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Effects of Adding Triamcinolone Acetonide to Conbercept Treatment for Refractory Diabetic Macular Edema (CONTE) (CONTE)

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ClinicalTrials.gov Identifier: NCT04627402
Recruitment Status : Recruiting
First Posted : November 13, 2020
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Bingqian Liu, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study Description
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Brief Summary:
This study aimed to compare intravitreous conbercept alone with conbercept plus intravitreous triamcinolone acetonide in DME eyes which showed limited response to anti-VEGF treatment after one injection.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Macular Edema Drug: Conbercept and TA Drug: Conbercept Not Applicable

Detailed Description:
Some eyes with diabetic macular edema (DME) were not sensitive to anti-vascular endothelial growth factor (anti-VEGF) therapy and required continuous injections. Delayed control of macular edema might cause irreversible function loss. To predict the response to anti-VEGF treatment according to the CST change after one injection was proved reasonable recently. Adding intravitreous corticosteroids to the treatment regimen at early time might result in better outcomes than anti-VEGF therapy alone. Patients with diagnosis of refractory diabetic macular edema, confirmed by fluorangiography and optical coherence tomography (OCT), with limited response to one intravitreal anti-VEGF injection will be enrolled in the study. The enrolled patients will be randomized for the addition or not of the triamcinolone to intravitreal therapy.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Diabetic macular edema.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Adding Triamcinolone Acetonide to Conbercept in Diabetic Macular Edema With Limited Response to Anti-VEGF Treatment After One Injection
Actual Study Start Date : November 12, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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Arm Intervention/treatment
Experimental: Injection combo agents
Intravitreous injection of triamcinolone acetonide (TA) and conbercept.
 Drug: Conbercept and TA
Intravitreous injection of Conbercept and TA
Other Name: Combined agents
Active Comparator: Injection single agent
Intravitreous injection of conbercept only.
 Drug: Conbercept
Intravitreous injection of Conbercept
Other Name: Single agent


Outcome Measures
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Primary Outcome Measures :
  1. Macular thickness [ Time Frame: 24 weeks ]
    Change in mean central subfield thickness from randomization visit measured with optical coherence tomography.


Secondary Outcome Measures :
  1. Best-corrected visual acuity (BCVA) [ Time Frame: 48 weeks ]
    Change in BCVA letter score from randomization visit as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS).

  2. Treatment number [ Time Frame: 48 weeks ]
    The number of intravitreous injection treatments

  3. Incidence of complications [ Time Frame: 48 weeks ]
    The incidence of cataract and glaucoma


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type II diabetes
  • Vison decrease was mainly caused by diabetic macular edema (DME)
  • BCVA of 20/800 to 20/40 (decimal)
  • Central subfield retinal thickness (CST) ≥ 300μm by optical coherence tomography (OCT) in the study eye
  • Pan-retinal photocoagulation finished at least 3 months ago, or no pan-retinal photocoagulation is expected in the next 6 months
  • Within the last 3 months, one intravitreous injection of anti-VEGF agent was performed, the CST reduction one month after injection was ≤ 20%.

Exclusion Criteria:

  • Non-DME related macular edema, or edema control would not benefit the vision (for example, macular atrophy)
  • Exist of other reasons of macular edema, retinal vein occlusion, uveitis, iris rubeosis, high myopia
  • Ocular media opacity of insufficient quality to obtain OCT images and fundus images in the study eye
  • Intraocular or periorbital injection of steroids within the last 3 months
  • Macular grid photocoagulation within the last 4 months
  • History of vitrectomy
  • History of scleral buckle within the last 4 months, or intraocular surgery is expected in the next 6 months
  • Any sign of ocular infection, including conjunctivitis, hordeolum, dacryocystitis
  • Myocardial infarction, heart failure, stroke, or transient ischemic attack within one month
  • Pregnant or breastfeeding women
  • Uncontrolled hypertension, or blood pressure >180/110
  • Patients with uncontrolled hyperglycemia, or Hemoglobin A1C (HbA1c) ≥10.0%, or under hemodialysis , or started insulin usage within the last 4 months, or expected to start insulin use for hyperglycemia control in the next 4 months
  • Those cannot follow visits on time
Contacts and Locations
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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): NCT04627402


Contacts
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Contact: Qiuyi Liang, BS +86 20 66683995 liubq6@mail.sysu.edu.cn

Locations
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China, Guangdong
Zhongshan Opthalmic Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Qiuyi Liang, BS    +86 20 66683995    liubq6@mail.sysu.edu.cn   
Principal Investigator: Bingqian Liu, MD, PhD         
Sponsors and Collaborators
Zhongshan Ophthalmic Center, Sun Yat-sen University
Investigators
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Principal Investigator: Bingqian Liu, MD, PhD Zhongshan Ophthamic Center, Sun Yat-sen University
More Information
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Publications of Results:

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Responsible Party: Bingqian Liu, Associate Professor, Zhongshan Ophthalmic Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04627402    
Other Study ID Numbers: 2020KYPJ127
First Posted: November 13, 2020    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Bingqian Liu, Zhongshan Ophthalmic Center, Sun Yat-sen University:
diabetic macular edema; conbercept; triamcinolone acetonide
Additional relevant MeSH terms:
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Macular Edema
Diabetes Mellitus, Type 2
Edema
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases