Age-Related Macular DegenerationNCT03374020
Retinal Imaging Using NOTAL-OCT
An observational study of Age-Related Macular Degeneration and Diabetic Retinopathy, run by Notal Vision Ltd..
Trial summary
Comparison between retinal measurements, done by the Notal-OCT imaging and a commercial OCT (Optical Coherence Tomography) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Age-Related Macular Degeneration, Diabetic Retinopathy
- What is being tested?
- Notal OCT
- Type of treatment
- Medical device
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 17 Jan 2017to 1 Dec 2018
- 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: 1. AMD population - intermediate and advanced AMD (with active and non-active CNV) 2. DR population. Patient with and without DME
Who may be able to join
- Ability and agreement to give informed consent (IC)
- Diagnosis of AMD or DR in SE by OCT
- Ability to undergo OCT scans
- VA of 20/160 or better in SE
Who cannot join
- AMD and DR in the same SE
- Evidence of macular disease other than AMD or DME in SE
About this study
Comparison between retinal measurements, done by the Notal-OCT imaging and a commercial OCT (Optical Coherence Tomography)
- Being tested
- Notal OCT
- Medical subject headings
- Macular Degeneration, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Notal OCTDevice
Imaging using Notal OCT
| Study group | Role | What they receive |
|---|---|---|
| Intermediate AMD | Not described Receives: Device: Notal OCT | |
| Advanced AMD | Not described Receives: Device: Notal OCT | |
| DR without macular edema | Not described Receives: Device: Notal OCT | |
| DR with macular edema | Not described Receives: Device: Notal OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of agreement between NOTAL-OCT and commercial OCT in detecting fluid in the 10 central degrees of the macula.
OCT B-scans from both devices will be graded for fluid by an eye care professional and results per macula will be analyzed. A binary decision "there is fluid" or "there is no fluid" will be given to each macula (10 central degrees). Then agreement between decisions, commercial and Notal OCT, will be compared
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start17 Jan 2017
- Primary completion14 May 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies 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
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Notal Vision Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374020
- Sponsor's protocol ID
- BNZ-0077-017
- Status last verified
- Oct 2020
- First submitted
- 11 Sep 2017
- Last updated
- 13 Nov 2020
- 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 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Imaging Using NOTAL-OCT
- ClinicalTrials.gov ID
- NCT03374020
- Acronym / sponsor ID
- BNZ-0077-017
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Notal Vision Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- 14 May 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 14 Dec 2017 (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.
Comparison between retinal measurements, done by the Notal-OCT imaging and a commercial OCT (Optical Coherence Tomography)
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intermediate AMD | – | Device: Notal OCT |
| Advanced AMD | – | Device: Notal OCT |
| DR without macular edema | – | Device: Notal OCT |
| DR with macular edema | – | Device: Notal OCT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. AMD population - intermediate and advanced AMD (with active and non-active CNV) 2. DR population. Patient with and without DME
Key inclusion criteria (4 listed)
- Ability and agreement to give informed consent (IC)
- Diagnosis of AMD or DR in SE by OCT
- Ability to undergo OCT scans
- VA of 20/160 or better in SE
Key exclusion criteria (2 listed)
- AMD and DR in the same SE
- Evidence of macular disease other than AMD or DME in SE
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 |
|---|---|---|
| Notal OCTImaging using Notal OCT | Device | Advanced AMD, DR with macular edema, DR without macular edema, Intermediate AMD |
Primary outcome
The level of agreement between NOTAL-OCT and commercial OCT in detecting fluid in the 10 central degrees of the macula.
Time frame: 1 year
OCT B-scans from both devices will be graded for fluid by an eye care professional and results per macula will be analyzed. A binary decision "there is fluid" or "there is no fluid" will be given to each macula (10 central degrees). Then agreement between decisions, commercial and Notal OCT, will be compared
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 13 Nov 2020.
Related trials for Age-Related Macular Degeneration
RecruitingPhase 1
A Study About the Safety of a Single ASP2020 Eye Injection and if it Helps People With Vision Loss From Stargardt-type Eye Conditions
Stargardt Disease, Stargardt Macular Dystrophy
RecruitingPhase 1/2
Safety and Efficacy of Oral HX9428 Tablets in Subjects With Wet Age-related Macular Degeneration (wAMD)
Wet Age-related Macular Degeneration (AMD)
Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
Neovascular Age-related Macular Degeneration
RecruitingPhase 3
Extension Study for the Port Delivery System With Ranibizumab (Portal)
Neovascular Age-Related Macular Degeneration
RecruitingPhase 3
Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)
Neovascular Age-related Macular Degeneration
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-Related Macular Degeneration and Diabetic Retinopathy, run by Notal Vision Ltd..
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 4 inclusion and 2 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 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The level of agreement between NOTAL-OCT and commercial OCT in detecting fluid in the 10 central degrees of the macula. (time frame: 1 year). 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 13 Nov 2020.