Safety and Efficacy of the Alpha AMS Subretinal Implant

NCT02720640 | Completed DMC

• 1 other identifier: E/2015/0119
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this single-centre study is to assess the safety and efficacy of the Retina Implant Alpha AMS (Retina Implant AG, Reutlingen, Germany) in participants with severe visual impairment secondary to outer retinal degeneration caused by retinitis pigmentosa (RP). The study is sponsored by the University of Oxford and funded by the National Institute for Health Research (UK).

Conditions

Retinitis Pigmentosa

Outcome Measures

Primary Outcomes (1)

• Efficacy of the Alpha AMS retinal implant system used for activities of daily living tasks.

  Activities of daily living are assessed with implant ON versus OFF via: • Activities of daily living tasks

  12 months

Secondary Outcomes (4)

• Efficacy of the Alpha AMS retinal implant system used for partial restoration of visual acuity.

  12 months

• Efficacy of the Alpha AMS retinal implant system used for partial restoration of basic light detection..

  12 months

• Efficacy of the Alpha AMS retinal implant system used for partial restoration of grating acuity.

  12 months

• Safety of the Alpha AMS retinal implant.

  12 months

Study Arms (1)

Implant 'on' vs implant 'off'

EXPERIMENTAL

Intra-individual comparison of implant 'on' vs implant 'off'

Device: Implant 'on' vs implant 'off'

Interventions

Implant 'on' vs implant 'off' DEVICE

Single group assignment

Also known as: Alpha AMS, Retinal Implant Alpha AMS, Retinal implant, Bionic eye, Retinal prosthesis, Sub retinal chip

Implant 'on' vs implant 'off'

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the trial.
• Male or Female, aged 18 to 70 years old.
• Hereditary retinal degeneration of the outer retinal layers i.e. photoreceptor rods \& cones.
• Angiography shows retinal vessels adequately perfused, despite pathological RP condition.
• Severe visual impairment (at least monocular) i.e. visual functions insufficient for localization of objects, self-sustained navigation and orientation e.g. impaired light localization or worse.
• Ability to read normal print in earlier life, optically corrected (without magnifying glass).
• Able to participate in the study during the full time period of one year.
• Pseudophakic in the eye to receive the implant.
• Stable dose of current regular medication for at least four weeks prior to trial entry.
• Female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial.
• Participant has clinically acceptable laboratory and ECG results as confirmed at - Screening Visit and upon review by consultant anaesthetist.
• In the Investigator's opinion, is able and willing to comply with all trial requirements.
• Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.

You may not qualify if:

• Period of appropriate visual functions \< 12 years / lifetime.
• Optical coherence tomography (OCT) shows significant retina oedema \&/or scar tissue within target region for implant.
• Retina detected as too thin to expect required functionality of inner retina as shown via 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 for eye to be implanted.
• Systemic diseases that might imply considerable risks with regard to the surgical interventions and anesthesia (e.g. cardiovascular/ pulmonary diseases, significant metabolic diseases e.g. diabetes).
• Neurological and/or psychiatric diseases (e.g. Parkinson, epilepsy, depression).
• Hyperthyroidism or hypersensitivity to iodine.
• Hypersensitivity to fluorescent dye (fluorescence angiography).
• Women who are pregnant or nursing, or women of childbearing age 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 12 weeks.
• Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Related Publications (2)

• Cehajic Kapetanovic J, Troelenberg N, Edwards TL, Xue K, Ramsden JD, Stett A, Zrenner E, MacLaren RE. Highest reported visual acuity after electronic retinal implantation. Acta Ophthalmol. 2020 Nov;98(7):736-740. doi: 10.1111/aos.14443. Epub 2020 Apr 28.

  PMID: 32343050 DERIVED

• Stingl K, Schippert R, Bartz-Schmidt KU, Besch D, Cottriall CL, Edwards TL, Gekeler F, Greppmaier U, Kiel K, Koitschev A, Kuhlewein L, MacLaren RE, Ramsden JD, Roider J, Rothermel A, Sachs H, Schroder GS, Tode J, Troelenberg N, Zrenner E. Interim Results of a Multicenter Trial with the New Electronic Subretinal Implant Alpha AMS in 15 Patients Blind from Inherited Retinal Degenerations. Front Neurosci. 2017 Aug 23;11:445. doi: 10.3389/fnins.2017.00445. eCollection 2017.

  PMID: 28878616 DERIVED

MeSH Terms

Conditions

Retinitis Pigmentosa

Interventions

Visual Prosthesis

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Robert E MacLaren, DPhil FRCS

  1. Nuffield Laboratory of Ophthalmology, Department of Clinical Neurosciences, University of Oxford; 2. Oxford Eye Hospital, Oxford University Hospitals NHS Foundation Trust; 3. Moorfields Eye Hospital NHS Foundation Trust, London

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 4, 2015
• First Posted: March 28, 2016
• Study Start: May 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: November 17, 2017

Record last verified: 2017-11

Locations

GB (1)