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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Adding Triamcinolone Acetonide to Conbercept in Diabetic Macular Edema With Limited Response to Anti-VEGF Treatment After One Injection

Conditions
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Diabetes Mellitus, Type 2, Macular Edema

Intervention / Treatment
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* Drug: Conbercept and TA
* Drug: Conbercept


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Diabetic macular edema.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Injection combo agents<br>Intravitreous injection of triamcinolone acetonide (TA) and conbercept. | Drug: Conbercept and TA<br>* Intravitreous injection of Conbercept and TA<br>* Other names: Combined agents;|
| Active Comparator: Injection single agent<br>Intravitreous injection of conbercept only. | Drug: Conbercept<br>* Intravitreous injection of Conbercept<br>* Other names: Single agent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macular thickness | Change in mean central subfield thickness from randomization visit measured with optical coherence tomography. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best-corrected visual acuity (BCVA) | Change in BCVA letter score from randomization visit as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS). | 48 weeks | 
| Treatment number | The number of intravitreous injection treatments | 48 weeks | 
| Incidence of complications | The incidence of cataract and glaucoma | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic macular edema; conbercept; triamcinolone acetonide