Wet Macular DegenerationNCT05211804
Mechanisms of Retinal Revascularization and Clinical Indicators of Neovascular AMD Relapse
An observational study of Wet Macular Degeneration, run by Sorlandet Hospital HF at 1 site in Norway.
Trial summary
Age-related macular degeneration (AMD) is a chronic and progressive eye disease and is one of the leading causes of vision impairment globally. AMD is referred to as either the dry or the wet type, where the wet type (also called neovascular-AMD or nAMD) is a later stage of the disease with neovascularization and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wet Macular Degeneration
- What is being tested?
- Ophthalmic Drugs
- How many people
- 31 participants
- Where
- 1 siteNorway
- Study dates
- 8 Feb 2022to 21 May 2024
- 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: Patients will be recruited from nAMD patients in the clinic at Eye dep. Sorlandet Hospital Arendal.
Who may be able to join
- Patients have to be 18 years or older
- Newly diagnosed nAMD (group 1) or nAMD treatment for at least 1 year (group 2), both with typical neovascular findings on OCT-A
- Patients with acceptable travel distance to the hospital
- Patients accepting to be part of the study
Who cannot join
- Other non-AMD macular disorders
- A spherical equivalent of -6 diopters or less
- Opacities of the visual axis; Changes of the cornea, anterior chamber, lens or vitreous cavity causing image acquisition artefacts
- Patients not able to attend extra controls due to age, illnesses or other factors
- Contraindications of intraocular injection therapy; Active ocular or periocular infection, active and serious intraocular inflammation, hypersensitivity to the drug or recent stroke / heart attack
Trial locations and contacts
1 site in 1 country.
About this study
Age-related macular degeneration (AMD) is a chronic and progressive eye disease and is one of the leading causes of vision impairment globally. AMD is referred to as either the dry or the wet type, where the wet type (also called neovascular-AMD or nAMD) is a later stage of the disease with neovascularization and retinal edema being the main attributes. This will usually cause subacute distortion or loss of central vision in patients. Since 2004, a successful treatment alternative for nAMD has been ocular injections with anti-VEGF (anti-Vascular Endothelial Growth Factor), causing the neovascularization and edema to regress and vision to improve. However, injections have to be repeated, usually requiring 8 injections or more during the first year of treatment. This can cause both a risk for serious adverse effects and is a significant financial drain on health care resources.
Patients undergoing treatment are at risk for retinal edema recurrence. The time interval tolerated between injections is individual, and the accepted treatment strategy of today is to gradually, in a stepwise manner, increase the interval between injections. For some patients this extension is well tolerated, but for many patients relapse of proliferations and retinal edema will recur. With state-of-the-art technology OCT-A (optical coherence tomography-angiography) in combination with the clinically, well established examination method of OCT (optical coherence tomography), the project group will study the phenotypic vessel and tissue changes that occur in between injections. Furthermore, the investigators will measure cytokines, chemokines and growth factors in blood samples and the tear film during different treatment stages to see if any single factor is prognostic for poorer response to treatment or relapse.
Read more
In the short term, the project group hope that the knowledge gained from this project could lead to a better understanding of the mechanisms behind nAMD neovascular relapse and to apply this to routine screening in the clinics. In the longer term, the project group hope that elucidating the physical mechanisms and molecular changes could enable new targeted therapies to be developed.
