Retinitis Pigmentosa Clinical Trial
— OX-RIOfficial title:
Safety and Efficacy of the Alpha AMS Subretinal Implant for Partial Restoration of Vision in Visually Impaired Participants With Degenerative Retinal Disease
Verified date | November 2017 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 6 |
Est. completion date | October 2017 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Oxford University Hospitals NHS Foundation Trust | Oxford | Oxfordshire |
Lead Sponsor | Collaborator |
---|---|
University of Oxford |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Efficacy of the Alpha AMS retinal implant system used for partial restoration of visual acuity. | Visual acuity or light-perception and/or object-recognition assessed with implant ON versus OFF via • Freiburg visual Acuity and Contrast Test (FrACT) |
12 months | |
Secondary | Efficacy of the Alpha AMS retinal implant system used for partial restoration of basic light detection.. | Visual acuity or light-perception and/or object-recognition assessed with implant ON versus OFF via: • Basic Light and Motion test (BaLM) |
12 months | |
Secondary | Efficacy of the Alpha AMS retinal implant system used for partial restoration of grating acuity. | Visual acuity or light-perception and/or object-recognition assessed with implant ON versus OFF via: • Basic Grating Acuity test (BaGA). |
12 months | |
Secondary | Safety of the Alpha AMS retinal implant. | The number of participant with Adverse Events and/or Serious Adverse Events, as defined by the Study Protocol, will be reported. | 12 months |
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