Retinitis PigmentosaNCT03629899
RETINA IMPLANT Alpha AMS in Blind Patients With Retinitis Pigmentosa
A study testing RETINA IMPLANT Alpha AMS in people with Retinitis Pigmentosa, run by Wills Eye at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Retinitis Pigmentosa
- What is being tested?
- RETINA IMPLANT Alpha AMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2019to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Blind RP patients with LP or NLP identified in both eyes using a photoflash test.
- (NLP inclusion is defined as participants who at screening give less than 9 correct answers out of 20 trials to the photoflash test; LP inclusion is defined as participants who at screening give 9 or more correct answers out of 20 trials to the 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 28Show fewer
- 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.
- Patients with plastic intra-ocular lenses, or other materials, that would interact with silicone oil.
- Women who are pregnant or nursing, or women of childbearing potential 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.
- Neurological and / or psychiatric diseases (e.g., Parkinson, epilepsy, MS, depression or severe anxiety).
- Lack of cognitive and / or emotional ability (e.g., depression or severe anxiety) limiting participation as assessed by psychiatric evaluation.
- Participation in another interventional clinical trial within the past 30 days.
- The need for regular administration of anticoagulants, platelet aggregation inhibitors or analgesics containing acetylsalicylic acid.
- Disease or conditions that likely require regular use of MRI or other similar imaging technology that emits electromagnetic radiation.
- Patients unwilling to avoid participating in vigorous sports or activities with a high risk of a head injury.
- Patients unwilling to avoid security-scanning devices that would result in a full body, manual search.
- Ability to perceive form or motion under optimal conditions (largest size, brightest lighting, highest contrast, etc.) of form and motion testing as tested by BaLM, BaGA, and Landolt C.
- Patients with hearing deficits and cochlear implants or patients who may be implanted with cochlear implants in the near future.
- Patients undergoing or requiring medical treatments generating induced currents in the area of the implant such as electrosurgery, diathermy, neurostimulation, electroconvulsive therapy, ionizing radiation therapy, therapeutic ultrasound.
- Subjects with no active immunization status against organisms causing meningitis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: Early Feasibility Study of the RETINA IMPLANT Alpha AMS in Blind Patients With Retinitis Pigmentosa
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.
Read the detailed description
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.
- Conditions
- Retinitis Pigmentosa
- Being tested
- RETINA IMPLANT Alpha AMS
- Keywords
- Retinitis Pigmentosa, Inherited Retinal Degeneration, Retina Implant, Retinal Prosthesis, Artificial Vision
- Medical subject headings
- Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RETINA IMPLANT Alpha AMSDevice
Implantation of the subretinal RETINA IMPLANT Alpha AMS
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: RETINA IMPLANT Alpha AMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, 5 years
Secondary outcomes (4)
Change in visual function
Visual function will be assessed with the implant "ON" vs. "OFF" using Basic Light Localization and Motion Test (BaLM/BaGA).
Measured: Baseline, 1, 2, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 52, 60 months post surgery
Change in Visual Acuity
Change in visual acuity will be measured with the implant "ON" vs "OFF" using Landolt C-optotypes.
Measured: Baseline, 1, 2, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 52, 60 months post surgery
Changes in response to photoflash test
Changes in response to photoflash test
Measured: Baseline, 1, 2, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 52, 60 months post surgery
Change in Activities of Daily Living
Changes in daily life situations will be assessed in a real world environment with the implant "ON" vs "OFF"
Measured: Baseline, 1, 2, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 52, 60 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study startMar 2019 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Why it stopped: unavailability of the investigational device
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Retinitis PigmentosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Collaborators
- Retina Implant AG
- Responsible party
- Sponsor
- Investigators
- Jay Federman, MD, Study director, Wills Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629899
- Sponsor's protocol ID
- 17-645
- Status last verified
- May 2019
- First submitted
- 23 Jul 2018
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 28878616Edwards 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.
PubMed 29110946
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study of the RETINA IMPLANT Alpha AMS in Blind Patients With Retinitis Pigmentosa
- ClinicalTrials.gov ID
- NCT03629899
- Acronym / sponsor ID
- 17-645
- Conditions
- Retinitis Pigmentosa
- Keywords
- Retinitis Pigmentosa, Inherited Retinal Degeneration, Retina Implant, Retinal Prosthesis, Artificial Vision
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unavailability of the investigational device
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Collaborators
- Retina Implant AG
- Study start
- Mar 2019 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RETINA IMPLANT Alpha AMS | Experimental | Device: RETINA IMPLANT Alpha AMSAfter 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Blind RP patients with LP or NLP identified in both eyes using a photoflash test.
- (NLP inclusion is defined as participants who at screening give less than 9 correct answers out of 20 trials to the photoflash test; LP inclusion is defined as participants who at screening give 9 or more correct answers out of 20 trials to the 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.
Key exclusion criteria (28 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RETINA IMPLANT Alpha AMSImplantation of the subretinal RETINA IMPLANT Alpha AMS | Device | RETINA IMPLANT Alpha AMS |
Primary outcome
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.
4 secondary outcomes
Change in visual function
Time frame: Baseline, 1, 2, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 52, 60 months post surgery
Change in Visual Acuity
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
Time frame: Baseline, 1, 2, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 52, 60 months post surgery
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Background: PubMed 28878616Stingl 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.
- Background: PubMed 29110946Edwards 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.
- Individual participant dataSharing planned: Undecided
Related trials for Retinitis Pigmentosa
RecruitingObservational study
Rod and Cone Mediated Function in Retinal Disease
Retinal Degeneration, Retinitis Pigmentosa
RecruitingObservational study
Cell Collection to Study Eye Diseases
Retinal Disease, AMD
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
RecruitingObservational study
Universal Rare Gene Study: A Registry and Natural History Study of Retinal Dystrophies Associated With Rare Disease-Causing Genetic Variants
Inherited Retinal Degeneration, Retinitis Pigmentosa
Active, not recruitingObservational study
Rate of Progression in EYS Related Retinal Degeneration
Retinitis Pigmentosa, Eye Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay Federman, MD study director
Wills Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RETINA IMPLANT Alpha AMS in people with Retinitis Pigmentosa, run by Wills Eye at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Incidence of procedure or implant related adverse events (time frame: Through study completion, 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03629899, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2019.