NCT02588430

Brief Summary

This study is a post-market clinical follow-up (PMCF) study to monitor the safety, lifetime and efficacy of patients using the CE-certified RETINA IMPLANT Alpha AMS.

Trial Health

50
Monitor

Trial Health Score

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

Timeline
48mo left

Started Mar 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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 Progress65%
Mar 2019Jun 2030

First Submitted

Initial submission to the registry

September 30, 2014

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
3.3 years until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2030

Last Updated

April 19, 2019

Status Verified

April 1, 2019

Enrollment Period

10.8 years

First QC Date

September 30, 2014

Last Update Submit

April 17, 2019

Conditions

Retinitis Pigmentosa

Outcome Measures

Primary Outcomes (3)

  • Time to device failure

    Recording of device failures

    6 Years

  • Number, nature and severity of challenges or complications during surgical procedures

    Recording of adverse events

    6 Years

  • Number, nature and severity of device-related adverse events and incidents until device failure or explantation

    Recording of adverse events

    6 Years

Secondary Outcomes (5)

  • 1. Functional Vision Test

    6 Years

  • 2. Functional Vision Test

    6 Years

  • 3. Functional Vision Test

    6 Years

  • 4. Functional Vision Tests

    6 Years

  • Visual related quality of life (Patient reported outcome)

    6 Years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who received a Retina Implant Alpha at the study site. Patients who are fulfilling specific criteria to receive a RETINA IMPLANT Alpha AMS.

You may qualify if:

  • Patients who received a RETINA IMPLANT Alpha AMS.
  • Patients willing and able to give written informed consent.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Katharinenhospital Stuttgart

Stuttgart, 70174, Germany

Location

Related Publications (3)

  • Stingl K, Bartz-Schmidt KU, Besch D, Braun A, Bruckmann A, Gekeler F, Greppmaier U, Hipp S, Hortdorfer G, Kernstock C, Koitschev A, Kusnyerik A, Sachs H, Schatz A, Stingl KT, Peters T, Wilhelm B, Zrenner E. Artificial vision with wirelessly powered subretinal electronic implant alpha-IMS. Proc Biol Sci. 2013 Feb 20;280(1757):20130077. doi: 10.1098/rspb.2013.0077. Print 2013 Apr 22.

    PMID: 23427175BACKGROUND

  • Koitschev A, Stingl K, Bartz-Schmidt KU, Braun A, Gekeler F, Greppmaier U, Sachs H, Peters T, Wilhelm B, Zrenner E, Besch D. Extraocular Surgical Approach for Placement of Subretinal Implants in Blind Patients: Lessons from Cochlear-Implants. J Ophthalmol. 2015;2015:842518. doi: 10.1155/2015/842518. Epub 2015 Dec 10.

    PMID: 26783453BACKGROUND

  • 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: 25812924BACKGROUND

MeSH Terms

Conditions

Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

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

Study Officials

  • Florian Gekeler, Prof Dr med

    Katharinenhospital Stuttgart

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
6 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2014

First Posted

October 27, 2015

Study Start

March 1, 2019

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

June 1, 2030

Last Updated

April 19, 2019

Record last verified: 2019-04

Locations

DE(1)