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

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ClinicalTrials.gov Identifier: NCT04254536
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Renmin Hospital of Wuhan University

Study Description
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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.

Condition or disease
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 Design
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Study Type : Observational
Estimated Enrollment : 35 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Changes in Optical Coherence Tomography Leakage Mapping in Diabetic Macular Edema Before and After Treatment With Conbercept
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. central retinal thickness（CRT） [ Time Frame: 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

  2. best corrected visual acurity(BCVA) [ Time Frame: 2020-12 ]
    Compare the changes of BCVA before treatment, 1 week after treatment and 1 month after treatment

  3. low optical ratio(LOR) [ Time Frame: 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


Secondary Outcome Measures :
  1. Ellipsoid Zone [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with diabetic macular edema in the Renmin Hospital of Wuhan University during the study period
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

Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04254536


Contacts
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Contact: Hongmei Zheng, MD +86 13871484442 13871484442@139.com
Contact: Jingwen Jiang +86 15623512305 568314041@qq.com

Sponsors and Collaborators
Renmin Hospital of Wuhan University
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Renmin Hospital of Wuhan University
ClinicalTrials.gov Identifier: NCT04254536    
Other Study ID Numbers: OCT-LOR-DME
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Renmin Hospital of Wuhan University:
diebetic macular edema
optical coherence tomography
conbercept
Additional relevant MeSH terms:
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Macular Edema
Edema
Macular Degeneration
 Retinal Degeneration
Retinal Diseases
Eye Diseases