Aim 1: To characterize the phenotype of vessels in relapsing nAMD patients and compare to those without relapse using OCT-A imaging Aim 2: To investigate retinal edema and choroidal thickness in correlation with neovascular changes of relapsing nAMD Aim 3: To measure cytokines, chemokines and growth factors in the tear film before and during treatment with anti-VEGF for nAMD
With our main hypothesis being: Relapse of nAMD in patients occurs principally through reconfiguration and vasodilatation of persistent non-regressed vessels following anti-VEGF treatment, while fully regressed vessels remain dormant
- Conditions
- Wet Macular Degeneration
- Being tested
- Ophthalmic Drugs
- Keywords
- age related macular degeneration, age-related macular degeneration, wet age related macular degeneration, wet age-related macular degeneration, Optical Coherence Tomography Angiography, Optical Coherence Tomography, anti vascular endothelial growth factor, neovascular age related macular degeneration, neovascular age-related macular degeneration
- Medical subject headings
- Wet Macular Degeneration, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ophthalmic DrugsDrug
Also called Aflibercept, Bevacizumab, Ranibizumab
Patients will receive the same treatment as if not a part of the project
| Study group | Role | What they receive |
|---|---|---|
| Treatment-naïve | 15 patients not previously receiving anti-VEGF treatment for nAMD. Receives: Drug: Ophthalmic Drugs | |
| Undergoing treatment | 15 patients already undergoing treatment with anti-VEGF for nAMD. Receives: Drug: Ophthalmic Drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neovascular changes during nAMD relapse assessed by the use of Optical Coherence Tomography Angiography
Images gathered from OCTA imaging will be collected and vessel phenotype will be compared between different treatment stages to identify how vessels develop over time. The attributes that will be measured are feeder vessel thickness and to assess if new vessels develop "de novo" or by using old vessel pathways. The investigators intend to describe these findings and there are no planned metric measurements. This outcome is considered a descriptive, qualitative outcome.
Measured: 12 months after inclusion of patients
Secondary outcomes (3)
Choroidal thickness in nAMD patients undergoing treatment with anti-VEGF will be measured by the use of a caliper tool (metric scale) in the Optical Coherence Tomography software
Choroidal thickness will be measured by the use of a caliper tool in the OCTA software and the thickness measured will be compared between different treatment stages of nAMD.
Measured: 12 months after inclusion of patients
Tear film of nAMD patients at different treatment stages to be collected by Schirmers test and further biochemically analysed
Levels of cytokines, chemokines and growth factors will be compared between the different treatment stages of nAMD. This will also be compared to the different levels detected i blood samples done at the same time points. Only for the treatment-naïve group.
Measured: 12 months after inclusion of patients
Blood samples of nAMD patients at different treatment stages will be collected in microtubes and further biochemically analysed
Levels of cytokines, chemokines and growth factors will be compared between the different treatment stages of nAMD. This will also be compared to the different levels detected i tear samples done at the same time points. Only for the treatment-naïve group.
Measured: 12 months after inclusion of patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start8 Feb 2022
- Primary completion21 May 2024
- Study completion21 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wet 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Neil Lagali, Principal investigator, Sorlandet Hospital HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211804
- Sponsor's protocol ID
- 21-06505
- Status last verified
- Mar 2024
- First submitted
- 16 Dec 2021
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Currently there is not a plan to share individual data outside the project group due to confidentiality. If the investigators later would want to do this, new applications to the correct boards are needed.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Retinal Revascularization and Clinical Indicators of Neovascular AMD Relapse
- ClinicalTrials.gov ID
- NCT05211804
- Acronym / sponsor ID
- 21-06505
- Conditions
- Wet Macular Degeneration
- Keywords
- age related macular degeneration, age-related macular degeneration, wet age related macular degeneration, wet age-related macular degeneration, Optical Coherence Tomography Angiography, Optical Coherence Tomography, anti vascular endothelial growth factor, neovascular age related macular degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 21 May 2024 (actual)
- Study completion
- 21 May 2024 (actual)
- First posted
- 27 Jan 2022 (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.
Age-related macular degeneration (AMD) is a chronic and progressive eye disease and is one of the leading causes of vision impairment globally. AMD is referred to as either the dry or the wet type, where the wet type (also called neovascular-AMD or nAMD) is a later stage of the disease with neovascularization and retinal edema being the main attributes. This will usually cause subacute distortion or loss of central vision in patients. Since 2004, a successful treatment alternative for nAMD has been ocular injections with anti-VEGF (anti-Vascular Endothelial Growth Factor), causing the neovascularization and edema to regress and vision to improve. However, injections have to be repeated, usually requiring 8 injections or more during the first year of treatment. This can cause both a risk for serious adverse effects and is a significant financial drain on health care resources.
