Clinical trial NCT04627402: Effects of Adding Triamcinolone Acetonide to Conbercept Treatment for Refractory Diabetic Macular Edema (CONTE)
Official title: Effects of Adding Triamcinolone Acetonide to Conbercept in Diabetic Macular Edema With Limited Response to Anti-VEGF Treatment After One Injection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Macular Edema
Keywords: diabetic macular edema; conbercept; triamcinolone acetonide
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Diabetic macular edema.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Macular thickness
timeFrame: 24 weeks
Secondary outcomes:
measure: Best-corrected visual acuity (BCVA)
timeFrame: 48 weeks
measure: Treatment number
timeFrame: 48 weeks
measure: Incidence of complications
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Opthalmic Center
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthamic Center, Sun Yat-sen University
name: Bingqian Liu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maturi RK, Glassman AR, Liu D, Beck RW, Bhavsar AR, Bressler NM, Jampol LM, Melia M, Punjabi OS, Salehi-Had H, Sun JK; Diabetic Retinopathy Clinical Research Network. Effect of Adding Dexamethasone to Continued Ranibizumab Treatment in Patients With Persistent Diabetic Macular Edema: A DRCR Network Phase 2 Randomized Clinical Trial. JAMA Ophthalmol. 2018 Jan 1;136(1):29-38. doi: 10.1001/jamaophthalmol.2017.4914.
citation: Neto HO, Regatieri CV, Nobrega MJ, Muccioli C, Casella AM, Andrade RE, Maia M, Kniggendorf V, Ferreira M, Branco AC, Belfort R Jr. Multicenter, Randomized Clinical Trial to Assess the Effectiveness of Intravitreal Injections of Bevacizumab, Triamcinolone, or Their Combination in the Treatment of Diabetic Macular Edema. Ophthalmic Surg Lasers Imaging Retina. 2017 Sep 1;48(9):734-740. doi: 10.3928/23258160-20170829-08.
citation: Brown DM, Nguyen QD, Marcus DM, Boyer DS, Patel S, Feiner L, Schlottmann PG, Rundle AC, Zhang J, Rubio RG, Adamis AP, Ehrlich JS, Hopkins JJ; RIDE and RISE Research Group. Long-term outcomes of ranibizumab therapy for diabetic macular edema: the 36-month results from two phase III trials: RISE and RIDE. Ophthalmology. 2013 Oct;120(10):2013-22. doi: 10.1016/j.ophtha.2013.02.034. Epub 2013 May 22.
citation: Shah AR, Yonekawa Y, Todorich B, Van Laere L, Hussain R, Woodward MA, Abbey AM, Wolfe JD. Prediction of Anti-VEGF Response in Diabetic Macular Edema After 1 Injection. J Vitreoretin Dis. 2017 May;1(3):169-174. doi: 10.1177/2474126416682569. Epub 2017 Feb 1.