AzTrials
AzTrials

Retinitis PigmentosaNCT01024803

Safety and Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients

A study testing Device name: "Retina Implant model Alpha". Surgical implantation of medical device into eye in people with Retinitis Pigmentosa and Retinal Degeneration, run by Retina Implant AG at 6 sites in 3 countries.

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

Patients suffering from hereditary retinal degeneration receive a retinal implant to restore sight. Subretinal implant "ON" results in significant visual acuity improvement, when compared to "OFF" condition. Read more about this study

Who is it for?
Ages 18 to 78 years
Conditions the study is for
Retinitis Pigmentosa, Retinal Degeneration
What is being tested?
Device name: "Retina Implant model Alpha". Surgical implantation of medical device into eye
Type of treatment
Medical device
How many people
39 participants
Where
6 sitesin 3 countries
Study dates
Dec 2009to Apr 2018
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 to 78 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Hereditary retinal degeneration of the outer retinal layers i.e. photoreceptor rods \& cones.
  • Pseudophakia
  • Angiography shows retinal vessels adequately perfused, despite pathological RP condition.
  • Age between 18 and 78 years.
  • Blindness (at least monocular) i.e. visual functions not appropriate for localization of objects, self sustained navigation and orientation.
  • Ability to read normal print in earlier life, optically corrected without magnifying glass.
  • Willing and able to give written informed consent in accordance to EN ISO 14155 (section 6.7) and local legislation prior to participation in the study. Able to perform the study during the full time period of one year for Module-2.

Who cannot join

  • Period of appropriate visual functions approx. 12 years / lifetime.
  • Optical Coherence Tomography (OCT) shows significant retina edema \&/or scar tissue within target region for implant.
  • Retina detected as too thin to expect required rest-functionality of inner retina as shown via Optical Coherence Tomography (OCT).
  • Lack of inner-retinal function, as determined by Electrically Evoked Phosphenes (EEP).
  • Heavy clumped pigmentation at posterior pole
  • Any other ophthalmologic disease with relevant effect upon visual function (e.g. glaucoma, optic neuropathies, trauma, diabetic retinopathy, retinal detachment).
Show all 12Show fewer
  • Amblyopia reported earlier in life on eye to be implanted
  • Systemic diseases that might imply considerable risks with regard to the surgical interventions and anaesthesia (e.g. cardiovascular/ pulmonary diseases, severe metabolic diseases).
  • Neurological and/or psychiatric diseases (e.g. M. Parkinson, epilepsy, depression).
  • Hyperthyroidism or hypersensitivity to iodine
  • Women who are pregnant or nursing, or women of childbearing potential who are not willing to use a medically acceptable means of birth control for the duration of the study, or women unwilling to perform a pregnancy test before entering the study.
  • Participation in another interventional clinical trial within the past 30 days.

Trial locations and contacts

6 sites in 3 countries.

6 sites in 3 countries

Germany3 sites

  • Helmut Sachs, MD, PD

    Dresden, 01067

  • Johann Roider, MD, Prof.

    Kiel, 24105

  • Karl-Ulrich Bartz-Schmidt, MD, Prof.

    Tübingen, 72076

Other trials in Germany

United Kingdom2 sites

  • Timothy L Jackson, MB.ChB, PhD, FRCOphth

    London, SE5 9RS

  • Robert MacLaren, MD, Prof., DPhil DipEd FRCOphth FRCS

    Oxford, OX3 9DU

Other trials in United Kingdom

Hungary1 site

  • Miklos Resch, MD, PhD

    Budapest, 1083

Other trials in Hungary

About this study

Official title: Safety and Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients: A Prospective Multicenter Clinical Study Based on Randomized Intra-individual Implant Activation in Patients With Degenerative Retinal Diseases

Patients suffering from hereditary retinal degeneration receive a retinal implant to restore sight.

Subretinal implant "ON" results in significant visual acuity improvement, when compared to "OFF" condition.

