances and direct stimulation of neurons. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Retinitis Pigmentosa, Macula Off, Primary Open Angle Glaucoma
What is being tested?: Transcorneal Electrical Stimulation and DTL-electrode attached without energy
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: No sites listed yet
Study dates: Jan 2008to Apr 2011
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Retinitis pigmentosa, Macula off, Primary open angle Glaucoma, Hereditary Macular Degeneration, Treated Retina detachment, Retinal Artery Occlusion, Retinal Vein Occlusion, Non-Arthritic-Anterior-Ischemic Optic-Neuropathy, Hereditary autosomal dominant Optic atrophy, dry Age-related Macular Degeneration, Ischemic Macula edema

Who cannot join

Severe other disease such as non-proliferative diabetic retinopathy, exudative Age-related Macular Degeneration
Age above 99 years

About this study

Official title: Transcorneal Electrical Stimulation Therapy for Retinal Disease - A Randomized, Single-blind Pilot Study

Transcorneal stimulation may enable neurons to survive degeneration processes via enhanced secretion of neurotrophic substances and direct stimulation of neurons.

Conditions: Retinitis Pigmentosa, Macula Off, Primary Open Angle Glaucoma, Hereditary Macular Degeneration, Treated Retina Detachment, Retinal Artery Occlusion
Being tested: Transcorneal Electrical Stimulation, DTL-electrode attached without energy
Keywords: Retinitis pigmentosa, Macula off, Primary open angle Glaucoma, Hereditary Macular Degeneration, Treated Retina detachment, Retinal Artery Occlusion, Retinal Vein Occlusion,, Non-Arthritic-Anterior-Ischemic Optic-Neuropathy, Hereditary autosomal dominant Optic atrophy, dry Age-related Macular Degeneration, Ischemic Macula edema
Medical subject headings: Retinitis Pigmentosa, Glaucoma, Open-Angle, Retinal Artery Occlusion, Retinal Vein Occlusion, Optic Atrophy, Autosomal Dominant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcorneal Electrical StimulationDevice
Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
DTL-electrode attached without energyDevice
DTL-electrode attached to patient eye receives no energy from neurostimulator. Treatment times remain the same as used for each treatment arm.

Study groups in NCT00804102
Study group	Role	What they receive
Retinitis pigmentosa	Active comparator	Not described Receives: Device: Transcorneal Electrical Stimulation
Macula off	Active comparator	condition after treatment of retinal detachment Receives: Device: Transcorneal Electrical Stimulation
Primary open angle Glaucoma	Active comparator	Not described Receives: Device: Transcorneal Electrical Stimulation
Hereditary Macular Degeneration	Active comparator	Not described Receives: Device: Transcorneal Electrical Stimulation
Treated Retina detachment	Active comparator	Not described Receives: Device: Transcorneal Electrical Stimulation
Retinal Artery Occlusion	Active comparator	Not described Receives: Device: Transcorneal Electrical Stimulation
Retinal Vein Occlusion	Active comparator	Not described Receives: Device: Transcorneal Electrical Stimulation
Non-Arteriitic-Anterior-Ischemic Optic-Neuropathy	Active comparator	Not described Receives: Device: Transcorneal Electrical Stimulation
Hereditary autosomal dominant Optic atrophy	Active comparator	Not described Receives: Device: Transcorneal Electrical Stimulation
dry Age-related Macular Degeneration	Active comparator	Not described Receives: Device: Transcorneal Electrical Stimulation
Ischemic Macula edema	Active comparator	Not described Receives: Device: Transcorneal Electrical Stimulation
Non-stimulated	Sham comparator	Not described Receives: Device: DTL-electrode attached without energy

What is being measured

The primary outcome is the main question the study is designed to answer.

enhanced field of vision, enhanced visual acuity, lower threshold for electrical evoked phosphenes
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Apr 2011

First posted8 Dec 2008 (estimated)
Study startJan 2008
Primary completionApr 2011
Study completionApr 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Retinitis PigmentosaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00804102
Sponsor's protocol ID: EST-2008
Status last verified: May 2012
First submitted: 5 Dec 2008
Last updated: 4 May 2012
Results posted: No
Data monitoring committee: Yes

Publications

Schatz A, Rock T, Naycheva L, Willmann G, Wilhelm B, Peters T, Bartz-Schmidt KU, Zrenner E, Messias A, Gekeler F. Transcorneal electrical stimulation for patients with retinitis pigmentosa: a prospective, randomized, sham-controlled exploratory study. Invest Ophthalmol Vis Sci. 2011 Jun 23;52(7):4485-96. doi: 10.1167/iovs.10-6932.
PubMed 21467183
Naycheva L, Schatz A, Rock T, Willmann G, Messias A, Bartz-Schmidt KU, Zrenner E, Gekeler F. Phosphene thresholds elicited by transcorneal electrical stimulation in healthy subjects and patients with retinal diseases. Invest Ophthalmol Vis Sci. 2012 Nov 1;53(12):7440-8. doi: 10.1167/iovs.12-9612.
PubMed 23049087

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingObservational study
Rate of Progression in USH2A-related Retinal Degeneration
Usher Syndrome, Type 2A, Retinitis Pigmentosa 39
Active, not recruitingObservational study
Rate of Progression in EYS Related Retinal Degeneration
Retinitis Pigmentosa, Eye Diseases
RecruitingObservational study
Universal Rare Gene Study: A Registry and Natural History Study of Retinal Dystrophies Associated With Rare Disease-Causing Genetic Variants
Inherited Retinal Degeneration, Retinitis Pigmentosa
RecruitingObservational study
Rod and Cone Mediated Function in Retinal Disease
Retinal Degeneration, Retinitis Pigmentosa
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders

