Choroidal NeovascularizationNCT06243406
Study on the Biomarkers of Anti-VEGF Treatment for Choroidal Neovascularization
An observational study of Choroidal Neovascularization, run by Beijing Hospital.
Trial summary
Choroidal neovascularization (CNV), also known as subretinal neovascularization, is a proliferative change from choroidal capillaries that has become one of the most important causes of blindness worldwide. CNV can occur in a variety of fundus diseases, including pathologic myopia, polypoidal choroidal vasculopathy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Choroidal Neovascularization
- What is being tested?
- Intravitreal injection of anti-VEGF
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2024to Oct 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 to 90 years
- All sexes
- Adult, Older adult
Study population: Patients diagnosed with choroidal neovascularization, who received standard 3-monthly anti-VEGF treatment.
Who may be able to join
- Age >18 years old
- Active choroidal neovascularization (activity criteria: blood vessel leakage confirmed by FFA, or subretinal fluid accumulation or bleeding seen by OCT)
- History of anti-VEGF drug therapy
- At least 3 months of follow-up data.
Who cannot join
- Unable to complete the examination due to severe cataract or vitreous hemorrhage
- Any retinal diseases except choroidal neovascularization, such as multifocal choroiditis, diabetic retinopathy
- History of intraocular surgery
About this study
Official title: Study on the Biomarkers to Predict the Response to Anti-vascular Endothelial Growth Factor Treatment for Choroidal Neovascularization
Choroidal neovascularization (CNV), also known as subretinal neovascularization, is a proliferative change from choroidal capillaries that has become one of the most important causes of blindness worldwide. CNV can occur in a variety of fundus diseases, including pathologic myopia, polypoidal choroidal vasculopathy. At present, intravitreal injection of anti-vascular endothelial growth factor (VEGF) drugs is the first-line effective treatment for CNV. Although a number of clinical studies have shown that the treatment of CNV with anti-VEGF drugs has achieved good visual and anatomical effects, there are still some patients whose CNV has not decreased significantly or even progressed continuously after treatment. Rapid advances in imaging technology have made it possible to explore the quantitative and qualitative characteristics of choroid and CNV, especially swept source optical coherence tomography angiography (SS-OCTA).
The objectives are to improve the OCTA typing of CNV and analyze the vascular morphological characteristics of each type; to identify the changes in vascular characteristics of CNV after anti-VEGF treatment in vitreous cavity; and to elucidate the predictive effects of neovascularization and choroidal vascular characteristics on visual acuity and anatomic effects of vitreous anti-VEGF drug treatment for CNV.
- Conditions
- Choroidal Neovascularization
- Being tested
- Intravitreal injection of anti-VEGF
- Medical subject headings
- Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal injection of anti-VEGFOther
Intravitreal injection of anti- vascular endothelial growth factor (VEGF) treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
choroidal thickness
central choroidal thickness measured by SS-OCTA
Measured: 3 months
Central retinal thickness
central retinal thickness changes measured by SS-OCTA
Measured: 3 months
Best-corrected visual acuity
Best-corrected visual acuity changes from baseline to 3 months
Measured: 3 months
Secondary outcomes (1)
choroidal vascularity index
the ratio of vascular area to the total choroidal area measured by SS-OCTA
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start10 Feb 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choroidal NeovascularizationStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243406
- Sponsor's protocol ID
- BJ-2022-012
- Status last verified
- Feb 2024
- First submitted
- 29 Jan 2024
- Last updated
- 7 Feb 2024
- Results posted
- 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 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Biomarkers to Predict the Response to Anti-vascular Endothelial Growth Factor Treatment for Choroidal Neovascularization
- ClinicalTrials.gov ID
- NCT06243406
- Acronym / sponsor ID
- BJ-2022-012
- Conditions
- Choroidal Neovascularization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Beijing HospitalOther government
- Study start
- 10 Feb 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 6 Feb 2024 (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.
Choroidal neovascularization (CNV), also known as subretinal neovascularization, is a proliferative change from choroidal capillaries that has become one of the most important causes of blindness worldwide. CNV can occur in a variety of fundus diseases, including pathologic myopia, polypoidal choroidal vasculopathy. At present, intravitreal injection of anti-vascular endothelial growth factor (VEGF) drugs is the first-line effective treatment for CNV. Although a number of clinical studies have shown that the treatment of CNV with anti-VEGF drugs has achieved good visual and anatomical effects, there are still some patients whose CNV has not decreased significantly or even progressed continuously after treatment. Rapid advances in imaging technology have made it possible to explore the quantitative and qualitative characteristics of choroid and CNV, especially swept source optical coherence tomography angiography (SS-OCTA).
The objectives are to improve the OCTA typing of CNV and analyze the vascular morphological characteristics of each type; to identify the changes in vascular characteristics of CNV after anti-VEGF treatment in vitreous cavity; and to elucidate the predictive effects of neovascularization and choroidal vascular characteristics on visual acuity and anatomic effects of vitreous anti-VEGF drug treatment for CNV.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with choroidal neovascularization, who received standard 3-monthly anti-VEGF treatment.
Key inclusion criteria (4 listed)
- Age >18 years old
- Active choroidal neovascularization (activity criteria: blood vessel leakage confirmed by FFA, or subretinal fluid accumulation or bleeding seen by OCT)
- History of anti-VEGF drug therapy
- At least 3 months of follow-up data.
Key exclusion criteria (3 listed)
- Unable to complete the examination due to severe cataract or vitreous hemorrhage
- Any retinal diseases except choroidal neovascularization, such as multifocal choroiditis, diabetic retinopathy
- History of intraocular surgery
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 |
|---|---|---|
| Intravitreal injection of anti-VEGFIntravitreal injection of anti- vascular endothelial growth factor (VEGF) treatment | Other | – |
Primary outcome
choroidal thickness
Time frame: 3 months
central choroidal thickness measured by SS-OCTA
Central retinal thickness
Time frame: 3 months
central retinal thickness changes measured by SS-OCTA
Best-corrected visual acuity
Time frame: 3 months
Best-corrected visual acuity changes from baseline to 3 months
1 secondary outcome
choroidal vascularity index
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- 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.
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 Choroidal Neovascularization, run by Beijing Hospital.
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 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: status not confirmed, as of the sponsor's last update on 7 Feb 2024. 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?
Results are not available in the source record.
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?
choroidal thickness (time frame: 3 months). The study lists 3 primary outcomes in all. 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 7 Feb 2024.