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

Sponsor

Retina Implant AG (Industry)

Overall Status

Completed

CT.gov ID

NCT01024803

Collaborator

(none)

Enrollment

Locations

100

Duration (Months)

6.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Retinitis Pigmentosa Retinal Degeneration	Device: Device name: "Retina Implant model Alpha". Surgical implantation of medical device into eye	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Study Start Date :

Dec 1, 2009

Actual Primary Completion Date :

Apr 1, 2017

Actual Study Completion Date :

Apr 1, 2018

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 78 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 and Locations

Locations

	Site	City	Country	Postal Code
1	Helmut Sachs, MD, PD	Dresden	Germany	01067
2	Johann Roider, MD, Prof.	Kiel	Germany	24105
3	Karl-Ulrich Bartz-Schmidt, MD, Prof.	Tuebingen	Germany	72076
4	Miklos Resch, MD, PhD	Budapest	Hungary	1083
5	Timothy L Jackson, MB.ChB, PhD, FRCOphth	London	United Kingdom	SE5 9RS
6	Robert MacLaren, MD, Prof., DPhil DipEd FRCOphth FRCS	Oxford	United Kingdom	OX3 9DU

Sponsors and Collaborators

Retina Implant AG

Investigators

Study Chair: Eberhart Zrenner, Prof. MD, Centre for Ophthalmology, Institute for Ophthalmic Research, University of Tuebingen, Germany
Principal Investigator: 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