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

Retinitis Pigmentosa Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01497379
• Other study ID #: HKCTR-1198
• Secondary ID: RI-MC-CT-2009
• Status: Completed
• Phase: N/A
• First received: December 15, 2011
• Last updated: March 28, 2017
• Start date: October 2011
• Est. completion date: January 2015

Study information

• Verified date: March 2017
• Source: Retina Implant AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: January 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 78 Years

Eligibility

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.

Related Conditions & MeSH terms

• Retinal Degeneration
• Retinitis
• Retinitis Pigmentosa

Intervention

Procedure:
• surgical implantation of subretinal device
surgical implantation of subretinal device
• surgical implantation of subretinal device
intra-individual implant OFF

Locations

Country	Name	City	State
Hong Kong	Ophthalmology Eye Institute, University of Hong Kong	Hong Kong	Cyberport

Sponsors (1)

Lead Sponsor	Collaborator
Retina Implant AG

Country where clinical trial is conducted

Hong Kong, 

References & 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. Subreti — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Safety	Patient long term safety: stability of implant function; stability of body structure & function related to implant system	1 year
Secondary	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

External Links

•   Hong Kong clinical trials registry