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

Diabetic Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04254536
• Other study ID #: OCT-LOR-DME
• Status: Not yet recruiting
• Start date: February 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2020
• Source: Renmin Hospital of Wuhan University
• Contact: Hongmei Zheng, MD
• Phone: +86 13871484442
• Email: 13871484442[@]139.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: December 31, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Renmin Hospital of Wuhan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	best corrected visual acurity(BCVA)	Compare the changes of BCVA before treatment, 1 week after treatment and 1 month after treatment	2020-12
Primary	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	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