Age-Related Macular DegenerationNCT03030729
Macular Thickness Measurements Using Retinal-thickness OCT
An observational study of Age-Related Macular Degeneration and Diabetic Retinopathy, run by Notal Vision Ltd. at 1 site in Israel.
Trial summary
Comparison between retinal measurements, done by the RT (Retinal Thickness) 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
- How many people
- 14 participants
- Where
- 1 siteIsrael
- Study dates
- 14 Mar 2017to 14 Jan 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
Who cannot join
- AMD and DR in the same SE
- Evidence of macular disease other than AMD or DME in SE
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Macular Thickness Measurements Using RTOCT
Comparison between retinal measurements, done by the RT (Retinal Thickness) imaging and a commercial OCT (Optical Coherence Tomography)
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Intermediate AMD | Not described | |
| Advanced AMD | Not described | |
| DR without macular edema | Not described | |
| DR with macular edema | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between retinal measurements, done by the RTOCT device and a commercial OCT
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 posted25 Jan 2017 (estimated)
- Study start14 Mar 2017
- Primary completion14 Jan 2018
- Study completion14 Jan 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Notal Vision Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030729
- Sponsor's protocol ID
- TLV-0025-16
- Status last verified
- Jan 2017
- First submitted
- 23 Jan 2017
- Last updated
- 17 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macular Thickness Measurements Using RTOCT
- ClinicalTrials.gov ID
- NCT03030729
- Acronym / sponsor ID
- TLV-0025-16
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Notal Vision Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Mar 2017 (actual)
- Primary completion
- 14 Jan 2018 (actual)
- Study completion
- 14 Jan 2018 (actual)
- First posted
- 25 Jan 2017 (estimated)
- 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 RT (Retinal Thickness) 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 | – | – |
| Advanced AMD | – | – |
| DR without macular edema | – | – |
| DR with macular edema | – | – |
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 (3 listed)
- Ability and agreement to give informed consent (IC)
- Diagnosis of AMD or DR in SE by OCT
- Ability to undergo OCT scans
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.
Primary outcome
Comparison between retinal measurements, done by the RTOCT device and a commercial OCT
Time frame: 1 year
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 17 Jun 2019.
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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.
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 Age-Related Macular Degeneration and Diabetic Retinopathy, 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 3 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 17 Jun 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 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?
Comparison between retinal measurements, done by the RTOCT device and a commercial OCT (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 17 Jun 2019.