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

NCT ID: NCT04254536

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-01

Study Completion Date

2020-12-31

Brief Summary

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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

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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

Conditions

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Diabetic Macular Edema

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Renmin Hospital of Wuhan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Hongmei Zheng, MD

Role: CONTACT

+86 13871484442

Jingwen Jiang

Role: CONTACT

+86 15623512305

Other Identifiers

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OCT-LOR-DME

Identifier Type: -

Identifier Source: org_study_id

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