Neovascular Age-related Macular DegenerationDANANCT03909425
Defining Disease Activity in Neovascular AMD With Optical Coherence Tomography Angiography
An observational study of Neovascular Age-related Macular Degeneration, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The purpose of this study is to be able to describe optical coherence angiography (OCTA) patterns of disease activity and quiescence in eyes that have received treatment. The target population group is patients that have neovascular age-related macular degeneration and have had treatment with aflibercept for this… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Sep 2019to 16 Aug 2021
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with nAMD attending Moorfields Eye Hospital who show no signs of disease activity after treatment with anti-VEGF injections (no signs of macular fluid or macular haemorrhage).
Who may be able to join
- Patients over 50 years of age with a diagnosis of nAMD receiving anti-VEGF treatment with no signs of intra-or subretinal fluid on structural OCT imaging and with no macular haemorrhage after a minimum of three intravitreal injections
- Visual acuity in the study eye of 35 Early Treatment of Diabetic Retinopathy Study (ETDRS) letter score or better (6/60 or better)
- Ability to understand the nature/purpose of the study and to provide informed consent
- Any ocular condition which would lead to image artefact or poor OCT image quality
- Ability to undergo retinal imaging
Who cannot join
- Patients with polypoidal choroidal vasculopathy or pachychoroid
- Patients in whom imaging of the study eye leads to ungradable OCTA images.
- Any condition which, in the investigators' opinion, would conflict or otherwise prevent the subject from complying with the required procedures, schedule or other study conduct.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Moorfields Eye Hospital NHS Foundation Trust, 162 City Road
London, EC1V 2PD
About this study
Official title: Defining Disease Activity in Neovascular Age-related Macular Degeneration With Optical Coherence Tomography Angiography - A Prospective, Imaging Study - The DANA Study
The purpose of this study is to be able to describe optical coherence angiography (OCTA) patterns of disease activity and quiescence in eyes that have received treatment. The target population group is patients that have neovascular age-related macular degeneration and have had treatment with aflibercept for this condition.
This is a single-site study and does not involve any masking or treatment allocation.
Read the detailed description
Treatment of this condition (neovascular age-related macular degeneration - nAMD) with aflibercept has transformed the outlook for patients with this sight-threatening disease.
In clinical practice, eye doctors commonly use a "treat and extend" approach to treatment in which the interval between aflibercept injections is gradually increased once there is nAMD disease quiescence.
It is uncertain about the ideal retinal imaging biomarkers doctors should use to define disease remission or inactivity; and therefore extend treatment intervals. Increased certainty of the ideal biomarker would also avoid stopping treatment too soon.
The scan the investigators will be performing (OCTA imaging) detects blood flow within the choroidal neovascular membrane (CNV) - the immature blood vessel network which causes nAMD. This scan is therefore a potentially powerful way of determining if the disease is active or quiescent. Disease activity on this device can be defined as a blood flow pattern which suggests an active CNV or lesion growth.
By better defining disease activity using OCTA, eye doctors would be more confident in continuing and defining a treatment plan for nAMD.
- Keywords
- nAMD, Treat and Extend, Aflibercept, OCTA, Neovascular age-related macular degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants treated nAMD
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0, Change From Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start2 Sep 2019
- Primary completion16 Aug 2021
- Study completion16 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Praveen J Patel, FRCOphth, MD, Principal investigator, Moorfields Eye Hosptial NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909425
- Sponsor's protocol ID
- PATP1032
- Acronym
- DANA
- Status last verified
- Nov 2023
- First submitted
- 8 Apr 2019
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Disease Activity in Neovascular Age-related Macular Degeneration With Optical Coherence Tomography Angiography - A Prospective, Imaging Study - The DANA Study
- ClinicalTrials.gov ID
- NCT03909425
- Acronym / sponsor ID
- DANA / PATP1032
- Keywords
- nAMD, Treat and Extend, Aflibercept, OCTA, Neovascular age-related macular degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 16 Aug 2021 (actual)
- Study completion
- 16 Aug 2021 (actual)
- First posted
- 10 Apr 2019 (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 purpose of this study is to be able to describe optical coherence angiography (OCTA) patterns of disease activity and quiescence in eyes that have received treatment. The target population group is patients that have neovascular age-related macular degeneration and have had treatment with aflibercept for this condition.
This is a single-site study and does not involve any masking or treatment allocation.
Detailed description
Treatment of this condition (neovascular age-related macular degeneration - nAMD) with aflibercept has transformed the outlook for patients with this sight-threatening disease.
In clinical practice, eye doctors commonly use a "treat and extend" approach to treatment in which the interval between aflibercept injections is gradually increased once there is nAMD disease quiescence.
It is uncertain about the ideal retinal imaging biomarkers doctors should use to define disease remission or inactivity; and therefore extend treatment intervals. Increased certainty of the ideal biomarker would also avoid stopping treatment too soon.
The scan the investigators will be performing (OCTA imaging) detects blood flow within the choroidal neovascular membrane (CNV) - the immature blood vessel network which causes nAMD. This scan is therefore a potentially powerful way of determining if the disease is active or quiescent. Disease activity on this device can be defined as a blood flow pattern which suggests an active CNV or lesion growth.
By better defining disease activity using OCTA, eye doctors would be more confident in continuing and defining a treatment plan for nAMD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with nAMD attending Moorfields Eye Hospital who show no signs of disease activity after treatment with anti-VEGF injections (no signs of macular fluid or macular haemorrhage).
Key inclusion criteria (5 listed)
- Patients over 50 years of age with a diagnosis of nAMD receiving anti-VEGF treatment with no signs of intra-or subretinal fluid on structural OCT imaging and with no macular haemorrhage after a minimum of three intravitreal injections
- Visual acuity in the study eye of 35 Early Treatment of Diabetic Retinopathy Study (ETDRS) letter score or better (6/60 or better)
- Ability to understand the nature/purpose of the study and to provide informed consent
- Any ocular condition which would lead to image artefact or poor OCT image quality
- Ability to undergo retinal imaging
Key exclusion criteria (3 listed)
- Patients with polypoidal choroidal vasculopathy or pachychoroid
- Patients in whom imaging of the study eye leads to ungradable OCTA images.
- Any condition which, in the investigators' opinion, would conflict or otherwise prevent the subject from complying with the required procedures, schedule or other study conduct.
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
Number of participants treated nAMD
Time frame: 18 Months
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0, Change From Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks
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 30 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Praveen J Patel, FRCOphth, MD principal investigator
Moorfields Eye Hosptial NHS Foundation Trust
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 Neovascular Age-related Macular Degeneration, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
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 5 inclusion and 3 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 30 Nov 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 United Kingdom. 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?
Number of participants treated nAMD (time frame: 18 Months). 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 30 Nov 2023.