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

• Conditions: Diabetic Macular Edema

• Registration Number: NCT04254536
• Lead Sponsor: Renmin Hospital of Wuhan University

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

Study Timeline

• Status Verified: 2020-01
• Study Start: 2020-02-01
• Study First Submitted: 2020-02-02
• Study First Submitted QC: 2020-02-02
• Last Update Submitted: 2020-02-02
• Study First Posted: 2020-02-05
• Last Update Posted: 2020-02-05
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 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）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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
central retinal thickness（CRT）	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
low optical ratio(LOR)	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
best corrected visual acurity(BCVA)	2020-12	Compare the changes of BCVA before treatment, 1 week after treatment and 1 month after treatment

Secondary Outcome Measures

Name	Time	Method
Ellipsoid Zone	2020-12	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