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

NCT01024803 | Completed DMC

• 1 other identifier: RI-MC-CT-2009
• Study Type: interventional
• Target: 39
• Locations: 3 countries
• Sites: 6

Brief 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.

Conditions

Retinitis Pigmentosa; Retinal Degeneration

Keywords

Retina implant, Subretinal; Legal blindness; Genetic Diseases, Inborn; Eye Diseases; Retinitis Pigmentosa; Retinitis; Retinal Degeneration; Eye Diseases, Hereditary; Retinal Diseases

Outcome Measures

Primary Outcomes (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.

  every 3 months for a period of one year

Secondary Outcomes (2)

• 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.

  every 3 months for a period of one year

• Patient long term safety and stability of implant function

  every 3 months for a period of one year

Interventions

Device name: "Retina Implant model Alpha". Surgical implantation of medical device into eye DEVICE

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.

Also known as: retinal implant, bionic eye, artificial vision, artificial eye, restoration of vision, eye chip, vision prosthesis, eye implant, retinal prosthesis

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Retina Implant AG: lead

Study Sites (6)

Helmut Sachs, MD, PD

Dresden, 01067, Germany

Location

Johann Roider, MD, Prof.

Kiel, 24105, Germany

Location

Karl-Ulrich Bartz-Schmidt, MD, Prof.

Tübingen, 72076, Germany

Location

Miklos Resch, MD, PhD

Budapest, 1083, Hungary

Location

Timothy L Jackson, MB.ChB, PhD, FRCOphth

London, SE5 9RS, United Kingdom

Location

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

Oxford, OX3 9DU, United Kingdom

Location

Related Publications (12)

• 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.

  PMID: 26783453 BACKGROUND

• 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.

  PMID: 25906684 BACKGROUND

• 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.

  PMID: 23410193 BACKGROUND

• 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.

  PMID: 23427175 BACKGROUND

• 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.

  PMID: 25812924 RESULT

• 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.

  PMID: 25219982 RESULT

• 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.

  PMID: 24150759 RESULT

• 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.

  PMID: 28878616 RESULT

• 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.

  PMID: 32343050 DERIVED

• 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.

  PMID: 30816625 DERIVED

• 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.

  PMID: 25298411 DERIVED

• 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.

  PMID: 22562517 DERIVED

MeSH Terms

Conditions

Retinitis Pigmentosa; Retinal Degeneration; Blindness; Genetic Diseases, Inborn; Eye Diseases; Retinitis; Eye Diseases, Hereditary; Retinal Diseases

Interventions

Visual Prosthesis; Eye, Artificial

Condition Hierarchy (Ancestors)

Retinal Dystrophies; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Eberhart Zrenner, Prof. MD

  Centre for Ophthalmology, Institute for Ophthalmic Research, University of Tuebingen, Germany

  STUDY CHAIR

• Karl-Ulrich Bartz-Schmidt, Prof. MD

  University Eye Hospital Tuebingen, Germany

  PRINCIPAL INVESTIGATOR

• Timothy L Jackson, PhD FRCOphth

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

• János Németh, Prof. MD PhD

  Department of Ophthalmology Semmelweis University Budapest

  PRINCIPAL INVESTIGATOR

• Robert E MacLaren, Prof. DPhil

  Department of Ophthalmology, John Radcliffe Hospital, Oxford, UK

  PRINCIPAL INVESTIGATOR

• Johann Roider, Prof. MD

  University Eye Hospital, Kiel, Germany

  PRINCIPAL INVESTIGATOR

• Helmut Sachs, PD, MD

  Eye Hospital Dresden-Friedrichstadt, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2009
• First Posted: December 3, 2009
• Study Start: December 1, 2009
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2018
• Last Updated: September 5, 2018

Record last verified: 2018-09

Locations

DE (3); HU (1); GB (2)