Diabetic Macular EdemaNCT04254536
Changes in Optical Coherence Tomography Leakage Mapping in Diabetic Macular Edema After Conbercept Treatment
An observational study of Diabetic Macular Edema, run by Renmin Hospital of Wuhan University.
Trial summary
Eyes with diabetic macular edema requiring conbercept treatment will be followed up for one month. Before treatment, one week after treatment and one month after treatment, the eyes will be examined by optical coherence tomography (OCT) and optical coherence tomographic angiography (OCTA). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Macular Edema
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2020to 31 Dec 2020
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diabetic macular edema in the Renmin Hospital of Wuhan University during the study period
Who may be able to join
- 1）Age ≥ 18
- 2) Diabetic macular edema eyes treated with conbercept for the first time in 1 week
- 3) Informed consent of patients and signing of informed consent
Who cannot join
- 1）Myopia ≥ 6.0D
- 2) Macular diseases affecting vision
- 3) Vitreous hemorrhage requiring surgery
- 4) Patients with anterior segment neovascularization
- 5) Eye or periocular infection
- 6) Optic neuropathy and glaucoma
Show all 10Show fewer
- 7) Periphlebitis, ophthalmic ischemic syndrome, uveitis, coat's disease, FEVR and other retinal diseases
- 8) Ametropia and cataract surgery
- 9) In 3 months, in addition to this treatment of conbercept, other anti VEGF treatment, laser treatment or vitreoretinal surgery were performed
- 10) Other systemic diseases can not complete follow-up
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Changes in Optical Coherence Tomography Leakage Mapping in Diabetic Macular Edema Before and After Treatment With Conbercept
Eyes with diabetic macular edema requiring conbercept treatment will be followed up for one month. Before treatment, one week after treatment and one month after treatment, the eyes will be examined by optical coherence tomography (OCT) and optical coherence tomographic angiography (OCTA). The changes of macular edema will be observed and analyzed by OCT leakage mapping software, and the relationship between the changes of macular edema and visual acuity will be analyzed.
Read the detailed description
- Research purpose: After one month follow-up, we will observe whether OCTleakage mapping can be used as a biomarker to predict the prognosis of DME eyes, and will observe the effect of Conbercept on improving edema and visual acuity of DME eyes.
- Subjects Number of subjects planned to be recruited: 35
Inclusion criteria:
- Age ≥ 18
- Diabetic macular edema eyes treated with conbercept for the first time in 1 week
- Informed consent of patients and signing of informed consent
Exclusion criteria:
- High myopia
- Macular diseases affecting vision
- Vitreous hemorrhage requiring surgery
- Patients with anterior segment neovascularization
- Eye or periocular infection
- Optic neuropathy and glaucoma
- Periphlebitis, ophthalmic ischemic syndrome, uveitis, coat's disease, FEVR and other retinal diseases
- Ametropia and cataract surgery
- In 3 months, in addition to this treatment of conbercept, other anti VEGF treatment, laser treatment or vitreoretinal surgery were performed
- Other systemic diseases can not complete follow-up
- Conditions
- Diabetic Macular Edema
- Keywords
- diebetic macular edema, optical coherence tomography, conbercept
What is being measured
The primary outcome is the main question the study is designed to answer.
central retinal thickness（CRT）
CRT will be measured by OCT software and the changes before treatment, 1 week after treatment and 1 month after treatment will be compared
Measured: 2020-12
best corrected visual acurity(BCVA)
Compare the changes of BCVA before treatment, 1 week after treatment and 1 month after treatment
Measured: 2020-12
low optical ratio(LOR)
The image will be processed by OCT leakage mapping software, and the changes of LOR will compared before treatment, 1 week after treatment and 1 month after treatment
Measured: 2020-12
Secondary outcomes (1)
Ellipsoid Zone
The continuity of EZ will be judged by OCT image processing, and the changes before treatment, 1 week after treatment and 1 month after treatment will be compared
Measured: 2020-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Feb 2020 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies 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
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254536
- Sponsor's protocol ID
- OCT-LOR-DME
- Status last verified
- Jan 2020
- First submitted
- 2 Feb 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Optical Coherence Tomography Leakage Mapping in Diabetic Macular Edema Before and After Treatment With Conbercept
- ClinicalTrials.gov ID
- NCT04254536
- Acronym / sponsor ID
- OCT-LOR-DME
- Conditions
- Diabetic Macular Edema
- Keywords
- diebetic macular edema, optical coherence tomography, conbercept
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 5 Feb 2020 (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.
Eyes with diabetic macular edema requiring conbercept treatment will be followed up for one month. Before treatment, one week after treatment and one month after treatment, the eyes will be examined by optical coherence tomography (OCT) and optical coherence tomographic angiography (OCTA). The changes of macular edema will be observed and analyzed by OCT leakage mapping software, and the relationship between the changes of macular edema and visual acuity will be analyzed.
Detailed description
- Research purpose: After one month follow-up, we will observe whether OCTleakage mapping can be used as a biomarker to predict the prognosis of DME eyes, and will observe the effect of Conbercept on improving edema and visual acuity of DME eyes.
- Subjects Number of subjects planned to be recruited: 35
Inclusion criteria:
- Age ≥ 18
- Diabetic macular edema eyes treated with conbercept for the first time in 1 week
- Informed consent of patients and signing of informed consent
Exclusion criteria:
- High myopia
- Macular diseases affecting vision
- Vitreous hemorrhage requiring surgery
- Patients with anterior segment neovascularization
- Eye or periocular infection
- Optic neuropathy and glaucoma
- Periphlebitis, ophthalmic ischemic syndrome, uveitis, coat's disease, FEVR and other retinal diseases
- Ametropia and cataract surgery
- In 3 months, in addition to this treatment of conbercept, other anti VEGF treatment, laser treatment or vitreoretinal surgery were performed
- Other systemic diseases can not complete follow-up
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diabetic macular edema in the Renmin Hospital of Wuhan University during the study period
Key inclusion criteria (3 listed)
- 1）Age ≥ 18
- 2) Diabetic macular edema eyes treated with conbercept for the first time in 1 week
- 3) Informed consent of patients and signing of informed consent
Key exclusion criteria (10 listed)
- 1）Myopia ≥ 6.0D
- 2) Macular diseases affecting vision
- 3) Vitreous hemorrhage requiring surgery
- 4) Patients with anterior segment neovascularization
- 5) Eye or periocular infection
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
central retinal thickness（CRT）
Time frame: 2020-12
CRT will be measured by OCT software and the changes before treatment, 1 week after treatment and 1 month after treatment will be compared
best corrected visual acurity(BCVA)
Time frame: 2020-12
Compare the changes of BCVA before treatment, 1 week after treatment and 1 month after treatment
low optical ratio(LOR)
Time frame: 2020-12
The image will be processed by OCT leakage mapping software, and the changes of LOR will compared before treatment, 1 week after treatment and 1 month after treatment
1 secondary outcome
Ellipsoid Zone
Time frame: 2020-12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Macular Edema, run by Renmin Hospital of Wuhan University.
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 10 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 5 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongmei Zheng, MD (+86 13871484442, 13871484442@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
central retinal thickness（CRT） (time frame: 2020-12). 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 5 Feb 2020.