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

Not Applicable

• Conditions: Diabetes Mellitus, Type 2; Macular Edema
• Interventions: Drug: Conbercept and TA; Drug: Conbercept

• Registration Number: NCT04627402
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

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.

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 Timeline

• Study First Submitted: 2020-10-29
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-10
• Study Start: 2020-11-12
• Study First Posted: 2020-11-13
• Last Update Submitted: 2020-11-14
• Last Update Posted: 2020-11-17
• Primary Completion: 2021-06-01
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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%.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Injection combo agents	Conbercept and TA	Intravitreous injection of triamcinolone acetonide (TA) and conbercept.
Injection single agent	Conbercept	Intravitreous injection of conbercept only.

Primary Outcome Measures

Name	Time	Method
Macular thickness	24 weeks	Change in mean central subfield thickness from randomization visit measured with optical coherence tomography.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zhongshan Opthalmic Center; 🇨🇳 Guangzhou, Guangdong, China