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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetic Macular Edema

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 Type: Observational
• Enrollment (Anticipated): 35

Contacts and Locations

• Study Contact: Name: Hongmei Zheng, MD; Phone Number: +86 13871484442; Email: 13871484442@139.com
• Study Contact Backup: Name: Jingwen Jiang; Phone Number: +86 15623512305; Email: 568314041@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with diabetic macular edema in the Renmin Hospital of Wuhan University during the study period

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ellipsoid Zone	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	2020-12

Collaborators and Investigators

• Sponsor: Renmin Hospital of Wuhan University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: February 2, 2020
• First Submitted That Met QC Criteria: February 2, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 2, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: optical coherence tomography; conbercept; diebetic macular edema
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema
• Other Study ID Numbers: OCT-LOR-DME

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No