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

Safety & Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients: A Prospective Mono- & Multicenter Clinical Study Based on Randomized Intra-individual Implant Activation in Degenerative Retinal Disease Patients.

Patients who are legally blind, caused by retinal degeneration of photoreceptor rods & cones (e.g. Retinitis pigmentosa), receive a subretinal implant to restore vision partially.

Study Overview

• Status: Completed
• Conditions: Retinal Degeneration; Retinitis Pigmentosa
• Intervention / Treatment: Procedure: surgical implantation of subretinal device; Procedure: surgical implantation of subretinal device

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Cyberport
    • Hong Kong, Cyberport, Hong Kong, 100
      • Ophthalmology Eye Institute, University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 (impaired light localization or worse).
• 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

Exclusion Criteria:

• Period of appropriate visual functions < 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intra-individual implant ON; intra-individual implant activation	Procedure: surgical implantation of subretinal device; surgical implantation of subretinal device; Other Names: Retinal implant, subretinal implant; Procedure: surgical implantation of subretinal device; intra-individual implant OFF; Other Names: Retinal implant, subretinal implant
Placebo Comparator: intra-individual implant OFF; intra-individual implant deactivation	Procedure: surgical implantation of subretinal device; surgical implantation of subretinal device; Other Names: Retinal implant, subretinal implant; Procedure: surgical implantation of subretinal device; intra-individual implant OFF; Other Names: Retinal implant, subretinal implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	treatment shows no permanent damage of function and structures that have been functional before surgery and no permanent damage to health and/or well being of patients	1 year
Efficacy	Activities of Daily Living & Mobility are significantly improved with implant-ON versus OFF, as shown via tests: Activities of Daily Living tasks or; Recognition tasks or; Mobility or; a combination of the above	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Patient long term safety: stability of implant function; stability of body structure & function related to implant system	1 year
Efficacy	Visual Acuity / Light-perception and/or Object-recognition are significantly improved with implant-ON versus OFF as shown via: FrACT or; BaLM or; Grating test (e.g. BaGA) and/or Quality of life; Quality of life (questionnaire) or; a combination of the above	1 year

Collaborators and Investigators

• Sponsor: Retina Implant AG
• Investigators: Principal Investigator: David Wong, Prof., MD, Chair Professor in Ophthalmology Eye Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: December 15, 2011
• First Submitted That Met QC Criteria: December 19, 2011
• First Posted (Estimate): December 22, 2011

Study Record Updates

• Last Update Posted (Actual): March 29, 2017
• Last Update Submitted That Met QC Criteria: March 28, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Hereditary retinal; degeneration outer; retinal layers; photoreceptor rods cones; Retinitis pigmentosa; blindness; reading ability; retina implant; subretinal
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Retinal Dystrophies; Retinitis; Retinitis Pigmentosa; Retinal Degeneration
• Other Study ID Numbers: HKCTR-1198; RI-MC-CT-2009 (Clinicaltrials.gov)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No