Safety and Efficacy of Subretinal Implants for Partial Re... | NCT01024803

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.		retinal implant bionic eye artificial vision artificial eye restoration of vision eye chip vision prosthesis eye implant retinal prosthesis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

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.

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
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

Facility	Status	City	State	ZIP	Country	Contacts
Helmut Sachs, MD, PD		Dresden		01067	Germany
Johann Roider, MD, Prof.

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26783453	Background	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.
25906684

ID	Term
D058499	Retinal Dystrophies
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D014786	Vision Disorders
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D057488	Visual Prosthesis
D005137	Eye, Artificial

ID	Term
D019736	Prostheses and Implants
D004864	Equipment and Supplies