RETINA IMPLANT Alpha AMS in Blind Patients With Retinitis Pigmentosa
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|ClinicalTrials.gov Identifier: NCT03629899|
Recruitment Status : Withdrawn (unavailability of the investigational device)
First Posted : August 14, 2018
Last Update Posted : May 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Retinitis Pigmentosa||Device: RETINA IMPLANT Alpha AMS||Not Applicable|
Retinitis Pigmentosa (RP) is a rare genetic disorder albeit the most common cause of inherited blindness. With progressive loss of function and cells in the outer retina, individuals with RP can progress to complete blindness of Light Perception or No Light Perception. There is no known cure or treatment for RP individuals at the Light Perception or No Light Perception phase of this progressive degenerative disease. The RETINA IMPLANT Alpha AMS is an investigational device designed to restore limited visual function and functional vision in this subset of patients suffering with RP whose visual acuity has deteriorated to the level of Light Perception or No Light Perception.
The RETINA IMPLANT Alpha AMS has been designed to replace the non-functioning and absent photoreceptor cells with a functional device to stimulate the remaining components of the retina to restore limited visual function and functional vision in patients with RP. The RETINA IMPLANT Alpha AMS device is surgically implanted subretinally to replace the non-functioning pathologic photoreceptor/RPE layer (or absent photoreceptor cells and defective pigment epithelium). The focusing lens system of the eye directs the visual image onto the device. When turned "ON" the device then stimulates the remaining visual cells of the inner layers of the retina and this visual information is subsequently transmitted by the remaining retinal network via the optic nerve to the visual cortex in the Central Nervous System (CNS).
This investigation is an Early Feasibility Study and will seek to implant five (5) to eight (8) patients. One surgical team, highly experienced in similar vitreoretinal procedures will be trained and will implant the enrolled patients. Follow-up visits for each patient will include an evaluation of safety and effectiveness at various time periods with follow-up continuing through five (5) years.
The use of masking in this clinical trial will be employed at the level of implanted subjects undergoing effectiveness evaluations during the follow-up visits as further described. Implant "ON" and "OFF" modality will be randomized and unknown to each subject undergoing functional vision tests during the follow-up visit. The "ON" and "OFF" will be encoded as either mode-1 or mode-2; for each test run, mode-1 and mode-2 will be differently encoded. The subject's visual performance will be evaluated and recorded for both "ON" and "OFF" implant conditions.
Each potential subject will undergo screening and evaluation to document that the eligibility criteria have been met and for proper surgical planning for implantation of the RETINA IMPLANT Alpha AMS. Qualifying subjects will undergo surgical implantation of the RETINA IMPLANT Alpha AMS in one eye and will be followed immediately in the post-operative period. Follow-up will continue for five (5) years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Feasibility Study of the RETINA IMPLANT Alpha AMS in Blind Patients With Retinitis Pigmentosa|
|Estimated Study Start Date :||March 2019|
|Estimated Primary Completion Date :||July 2025|
|Estimated Study Completion Date :||July 2025|
Experimental: RETINA IMPLANT Alpha AMS
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
Implantation of the subretinal RETINA IMPLANT Alpha AMS
- Safety - Incidence of procedure or implant related adverse events [ Time Frame: Through study completion, 5 years ]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.
- Change in visual function [ Time Frame: Baseline, 1, 2, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 52, 60 months post surgery ]Visual function will be assessed with the implant "ON" vs. "OFF" using Basic Light Localization and Motion Test (BaLM/BaGA).
- Change in Visual Acuity [ Time Frame: Baseline, 1, 2, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 52, 60 months post surgery ]Change in visual acuity will be measured with the implant "ON" vs "OFF" using Landolt C-optotypes.
- Changes in response to photoflash test [ Time Frame: Baseline, 1, 2, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 52, 60 months post surgery ]Changes in response to photoflash test
- Change in Activities of Daily Living [ Time Frame: Baseline, 1, 2, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 52, 60 months post surgery ]Changes in daily life situations will be assessed in a real world environment with the implant "ON" vs "OFF"
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03629899
|United States, Pennsylvania|
|Wills Eye Hospital|
|Philadelphia, Pennsylvania, United States, 19107|
|Study Director:||Jay Federman, MD||Wills Eye Hospital|