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

NCT ID: NCT04627402

Last Updated: 2020-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-12

Study Completion Date

2021-12-31

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.

Conditions

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Diabetes Mellitus, Type 2 Macular Edema

Keywords

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diabetic macular edema; conbercept; triamcinolone acetonide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Diabetic macular edema.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Injection combo agents

Intravitreous injection of triamcinolone acetonide (TA) and conbercept.

Group Type EXPERIMENTAL

Conbercept and TA

Intervention Type DRUG

Intravitreous injection of Conbercept and TA

Injection single agent

Intravitreous injection of conbercept only.

Group Type ACTIVE_COMPARATOR

Conbercept

Intervention Type DRUG

Intravitreous injection of Conbercept

Interventions

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Conbercept and TA

Intravitreous injection of Conbercept and TA

Intervention Type DRUG

Conbercept

Intravitreous injection of Conbercept

Intervention Type DRUG

Other Intervention Names

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Combined agents Single agent

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Bingqian Liu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bingqian Liu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthamic Center, Sun Yat-sen University

Locations

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Zhongshan Opthalmic Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qiuyi Liang, BS

Role: CONTACT

Phone: +86 20 66683995

Email: [email protected]

Facility Contacts

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Qiuyi Liang, BS

Role: primary

References

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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.

Reference Type RESULT
PMID: 29127949 (View on PubMed)

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.

Reference Type RESULT
PMID: 28902334 (View on PubMed)

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.

Reference Type RESULT
PMID: 23706949 (View on PubMed)

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.

Reference Type RESULT
PMID: 29104958 (View on PubMed)

Other Identifiers

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2020KYPJ127

Identifier Type: -

Identifier Source: org_study_id