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

Retinitis Pigmentosa Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01024803
• Other study ID #: RI-MC-CT-2009
• Status: Completed
• Phase: N/A
• Start date: December 2009
• Est. completion date: April 2018

Study information

• Verified date: September 2018
• Source: Retina Implant AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: April 2018
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 78 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Retinal Degeneration
• Retinal Diseases
• Retinitis
• Retinitis Pigmentosa

Intervention

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

Locations

Country	Name	City	State
Germany	Helmut Sachs, MD, PD	Dresden
Germany	Johann Roider, MD, Prof.	Kiel
Germany	Karl-Ulrich Bartz-Schmidt, MD, Prof.	Tuebingen
Hungary	Miklos Resch, MD, PhD	Budapest
United Kingdom	Timothy L Jackson, MB.ChB, PhD, FRCOphth	London
United Kingdom	Robert MacLaren, MD, Prof., DPhil DipEd FRCOphth FRCS	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Retina Implant AG

Countries where clinical trial is conducted

Germany,  Hungary,  United Kingdom, 

References & Publications (8)

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. — View Citation

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/ — View Citation

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. — View Citation

Stingl K, Bartz-Schmidt KU, Besch D, Braun A, Bruckmann A, Gekeler F, Greppmaier U, Hipp S, Hörtdörfer 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. — View Citation

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. Subreti — View Citation

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. — View Citation

Stingl K, Gekeler F, Bartz-Schmidt KU, Kögel 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. — View Citation

Stingl K, Schippert R, Bartz-Schmidt KU, Besch D, Cottriall CL, Edwards TL, Gekeler F, Greppmaier U, Kiel K, Koitschev A, Kühlewein L, MacLaren RE, Ramsden JD, Roider J, Rothermel A, Sachs H, Schröder GS, Tode J, Troelenberg N, Zrenner E. Interim Results — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Patient long term safety and stability of implant function		every 3 months for a period of one year