Patients undergoing treatment are at risk for retinal edema recurrence. The time interval tolerated between injections is individual, and the accepted treatment strategy of today is to gradually, in a stepwise manner, increase the interval between injections. For some patients this extension is well tolerated, but for many patients relapse of proliferations and retinal edema will recur. With state-of-the-art technology OCT-A (optical coherence tomography-angiography) in combination with the clinically, well established examination method of OCT (optical coherence tomography), the project group will study the phenotypic vessel and tissue changes that occur in between injections. Furthermore, the investigators will measure cytokines, chemokines and growth factors in blood samples and the tear film during different treatment stages to see if any single factor is prognostic for poorer response to treatment or relapse.
In the short term, the project group hope that the knowledge gained from this project could lead to a better understanding of the mechanisms behind nAMD neovascular relapse and to apply this to routine screening in the clinics. In the longer term, the project group hope that elucidating the physical mechanisms and molecular changes could enable new targeted therapies to be developed.
Aim 1: To characterize the phenotype of vessels in relapsing nAMD patients and compare to those without relapse using OCT-A imaging Aim 2: To investigate retinal edema and choroidal thickness in correlation with neovascular changes of relapsing nAMD Aim 3: To measure cytokines, chemokines and growth factors in the tear film before and during treatment with anti-VEGF for nAMD
With our main hypothesis being: Relapse of nAMD in patients occurs principally through reconfiguration and vasodilatation of persistent non-regressed vessels following anti-VEGF treatment, while fully regressed vessels remain dormant
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment-naïve | – | Drug: Ophthalmic Drugs15 patients not previously receiving anti-VEGF treatment for nAMD. |
| Undergoing treatment | – | Drug: Ophthalmic Drugs15 patients already undergoing treatment with anti-VEGF for nAMD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from nAMD patients in the clinic at Eye dep. Sorlandet Hospital Arendal.
Key inclusion criteria (4 listed)
- Patients have to be 18 years or older
- Newly diagnosed nAMD (group 1) or nAMD treatment for at least 1 year (group 2), both with typical neovascular findings on OCT-A
- Patients with acceptable travel distance to the hospital
- Patients accepting to be part of the study
Key exclusion criteria (5 listed)
- Other non-AMD macular disorders
- A spherical equivalent of -6 diopters or less
- Opacities of the visual axis; Changes of the cornea, anterior chamber, lens or vitreous cavity causing image acquisition artefacts
- Patients not able to attend extra controls due to age, illnesses or other factors
- Contraindications of intraocular injection therapy; Active ocular or periocular infection, active and serious intraocular inflammation, hypersensitivity to the drug or recent stroke / heart attack
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 |
|---|---|---|
| Ophthalmic DrugsAlso: Aflibercept, Bevacizumab, RanibizumabPatients will receive the same treatment as if not a part of the project | Drug | Treatment-naïve, Undergoing treatment |
Primary outcome
Neovascular changes during nAMD relapse assessed by the use of Optical Coherence Tomography Angiography
Time frame: 12 months after inclusion of patients
Images gathered from OCTA imaging will be collected and vessel phenotype will be compared between different treatment stages to identify how vessels develop over time. The attributes that will be measured are feeder vessel thickness and to assess if new vessels develop "de novo" or by using old vessel pathways. The investigators intend to describe these findings and there are no planned metric measurements. This outcome is considered a descriptive, qualitative outcome.
3 secondary outcomes
Choroidal thickness in nAMD patients undergoing treatment with anti-VEGF will be measured by the use of a caliper tool (metric scale) in the Optical Coherence Tomography software
Time frame: 12 months after inclusion of patients
Tear film of nAMD patients at different treatment stages to be collected by Schirmers test and further biochemically analysed
Time frame: 12 months after inclusion of patients
Blood samples of nAMD patients at different treatment stages will be collected in microtubes and further biochemically analysed
Time frame: 12 months after inclusion of patients
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 5 Jun 2024.
- Individual participant dataSharing planned: Undecided. Currently there is not a plan to share individual data outside the project group due to confidentiality. If the investigators later would want to do this, new applications to the correct boards are needed.
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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.
Neil Lagali principal investigator
Sorlandet Hospital HF
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 Wet Macular Degeneration, run by Sorlandet Hospital HF at 1 site in Norway.
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 5 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 5 Jun 2024. 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 Norway. 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?
Neovascular changes during nAMD relapse assessed by the use of Optical Coherence Tomography Angiography (time frame: 12 months after inclusion of patients). 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 5 Jun 2024.