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

NCT01497379 | Completed DMC

• 2 other identifiers: HKCTR-1198RI-MC-CT-2009
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Retinal Degeneration; Retinitis Pigmentosa

Keywords

Hereditary retinal; degeneration outer; retinal layers; photoreceptor rods cones; Retinitis pigmentosa; blindness; reading ability; retina implant; subretinal

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Safety

  1 year

• Efficacy

  1 year

Study Arms (2)

intra-individual implant ON

EXPERIMENTAL

intra-individual implant activation

Procedure: surgical implantation of subretinal device

intra-individual implant OFF

PLACEBO COMPARATOR

intra-individual implant deactivation

Procedure: surgical implantation of subretinal device

Interventions

surgical implantation of subretinal device PROCEDURE

surgical implantation of subretinal device

Also known as: Retinal implant, subretinal implant

intra-individual implant ON

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Retina Implant AG: lead

Study Sites (1)

Ophthalmology Eye Institute, University of Hong Kong

Hong Kong, Cyberport, 100, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 25812924 RESULT

Related Links

• Hong Kong clinical trials registry

MeSH Terms

Conditions

Retinal Degeneration; Retinitis Pigmentosa; Blindness

Interventions

Retinaldehyde

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Diseases; Retinal Dystrophies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aldehydes; Organic Chemicals; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Officials

• David Wong, Prof., MD

  Chair Professor in Ophthalmology Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2011
• First Posted: December 22, 2011
• Study Start: October 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2015
• Last Updated: March 29, 2017

Record last verified: 2017-03

Locations

HK (1)