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Changes in Optical Coherence Tomography Leakage Mapping in Diabetic Macular Edema After Conbercept Treatment

Changes in Optical Coherence Tomography Leakage Mapping in Diabetic Macular Edema Before and After Treatment With Conbercept

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04254536
Enrollment
35
Registered
2020-02-05
Start date
2020-02-01
Completion date
2020-12-31
Last updated
2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema

Keywords

diebetic macular edema, optical coherence tomography, conbercept

Brief 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). 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

1. 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. 2. Subjects Number of subjects planned to be recruited: 35 Inclusion criteria: 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 Exclusion criteria: 1. High myopia 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 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

Interventions

None listed

Sponsors

Renmin Hospital of Wuhan University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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 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

Design outcomes

Primary

MeasureTime frameDescription
central retinal thickness(CRT)2020-12CRT 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)2020-12Compare the changes of BCVA before treatment, 1 week after treatment and 1 month after treatment
low optical ratio(LOR)2020-12The 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

Secondary

MeasureTime frameDescription
Ellipsoid Zone2020-12The 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

Contacts

Primary ContactHongmei Zheng, MD
13871484442@139.com+86 13871484442
Backup ContactJingwen Jiang
568314041@qq.com+86 15623512305

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026