Clinical trial NCT04254536: Changes in Optical Coherence Tomography Leakage Mapping in Diabetic Macular Edema After Conbercept Treatment
Official title: Changes in Optical Coherence Tomography Leakage Mapping in Diabetic Macular Edema Before and After Treatment With Conbercept
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Macular Edema
Keywords: diebetic macular edema
optical coherence tomography
conbercept
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diabetic macular edema in the Renmin Hospital of Wuhan University during the study period

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

Eligibility criteria: 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

Primary outcomes:
measure: central retinal thickness（CRT）
timeFrame: 2020-12
measure: best corrected visual acurity(BCVA)
timeFrame: 2020-12
measure: low optical ratio(LOR)
timeFrame: 2020-12
Secondary outcomes:
measure: Ellipsoid Zone
timeFrame: 2020-12
Other outcomes:
Locations:
Study officials:
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