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

Not Applicable

Completed

• Conditions: Retinal Degeneration; Retinitis Pigmentosa

• Registration Number: NCT01024803
• Lead Sponsor: Retina Implant AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-26
• Study Start: 2009-12
• Study First Submitted QC: 2009-12-02
• Study First Posted: 2009-12-03
• Primary Completion: 2017-04
• Study Completion: 2018-04
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-03
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (6)

Helmut Sachs, MD, PD; 🇩🇪 Dresden, Germany

Johann Roider, MD, Prof.; 🇩🇪 Kiel, Germany

Karl-Ulrich Bartz-Schmidt, MD, Prof.; 🇩🇪 Tuebingen, Germany

Timothy L Jackson, MB.ChB, PhD, FRCOphth; 🇬🇧 London, United Kingdom

Robert MacLaren, MD, Prof., DPhil DipEd FRCOphth FRCS; 🇬🇧 Oxford, United Kingdom

Miklos Resch, MD, PhD; 🇭🇺 Budapest, Hungary