Being tested
Device name: "Retina Implant model Alpha". Surgical implantation of medical device into eye
Keywords
Retina implant, Subretinal, Legal blindness, Genetic Diseases, Inborn, Eye Diseases, Retinitis Pigmentosa, Retinitis, Retinal Degeneration, Eye Diseases, Hereditary, Retinal Diseases
Medical subject headings
Retinitis Pigmentosa, Retinal Degeneration, Blindness, Genetic Diseases, Inborn, Eye Diseases, Retinitis, Eye Diseases, Hereditary, Retinal Diseases

What participants receive

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

  • Device name: "Retina Implant model Alpha". Surgical implantation of medical device into eyeDevice

    Also called retinal implant, bionic eye, artificial vision, artificial eye

    Surgical implantation of medical device named "Retina Implant" into eye to restore vision partially.

    Randomized intra-individual implant activation in patient under test conditions such as: FrACT, BaLM, BaGA, maze, ADL.

What is being measured

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

  1. Activities of daily living and mobility significantly improve with implant-ON shown via activities of daily living tasks, recognition tasks, mobility, or a combination thereof.

    Measured: every 3 months for a period of one year

Secondary outcomes (2)

  1. Visual acuity/light-perception and/or object-recognition are significantly improved with implant-ON versus OFF as shown via: FrACT/BaLM/BaGA/VFQ-25 or a combination thereof.

    Measured: every 3 months for a period of one year

  2. Patient long term safety and stability of implant function

    Measured: every 3 months for a period of one year

Timeline

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

  1. First posted3 Dec 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionApr 2017
  4. Study completionApr 2018

Resources

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
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01024803
Sponsor's protocol ID
RI-MC-CT-2009
Status last verified
Sep 2018
First submitted
26 Nov 2009
Last updated
5 Sep 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Koitschev A, Stingl K, Bartz-Schmidt KU, Braun A, Gekeler F, Greppmaier U, Sachs H, Peters T, Wilhelm B, Zrenner E, Besch D. Extraocular Surgical Approach for Placement of Subretinal Implants in Blind Patients: Lessons from Cochlear-Implants. J Ophthalmol. 2015;2015:842518. doi: 10.1155/2015/842518. Epub 2015 Dec 10.

    PubMed 26783453

  • Hafed ZM, Stingl K, Bartz-Schmidt KU, Gekeler F, Zrenner E. Oculomotor behavior of blind patients seeing with a subretinal visual implant. Vision Res. 2016 Jan;118:119-31. doi: 10.1016/j.visres.2015.04.006. Epub 2015 Apr 20.

    PubMed 25906684

  • Stingl K, Gekeler F, Bartz-Schmidt KU, Kogel A, Zrenner E, Gelisken F. Fluorescein angiographic findings in eyes of patients with a subretinal electronic implant. Curr Eye Res. 2013 May;38(5):588-96. doi: 10.3109/02713683.2013.767349. Epub 2013 Feb 14.

    PubMed 23410193

  • Stingl K, Bartz-Schmidt KU, Besch D, Braun A, Bruckmann A, Gekeler F, Greppmaier U, Hipp S, Hortdorfer G, Kernstock C, Koitschev A, Kusnyerik A, Sachs H, Schatz A, Stingl KT, Peters T, Wilhelm B, Zrenner E. Artificial vision with wirelessly powered subretinal electronic implant alpha-IMS. Proc Biol Sci. 2013 Feb 20;280(1757):20130077. doi: 10.1098/rspb.2013.0077. Print 2013 Apr 22.

    PubMed 23427175

  • Stingl K, Bartz-Schmidt KU, Besch D, Chee CK, Cottriall CL, Gekeler F, Groppe M, Jackson TL, MacLaren RE, Koitschev A, Kusnyerik A, Neffendorf J, Nemeth J, Naeem MA, Peters T, Ramsden JD, Sachs H, Simpson A, Singh MS, Wilhelm B, Wong D, Zrenner E. Subretinal Visual Implant Alpha IMS--Clinical trial interim report. Vision Res. 2015 Jun;111(Pt B):149-60. doi: 10.1016/j.visres.2015.03.001. Epub 2015 Mar 23.

