RETINA IMPLANT Alpha AMS in Blind Patients With Retinitis Pigmentosa

NCT03629899 | Withdrawn DMC FDA Device

• 1 other identifier: 17-645
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to transfer the surgical implantation technique and evaluate the safety and effectiveness of the RETINA IMPLANT Alpha AMS to restore limited visual function and functional vision in blind Retinitis Pigmentosa (RP) patients who are at the Light Perception (LP) or No Light Perception vision level (NLP). The safety of the implantation procedure and the long-term presence of the RETINA IMPLANT Alpha AMS will be assessed with clinical exams and objective clinical tests for the absence of any new permanent damage to the structure and function of the implanted eye with no permanent injury to the health and/or well being of the implanted patient as a result of the surgical procedure or presence of the implant. The effectiveness of the RETINA IMPLANT Alpha AMS will be evaluated by measuring limited visual function and functional vision in implanted subjects with the device "ON" and "OFF" in a randomized order. The ability to restore limited vision in blind RP patients with LP vision or NLP will reduce their disability and morbidity and provide a viable option to combat their disease and improve their lives.

Conditions

Retinitis Pigmentosa

Keywords

Retinitis Pigmentosa; Inherited Retinal Degeneration; Retina Implant; Retinal Prosthesis; Artificial Vision

Outcome Measures

Primary Outcomes (1)

• Safety - Incidence of procedure or implant related adverse events

  The safety endpoint is the absence of any new permanent damage to the function and structure of the implanted eye, consisting of new neovascularization, epiretinal membrane formation, and subretinal fibrotic tissue formation, and no permanent damage to the health and/or well-being of the subject following implantation as a result of the surgical procedure or presence of the implant.

  Through study completion, 5 years

Secondary Outcomes (4)

• Change in visual function

  Baseline, 1, 2, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 52, 60 months post surgery

• Change in Visual Acuity

  Baseline, 1, 2, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 52, 60 months post surgery

• Changes in response to photoflash test

  Baseline, 1, 2, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 52, 60 months post surgery

• Change in Activities of Daily Living

  Baseline, 1, 2, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 52, 60 months post surgery

Study Arms (1)

RETINA IMPLANT Alpha AMS

EXPERIMENTAL

After implantation surgery, every single sub-test will be performed with randomized implant activation ("ON" or "OFF"). During every trial of each sub-test there will be a study coordinator and a technician. The study coordinator will have a set randomization examination schedule while the technician will record patient response without knowledge of the randomization examination schedule. The patient, technician and investigator will all be masked to the testing conditions.

Device: RETINA IMPLANT Alpha AMS

Interventions

RETINA IMPLANT Alpha AMS DEVICE

Implantation of the subretinal RETINA IMPLANT Alpha AMS

RETINA IMPLANT Alpha AMS

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Blind RP patients with LP or NLP identified in both eyes using a photoflash test.
• Pseudophakia for at least 3 months prior to entrance into study.
• Central visual function of 12 years / lifetime or greater with a history of reading vision in the eye to be implanted.
• Fluorescein angiography showing retinal vascular perfusion in all four quadrants of macula.
• Fifty (50) years of age or older at time of enrollment.
• Evidence of inner retinal function (ganglion cells and optic nerve function) by EEP test identified by the ability to elicit phosphene thresholds.
• ERG showing rod and cone non-function.
• Willing and able to give written informed consent and participate in ongoing follow-up.

You may not qualify if:

• Ophthalmic conditions other than RP with relevant effect upon visual function (e.g., glaucoma, optic neuropathies, trauma, diabetic retinopathy, retinal detachment, macular degeneration, cystoid macular edema, MS) with the addition of tobacco, alcohol abuse and retinotoxic drugs e.g. plaquenil and thorazine.
• Any other ocular disease that affects retina and / or optic nerve function.
• Opacification of ocular structures that prevent clear image transmission.
• Nystagmus.
• Cystoid macular edema within target region for implantation shown via Optical Coherence Tomography (OCT).
• Retina detected as too thin as shown via OCT (\<100 μm) to expect required functionality of inner retina and /or OCT shows no layering of the inner retina in the central region.
• Scar tissue (e.g., epiretinal, intraretinal, subretinal, macular pucker) within target region for implantation.
• Heavily clumped pigmentation at posterior pole (would interfere with image transmission to vision chip).
• Anterior segment pathology that interferes with clear visualization of the retina (e.g., presence of cloudy or scarred cornea and / or papillary membrane) that cannot be resolved prior to entrance into study.
• 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, severe metabolic diseases).
• Any condition and / or allergic contraindication to pre-operative, intra-operative, and post-operative medication.
• Health problems where general anesthesia is contraindicated.
• Disease or conditions that would probably limit life expectancy to less than 1 year from screening.
• Orbital deformity that would interfere with surgical implantation that could not be resolved prior to entrance into study.

Sponsors & Collaborators

• Wills Eye: lead
• Retina Implant AG: collaborator

Study Sites (1)

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (2)

• 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 BACKGROUND

• Edwards TL, Cottriall CL, Xue K, Simunovic MP, Ramsden JD, Zrenner E, MacLaren RE. Assessment of the Electronic Retinal Implant Alpha AMS in Restoring Vision to Blind Patients with End-Stage Retinitis Pigmentosa. Ophthalmology. 2018 Mar;125(3):432-443. doi: 10.1016/j.ophtha.2017.09.019. Epub 2017 Oct 27.

  PMID: 29110946 BACKGROUND

MeSH Terms

Conditions

Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

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

Study Officials

• Jay Federman, MD

  Wills Eye Hospital

  STUDY DIRECTOR

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: July 23, 2018
• First Posted: August 14, 2018
• Study Start: March 1, 2019
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: May 10, 2019

Record last verified: 2019-05

Locations

US (1)