A. AMD Patients, Where at Least One Eye is With Active CNV, Presenting Retinal Fluid at the Enrolment Visit, Undergoing Active Anti-VEGF TreatmentNCT04241198
Home Retinal Imaging Using NOTAL-OCT V3.0
An observational study of A. AMD Patients, Where at Least One Eye is With Active CNV, Presenting Retinal Fluid at the Enrolment Visit, Undergoing Active Anti-VEGF Treatment, run by Notal Vision Ltd. at 1 site in Israel.
Trial summary
The study will include up to 30 AMD patients, recruited by two medical centers, Tel-Aviv medical center and Assuta Hashalom medical center. At the screening visit, the patients will be imaged in their tested, eligible eye(s), using a commercial Zeiss Cirrus or Heidelberg Spectralis OCT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- A. AMD Patients, Where at Least One Eye is With Active CNV, Presenting Retinal Fluid at the Enrolment Visit, Undergoing Active Anti-VEGF Treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- 9 Jun 2020to 28 Mar 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: AMD patients, where at least one eye is with active CNV, presenting retinal fluid at the enrolment visit, undergoing active anti-VEGF treatment
Who may be able to join
- Ability and willingness to give informed consent (IC)
- 18 years of age or older at the time of IC
- Tested eye(s) diagnosed with AMD
- Visual acuity of 20/400 Snellen (6/120) or better in the study eye
- At least one eye is with active CNV, presenting retinal fluid at the enrolment visit, undergoing active anti-VEGF treatment
- Ability to undergo OCT testing
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
About this study
The study will include up to 30 AMD patients, recruited by two medical centers, Tel-Aviv medical center and Assuta Hashalom medical center. At the screening visit, the patients will be imaged in their tested, eligible eye(s), using a commercial Zeiss Cirrus or Heidelberg Spectralis OCT.
Read the detailed description
Screening visit:
For patients eligible to participate in the study, the following procedure will be done in the "screening visit" at the clinic:
- Patient will sign the IC (Informed Consent) form
- The following demographic and clinical data will be collected and registered in the CRF:
- Patient's DOB and gender.
- Patient's diagnosis in study eye(s), based on patient's medical record, including media opacity (e.g. cataract or corneal opacity, if exists).
- Bio-microscopy testing.
- Refraction correction by an optometrist.
- Habitual Snellen visual acuity
- Commercial OCT scanning using Zeiss Cirrus or Heidelberg Spectralis.
OCT scanning pattern:
- Macular cube of at least 6X6mm (20 degrees)
- At least 40 B-scans per cube
Setup and tutorial home visit:
The device will be delivered to the patient's home with a setup guide attached to the package. The patient will read the setup guide instructions, unpack the device, place it on a table and connect it to a power supply. Upon first usage a tutorial clip, explaining how to operate the device and self-image the eyes, will be automatically displayed on the device's external screen. Following the tutorial patients will be instructed to scan their study eye(s). A remote support service, provided by the sponsor, will be available as needed. Its phone number will be given to the patient and will be attached to the device's base.
Daily home testing:
For each eligible eye, the following procedure will be done in the "Daily testing" at the patients' homes:
- The patients will be requested to self-scan their study eye(s) daily, using the NOTAL-OCT V3.0..
- The patient will be able call the sponsor's remote support service, during working hours, for assistance in case of questions or problems regarding the operation the NOTAL-OCT V3.0 device.
Exit visit:
For each eligible eye, the following procedure will be done in the "Exit visit" at the clinic:
- Bio-microscopy testing.
- Refraction correction by an optometrist.
- Habitual Snellen visual acuity
- Commercial OCT scanning using Zeiss Cirrus or Heidelberg Spectralis.
OCT scanning pattern:
- Macular cube of at least 6X6mm (20 degrees)
- At least 40 B-scans per cube NOTAL-OCT V3.0 Scanning. 6.Patient's experience questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the dynamics of retinal fluid
To describe the dynamics of retinal fluid in eyes undergoing anti-VEGF therapy as manifested in self-operated OCT in daily home testing
Measured: 30 days
Secondary outcomes (2)
To evaluate patient experience when self-operating the Notal-OCT V3.0.
by a patient experience questionnaire.
