NCT00407602

Brief Summary

Investigational Phase of the Study: The objective of this feasibility study is to evaluate the safety and utility of the Argus II Retinal Stimulation System in providing visual function to blind subjects with retinitis pigmentosa. Post-Approval Phase of the Study: To collect post-approval data in order to monitor the ongoing safety and reliability of the Argus II System

Trial Health

93
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable

Geographic Reach
5 countries

12 active sites

Status
completed

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

September 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2006

Completed
13.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
2 years until next milestone

Results Posted

Study results publicly available

December 30, 2021

Completed
Last Updated

January 20, 2022

Status Verified

January 1, 2022

Enrollment Period

13.3 years

First QC Date

December 1, 2006

Results QC Date

September 24, 2019

Last Update Submit

January 11, 2022

Conditions

Retinitis Pigmentosa

Keywords

retinitis pigmentosadeviceretinal implantretinal prosthesisRPouter retinal degeneration

Outcome Measures

Primary Outcomes (2)

  • Visual Acuity

    Grating Visual Acuity is performed at Baseline and at various timepoints throughout the study. As of the 10 year final testing, the total number of subjects that were able to score on the logMAR scale are indicated below. The device has a scale from 1.6 to 2.9 logMAR. Maximum likelihood estimation of visual acuity is based on BEST-PEST algorithm.

    10 years

  • Number of Participants With Adverse Events

    Evaluate ocular adverse events reported for all subjects from day of implant through 10 years of study participation

    10 years

Secondary Outcomes (6)

  • Massof Activity Inventory

    3 years

  • Quality of Life - Tasks for Daily Living

    3 years

  • Orientation and Mobility

    5 years

  • Visual Function

    10 years

  • Stability of Implant - 5 Years Post Implant

    5 years

  • +1 more secondary outcomes

Study Arms (1)

Implant of Argus II Retinal Prosthesis

OTHER

This is a single group study where the status and performance of the implanted eye prior to surgery serves as the comparator.

Device: Implant of Argus II Retinal Prosthesis

Interventions

Implant of Argus II Retinal ProsthesisDEVICE

epiretinal implantation of device

Implant of Argus II Retinal Prosthesis

Eligibility Criteria

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

You may qualify if:

  • A confirmed history of retinitis pigmentosa (all centers) or outer retinal degeneration (France, U.K., Switzerland, Mexico only) with remaining visual acuity of bare light perception (all centers) or 2.3 logMAR (France, U.K., Switzerland, Mexico only) or worse in both eyes.
  • Functional ganglion cells and optic nerve as determined by a measurable electrically evoked response or documented light perception.
  • A history of former useful form vision in the worse-seeing eye.
  • Must be at least the following age at the time of enrollment: 25 (USA, Switzerland) or 18 (France, U.K., and Mexico) years old
  • Must reside within 2 hours (USA, UK and Mexico) or 3 hours (France and Switzerland) distance (by ground transportation) of the investigational site.
  • Must be willing and able to comply with the protocol testing and follow-up requirements.

You may not qualify if:

  • Optic Nerve disease
  • History of glaucoma
  • Optic neuropathy or other confirmed damage to optic nerve or visual cortex damage
  • Diseases or conditions that effect retinal function including but not limited to:
  • Central retinal artery/vein occlusion (CRAO or CRVO)
  • End-stage diabetic retinopathy
  • Retinal detachment or history of retinal detachment
  • Trauma
  • Infectious or inflammatory retinal diseases
  • Diseases or conditions that prevent adequate visualization of the retina including, but not limited to corneal degeneration that cannot be resolved before implant.
  • Diseases or conditions of the anterior segment that prevent the ability to adequately perform the physical examination including but not limited to trauma or lid malpositions.
  • Diseases of the ocular surface including but not limited to keratitis sicca.
  • An ocular condition that predisposes the subject to eye rubbing.
  • Any disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols, including:
  • Cognitive decline including diagnosed forms of dementia and/or progressive neurological disease
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Doheny Eye Institute

Los Angeles, California, 90033, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Johns Hopkins, Wilmer Eye Institute

Baltimore, Maryland, 21205, United States

Location

Columbia University, Department of Ophthalmology, Edward S. Harkness Eye Institute

New York, New York, 10032, United States

Location

University of Pennsylvania, Scheie Eye Institute

Philadelphia, Pennsylvania, 19104, United States

Location

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Retina Foundation of the Southwest

Dallas, Texas, 75231, United States

Location

Centre d'Investigation Clinique, Service d'Ophtalmologie, Quinze-Vingts National Eye Hospital, 28 rue de Charenton, 75557 Cedex 12

Paris, France

Location

Puerta de Hierro, Centro Medico, Centro de Retina

Zapopan, Jalisco, 51116, Mexico

Location

Clinique d'Ophthalmologie Hopitaux, Universitaires de Geneve 22 rue Alcide Jentzer 1205

Geneva, Switzerland

Location

Moorfields Eye Hospital, Vitreoretinal Research Unit

London, EC1V 2PD, United Kingdom

Location

Manchester Royal Eye Hospital

Manchester, United Kingdom

Location

Related Publications (13)

  • Weiland JD, Faraji B, Greenberg RJ, Humayun MS, Shellock FG. Assessment of MRI issues for the Argus II retinal prosthesis. Magn Reson Imaging. 2012 Apr;30(3):382-9. doi: 10.1016/j.mri.2011.12.005. Epub 2012 Jan 20.

