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

Diabetes Mellitus, Type 2 Clinical Trial

— CONTE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04627402
• Other study ID #: 2020KYPJ127
• Status: Recruiting
• Phase: N/A
• Start date: November 12, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2020
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: Qiuyi Liang, BS
• Phone: +86 20 66683995
• Email: liubq6[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Edema
• Macular Edema

Intervention

Drug:
• Conbercept and TA
Intravitreous injection of Conbercept and TA
• Conbercept
Intravitreous injection of Conbercept

Locations

Country	Name	City	State
China	Zhongshan Opthalmic Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (4)

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 — View 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 Persi — View 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, — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Macular thickness	Change in mean central subfield thickness from randomization visit measured with optical coherence tomography.	24 weeks
Secondary	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
Secondary	Treatment number	The number of intravitreous injection treatments	48 weeks
Secondary	Incidence of complications	The incidence of cataract and glaucoma	48 weeks