    PubMed 25812924

  • Kitiratschky VB, Stingl K, Wilhelm B, Peters T, Besch D, Sachs H, Gekeler F, Bartz-Schmidt KU, Zrenner E. Safety evaluation of "retina implant alpha IMS"--a prospective clinical trial. Graefes Arch Clin Exp Ophthalmol. 2015 Mar;253(3):381-7. doi: 10.1007/s00417-014-2797-x. Epub 2014 Sep 16.

    PubMed 25219982

  • Stingl K, Bartz-Schmidt KU, Gekeler F, Kusnyerik A, Sachs H, Zrenner E. Functional outcome in subretinal electronic implants depends on foveal eccentricity. Invest Ophthalmol Vis Sci. 2013 Nov 19;54(12):7658-65. doi: 10.1167/iovs.13-12835.

    PubMed 24150759

  • Stingl K, Schippert R, Bartz-Schmidt KU, Besch D, Cottriall CL, Edwards TL, Gekeler F, Greppmaier U, Kiel K, Koitschev A, Kuhlewein L, MacLaren RE, Ramsden JD, Roider J, Rothermel A, Sachs H, Schroder GS, Tode J, Troelenberg N, Zrenner E. Interim Results of a Multicenter Trial with the New Electronic Subretinal Implant Alpha AMS in 15 Patients Blind from Inherited Retinal Degenerations. Front Neurosci. 2017 Aug 23;11:445. doi: 10.3389/fnins.2017.00445. eCollection 2017.

    PubMed 28878616

  • Cehajic Kapetanovic J, Troelenberg N, Edwards TL, Xue K, Ramsden JD, Stett A, Zrenner E, MacLaren RE. Highest reported visual acuity after electronic retinal implantation. Acta Ophthalmol. 2020 Nov;98(7):736-740. doi: 10.1111/aos.14443. Epub 2020 Apr 28.

    PubMed 32343050

  • Kuehlewein L, Troelenberg N, Stingl K, Schleehauf S, Kusnyerik A, Jackson TL, MacLaren RE, Chee C, Roider J, Wilhelm B, Gekeler F, Bartz-Schmidt KU, Zrenner E, Stingl K. Changes in microchip position after implantation of a subretinal vision prosthesis in humans. Acta Ophthalmol. 2019 Sep;97(6):e871-e876. doi: 10.1111/aos.14077. Epub 2019 Feb 28.

    PubMed 30816625

  • Rock T, Bartz-Schmidt KU, Bramkamp M, Rock D. Influence of axial length on thickness measurements using spectral-domain optical coherence tomography. Invest Ophthalmol Vis Sci. 2014 Oct 8;55(11):7494-8. doi: 10.1167/iovs.14-14043.

    PubMed 25298411

  • Kusnyerik A, Greppmaier U, Wilke R, Gekeler F, Wilhelm B, Sachs HG, Bartz-Schmidt KU, Klose U, Stingl K, Resch MD, Hekmat A, Bruckmann A, Karacs K, Nemeth J, Suveges I, Zrenner E. Positioning of electronic subretinal implants in blind retinitis pigmentosa patients through multimodal assessment of retinal structures. Invest Ophthalmol Vis Sci. 2012 Jun 20;53(7):3748-55. doi: 10.1167/iovs.11-9409.

    PubMed 22562517

Questions about this trial

What is this clinical trial studying?

A study testing Device name: "Retina Implant model Alpha". Surgical implantation of medical device into eye in people with Retinitis Pigmentosa and Retinal Degeneration, run by Retina Implant AG at 6 sites in 3 countries.

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 7 inclusion and 12 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 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany, United Kingdom, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

Activities of daily living and mobility significantly improve with implant-ON shown via activities of daily living tasks, recognition tasks, mobility, or a combination thereof. (time frame: every 3 months for a period of one year). 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 NCT01024803, which also lists 12 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 5 Sep 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in