Measured: 30 days
E. To evaluate the level of agreement between OCT images captured by Notal-OCT V3.0 and a commercial OCT
- To evaluate the level of agreement between OCT images captured by Notal-OCT V3.0 and a commercial OCT, for the presence of fluid, in the central 10 degrees of the macula, at screening and exit visits.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start9 Jun 2020
- Primary completion30 Jul 2022
- Study completion28 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for A. AMD Patients, Where at Least One Eye is With Active CNV, Presenting Retinal Fluid at the Enrolment Visit, Undergoing Active Anti-VEGF TreatmentStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Notal Vision Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- michaela Glodstein, Dr, Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241198
- Sponsor's protocol ID
- Home Imaging using NOTAL-OCT
- Status last verified
- Apr 2023
- First submitted
- 22 Jan 2020
- Last updated
- 15 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Retinal Imaging Using NOTAL-OCT V3.0
- ClinicalTrials.gov ID
- NCT04241198
- Acronym / sponsor ID
- Home Imaging using NOTAL-OCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Notal Vision Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jun 2020 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 27 Jan 2020 (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 study will include up to 30 AMD patients, recruited by two medical centers, Tel-Aviv medical center and Assuta Hashalom medical center. At the screening visit, the patients will be imaged in their tested, eligible eye(s), using a commercial Zeiss Cirrus or Heidelberg Spectralis OCT.
Detailed description
Screening visit:
For patients eligible to participate in the study, the following procedure will be done in the "screening visit" at the clinic:
- Patient will sign the IC (Informed Consent) form
- The following demographic and clinical data will be collected and registered in the CRF:
- Patient's DOB and gender.
- Patient's diagnosis in study eye(s), based on patient's medical record, including media opacity (e.g. cataract or corneal opacity, if exists).
- Bio-microscopy testing.
- Refraction correction by an optometrist.
- Habitual Snellen visual acuity
- Commercial OCT scanning using Zeiss Cirrus or Heidelberg Spectralis.
OCT scanning pattern:
- Macular cube of at least 6X6mm (20 degrees)
- At least 40 B-scans per cube
Setup and tutorial home visit:
The device will be delivered to the patient's home with a setup guide attached to the package. The patient will read the setup guide instructions, unpack the device, place it on a table and connect it to a power supply. Upon first usage a tutorial clip, explaining how to operate the device and self-image the eyes, will be automatically displayed on the device's external screen. Following the tutorial patients will be instructed to scan their study eye(s). A remote support service, provided by the sponsor, will be available as needed. Its phone number will be given to the patient and will be attached to the device's base.
Daily home testing:
For each eligible eye, the following procedure will be done in the "Daily testing" at the patients' homes:
- The patients will be requested to self-scan their study eye(s) daily, using the NOTAL-OCT V3.0..
- The patient will be able call the sponsor's remote support service, during working hours, for assistance in case of questions or problems regarding the operation the NOTAL-OCT V3.0 device.
Exit visit:
For each eligible eye, the following procedure will be done in the "Exit visit" at the clinic:
- Bio-microscopy testing.
- Refraction correction by an optometrist.
- Habitual Snellen visual acuity
- Commercial OCT scanning using Zeiss Cirrus or Heidelberg Spectralis.
OCT scanning pattern:
- Macular cube of at least 6X6mm (20 degrees)
- At least 40 B-scans per cube NOTAL-OCT V3.0 Scanning. 6.Patient's experience questionnaire
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- AMD patients, where at least one eye is with active CNV, presenting retinal fluid at the enrolment visit, undergoing active anti-VEGF treatment
Key inclusion criteria (6 listed)
- Ability and willingness to give informed consent (IC)
- 18 years of age or older at the time of IC
- Tested eye(s) diagnosed with AMD
- Visual acuity of 20/400 Snellen (6/120) or better in the study eye
- At least one eye is with active CNV, presenting retinal fluid at the enrolment visit, undergoing active anti-VEGF treatment
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To describe the dynamics of retinal fluid
Time frame: 30 days
To describe the dynamics of retinal fluid in eyes undergoing anti-VEGF therapy as manifested in self-operated OCT in daily home testing
2 secondary outcomes
To evaluate patient experience when self-operating the Notal-OCT V3.0.
Time frame: 30 days
E. To evaluate the level of agreement between OCT images captured by Notal-OCT V3.0 and a commercial OCT
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
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.
michaela Glodstein, Dr principal investigator
Tel Aviv Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of A. AMD Patients, Where at Least One Eye is With Active CNV, Presenting Retinal Fluid at the Enrolment Visit, Undergoing Active Anti-VEGF Treatment, run by Notal Vision Ltd. at 1 site in Israel.
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 6 inclusion and 1 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: finished, as of the sponsor's last update on 15 Jun 2023. 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 Israel. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To describe the dynamics of retinal fluid (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2023.