Effects of Adding Triamcinolone Acetonide to Conbercept Treatment for Refractory Diabetic Macular Edema (CONTE)
CONTE
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus-type-2
Started Nov 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2020
CompletedStudy Start
First participant enrolled
November 12, 2020
CompletedFirst Posted
Study publicly available on registry
November 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedNovember 17, 2020
November 1, 2020
7 months
October 29, 2020
November 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Macular thickness
Change in mean central subfield thickness from randomization visit measured with optical coherence tomography.
24 weeks
Secondary Outcomes (3)
Best-corrected visual acuity (BCVA)
48 weeks
Treatment number
48 weeks
Incidence of complications
48 weeks
Study Arms (2)
Injection combo agents
EXPERIMENTALIntravitreous injection of triamcinolone acetonide (TA) and conbercept.
Injection single agent
ACTIVE COMPARATORIntravitreous injection of conbercept only.
Interventions
Intravitreous injection of Conbercept and TA
Intravitreous injection of Conbercept
Eligibility Criteria
You may qualify if:
- 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%.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhongshan Opthalmic Center
Guangzhou, Guangdong, 510060, China
Related Publications (4)
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.
PMID: 29127949RESULTNeto 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.
PMID: 28902334RESULTBrown 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.
PMID: 23706949RESULTShah 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.
PMID: 29104958RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bingqian Liu, MD, PhD
Zhongshan Ophthamic Center, Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 29, 2020
First Posted
November 13, 2020
Study Start
November 12, 2020
Primary Completion
June 1, 2021
Study Completion
December 31, 2021
Last Updated
November 17, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share