    PMID: 22260934BACKGROUND

  • Humayun MS, Dorn JD, da Cruz L, Dagnelie G, Sahel JA, Stanga PE, Cideciyan AV, Duncan JL, Eliott D, Filley E, Ho AC, Santos A, Safran AB, Arditi A, Del Priore LV, Greenberg RJ; Argus II Study Group. Interim results from the international trial of Second Sight's visual prosthesis. Ophthalmology. 2012 Apr;119(4):779-88. doi: 10.1016/j.ophtha.2011.09.028. Epub 2012 Jan 11.

    PMID: 22244176RESULT

  • Barry MP, Dagnelie G; Argus II Study Group. Use of the Argus II retinal prosthesis to improve visual guidance of fine hand movements. Invest Ophthalmol Vis Sci. 2012 Aug 1;53(9):5095-101. doi: 10.1167/iovs.12-9536.

    PMID: 22661464RESULT

  • Ahuja AK, Dorn JD, Caspi A, McMahon MJ, Dagnelie G, Dacruz L, Stanga P, Humayun MS, Greenberg RJ; Argus II Study Group. Blind subjects implanted with the Argus II retinal prosthesis are able to improve performance in a spatial-motor task. Br J Ophthalmol. 2011 Apr;95(4):539-43. doi: 10.1136/bjo.2010.179622. Epub 2010 Sep 29.

    PMID: 20881025RESULT

  • Arevalo JF, Al Rashaed S, Alhamad TA, Al Kahtani E, Al-Dhibi HA; KKESH Collaborative Retina Study Group. Argus II retinal prosthesis for retinitis pigmentosa in the Middle East: The 2015 Pan-American Association of Ophthalmology Gradle Lecture. Int J Retina Vitreous. 2021 Oct 27;7(1):65. doi: 10.1186/s40942-021-00324-6.

    PMID: 34706764DERIVED

  • Sabbah N, Authie CN, Sanda N, Mohand-Said S, Sahel JA, Safran AB. Importance of eye position on spatial localization in blind subjects wearing an Argus II retinal prosthesis. Invest Ophthalmol Vis Sci. 2014 Nov 20;55(12):8259-66. doi: 10.1167/iovs.14-15392.

    PMID: 25414187DERIVED

  • Ahuja AK, Yeoh J, Dorn JD, Caspi A, Wuyyuru V, McMahon MJ, Humayun MS, Greenberg RJ, Dacruz L. Factors Affecting Perceptual Threshold in Argus II Retinal Prosthesis Subjects. Transl Vis Sci Technol. 2013 Apr;2(4):1. doi: 10.1167/tvst.2.4.1. Epub 2013 Apr 12.

    PMID: 24049718DERIVED

  • de Juan E Jr, Spencer R, Barale PO, da Cruz L, Neysmith J. Extraction of retinal tacks from subjects implanted with an epiretinal visual prosthesis. Graefes Arch Clin Exp Ophthalmol. 2013 Oct;251(10):2471-6. doi: 10.1007/s00417-013-2452-y. Epub 2013 Sep 8.

    PMID: 24013578DERIVED

  • Stronks HC, Barry MP, Dagnelie G. Electrically elicited visual evoked potentials in Argus II retinal implant wearers. Invest Ophthalmol Vis Sci. 2013 Jun 6;54(6):3891-901. doi: 10.1167/iovs.13-11594.

    PMID: 23611993DERIVED

  • Dorn JD, Ahuja AK, Caspi A, da Cruz L, Dagnelie G, Sahel JA, Greenberg RJ, McMahon MJ; gus II Study Group. The Detection of Motion by Blind Subjects With the Epiretinal 60-Electrode (Argus II) Retinal Prosthesis. JAMA Ophthalmol. 2013 Feb;131(2):183-9. doi: 10.1001/2013.jamaophthalmol.221.

    PMID: 23544203DERIVED

  • Ahuja AK, Behrend MR. The Argus II retinal prosthesis: factors affecting patient selection for implantation. Prog Retin Eye Res. 2013 Sep;36:1-23. doi: 10.1016/j.preteyeres.2013.01.002. Epub 2013 Mar 14.

    PMID: 23500412DERIVED

  • Olson JL, Velez-Montoya R, Mandava N, Stoldt CR. Intravitreal silicon-based quantum dots as neuroprotective factors in a model of retinal photoreceptor degeneration. Invest Ophthalmol Vis Sci. 2012 Aug 17;53(9):5713-21. doi: 10.1167/iovs.12-9745.

    PMID: 22761263DERIVED

  • Perez Fornos A, Sommerhalder J, da Cruz L, Sahel JA, Mohand-Said S, Hafezi F, Pelizzone M. Temporal properties of visual perception on electrical stimulation of the retina. Invest Ophthalmol Vis Sci. 2012 May 4;53(6):2720-31. doi: 10.1167/iovs.11-9344.

    PMID: 22447863DERIVED

MeSH Terms

Conditions

Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Jessy Dorn, PhD, Director of Clinical and Scientific Affiars
Organization
Second Sight Medical Products, Inc.
jdorn@secondsight.com
8188335089

Study Officials

  • Anne-Marie Ripley

    Second Sight Medical Products

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

December 1, 2006

First Posted

December 5, 2006

Study Start

September 1, 2006

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

January 20, 2022

Results First Posted

December 30, 2021

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)FR(1)ME(1)US(7)CH(1)