NCT04295304

Brief Summary

The study objective is to demonstrate safety of the NR 600 System, and to evaluate the performance of the device in restoring visual activity of daily living in subjects with retinal degenerative diseases and severe visual impairment

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
3 countries

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2023

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2023

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

3.1 years

First QC Date

March 2, 2020

Last Update Submit

March 13, 2023

Conditions

Retinitis PigmentosaRetinal Degeneration

Outcome Measures

Primary Outcomes (1)

  • Safety endpoint

    Occurrence of serious adverse events related to the device and/or to the procedure

    within 9 months post implantation

Study Arms (1)

NR600 device implantation

EXPERIMENTAL

Retinal surgery and implantation of epi-retinal prosthesis

Device: Retinal surgery with implantation of epi-retinal device

Interventions

Retinal surgery with implantation of epi-retinal deviceDEVICE

Retinal surgery and implantation of epi-retinal prosthesis

NR600 device implantation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have confirmed diagnosis of end-stage hereditary outer retinal degeneration such as RP or cone-rod dystrophy
  • Visual acuity in both eyes from light perception to no light perception
  • Confirmed functional ganglion cells and optic nerve in the implanted eye
  • History of useful vision
  • Mentally competent

You may not qualify if:

  • Diseases or condition that affect retinal and or optic nerve function
  • Optic Nerve diseases
  • Diseases or conditions that, in the judgement of the surgeon, impede the ability to implant the device or would prevent the system from functioning
  • Dry eye
  • Pre-disposition to eye rubbing
  • Posterior pole severe staphyloma
  • Strabismus superior to 10 prismatic diopter
  • Severe nystagmus
  • Corneal endothelium density \< 1500 cells/mm2
  • Refractive error ≥±8 diopters spheric and 3.5 diopter cylindric
  • Currently pregnant (female subject) or inadequate contraceptive treatment in female subjects \<50 years of age.
  • Hyperthyroidism or hypersensitivity to iodine
  • Neurological and/or psychiatric diseases (e.g. M. Parkinson, epilepsy, depression)
  • Participation in another study with any investigational drug or device that may conflict with the objectives, follow-up or testing of this study
  • Conditions likely to limit life to less than 1 year from time of recruitment to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

UZ Ghent

Ghent, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Sourasky Medical Center

Tel Aviv, Israel

Location

San Raffaele

Milan, Italy

Location

Fondazione Policlinico A. Gemelli, IRCCS

Rome, Italy

Location

MeSH Terms

Conditions

Retinitis PigmentosaRetinal Degeneration

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal DystrophiesRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Weinberger Dov, Prof.

    Retinal surgeon

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2020

First Posted

March 4, 2020

Study Start

January 17, 2020

Primary Completion

March 9, 2023

Study Completion

March 12, 2023

Last Updated

March 15, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)BE(2)IL(2)