Changes in Optical Coherence Tomography Leakage Mapping in Diabetic Macular Edema After Conbercept Treatment
1 other identifier
observational
35
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2020
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2020
CompletedFirst Submitted
Initial submission to the registry
February 2, 2020
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedFebruary 5, 2020
January 1, 2020
10 months
February 2, 2020
February 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
2020-12
best corrected visual acurity(BCVA)
Compare the changes of BCVA before treatment, 1 week after treatment and 1 month after treatment
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
2020-12
Secondary Outcomes (1)
Ellipsoid Zone
2020-12
Eligibility Criteria
Patients with diabetic macular edema in the Renmin Hospital of Wuhan University during the study period
You may qualify if:
- ）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
You may not qualify if:
- ）Myopia ≥ 6.0D
- \) 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2020
First Posted
February 5, 2020
Study Start
February 1, 2020
Primary Completion
December 1, 2020
Study Completion
December 31, 2020
Last Updated
February 5, 2020
Record last verified: 2020-01