All Retinitis Pigmentosa trials

Study at a glance

From the registry record, last updated by the sponsor on 4 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Transcorneal Electrical Stimulation Therapy for Retinal Disease - A Randomized, Single-blind Pilot Study
ClinicalTrials.gov ID: NCT00804102
Acronym / sponsor ID: EST-2008
Conditions: Retinitis Pigmentosa, Macula Off, Primary Open Angle Glaucoma, Hereditary Macular Degeneration, Treated Retina Detachment, Retinal Artery Occlusion
Keywords: Retinitis pigmentosa, Macula off, Primary open angle Glaucoma, Hereditary Macular Degeneration, Treated Retina detachment, Retinal Artery Occlusion, Retinal Vein Occlusion,, Non-Arthritic-Anterior-Ischemic Optic-Neuropathy
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Okuvision GmbHIndustry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 8 Dec 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Transcorneal stimulation may enable neurons to survive degeneration processes via enhanced secretion of neurotrophic substances and direct stimulation of neurons.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 12

Arm	Type	Receives
Retinitis pigmentosa	Active comparator	Device: Transcorneal Electrical Stimulation
Macula off	Active comparator	Device: Transcorneal Electrical Stimulationcondition after treatment of retinal detachment
Primary open angle Glaucoma	Active comparator	Device: Transcorneal Electrical Stimulation
Hereditary Macular Degeneration	Active comparator	Device: Transcorneal Electrical Stimulation
Treated Retina detachment	Active comparator	Device: Transcorneal Electrical Stimulation
Retinal Artery Occlusion	Active comparator	Device: Transcorneal Electrical Stimulation
Retinal Vein Occlusion	Active comparator	Device: Transcorneal Electrical Stimulation
Non-Arteriitic-Anterior-Ischemic Optic-Neuropathy	Active comparator	Device: Transcorneal Electrical Stimulation
Hereditary autosomal dominant Optic atrophy	Active comparator	Device: Transcorneal Electrical Stimulation
dry Age-related Macular Degeneration	Active comparator	Device: Transcorneal Electrical Stimulation
Ischemic Macula edema	Active comparator	Device: Transcorneal Electrical Stimulation
Non-stimulated	Sham comparator	Device: DTL-electrode attached without energy

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Retinitis pigmentosa, Macula off, Primary open angle Glaucoma, Hereditary Macular Degeneration, Treated Retina detachment, Retinal Artery Occlusion, Retinal Vein Occlusion, Non-Arthritic-Anterior-Ischemic Optic-Neuropathy, Hereditary autosomal dominant Optic atrophy, dry Age-related Macular Degeneration, Ischemic Macula edema

Key exclusion criteria (2 listed)

Severe other disease such as non-proliferative diabetic retinopathy, exudative Age-related Macular Degeneration
Age above 99 years

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transcorneal Electrical StimulationNeurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.	Device	Hereditary Macular Degeneration, Hereditary autosomal dominant Optic atrophy, Ischemic Macula edema, Macula off, Non-Arteriitic-Anterior-Ischemic Optic-Neuropathy, Primary open angle Glaucoma, Retinal Artery Occlusion, Retinal Vein Occlusion, Retinitis pigmentosa, Treated Retina detachment, dry Age-related Macular Degeneration
DTL-electrode attached without energyDTL-electrode attached to patient eye receives no energy from neurostimulator. Treatment times remain the same as used for each treatment arm.	Device	Non-stimulated

Primary outcome

enhanced field of vision, enhanced visual acuity, lower threshold for electrical evoked phosphenes
Time frame: 3 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2012.
Results publication: PubMed 21467183Schatz A, Rock T, Naycheva L, Willmann G, Wilhelm B, Peters T, Bartz-Schmidt KU, Zrenner E, Messias A, Gekeler F. Transcorneal electrical stimulation for patients with retinitis pigmentosa: a prospective, randomized, sham-controlled exploratory study. Invest Ophthalmol Vis Sci. 2011 Jun 23;52(7):4485-96. doi: 10.1167/iovs.10-6932.
Derived from this study: PubMed 23049087Naycheva L, Schatz A, Rock T, Willmann G, Messias A, Bartz-Schmidt KU, Zrenner E, Gekeler F. Phosphene thresholds elicited by transcorneal electrical stimulation in healthy subjects and patients with retinal diseases. Invest Ophthalmol Vis Sci. 2012 Nov 1;53(12):7440-8. doi: 10.1167/iovs.12-9612.

Related trials for Retinitis Pigmentosa

Active, not recruitingObservational study
Rate of Progression in USH2A-related Retinal Degeneration
Usher Syndrome, Type 2A, Retinitis Pigmentosa 39
Active, not recruitingObservational study
Rate of Progression in EYS Related Retinal Degeneration
Retinitis Pigmentosa, Eye Diseases
RecruitingObservational study
Universal Rare Gene Study: A Registry and Natural History Study of Retinal Dystrophies Associated With Rare Disease-Causing Genetic Variants
Inherited Retinal Degeneration, Retinitis Pigmentosa
RecruitingObservational study
Rod and Cone Mediated Function in Retinal Disease
Retinal Degeneration, Retinitis Pigmentosa
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Florian Gekeler, MD, Prof principal investigator

University-Eye-Hospital, Centre for Ophthalmology, D-72076 Tübingen, Germany

Questions about this trial

What is this clinical trial studying?

A study testing Transcorneal Electrical Stimulation and DTL-electrode attached without energy in people with Retinitis Pigmentosa and Macula Off, run by Okuvision GmbH.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2012. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

enhanced field of vision, enhanced visual acuity, lower threshold for electrical evoked phosphenes (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00804102, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2012.