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

Primary Purpose

Diabetes Mellitus, Type 2, Macular Edema

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Conbercept and TA
Conbercept
Sponsored by
Zhongshan Ophthalmic Center, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring diabetic macular edema; conbercept; triamcinolone acetonide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhongshan Opthalmic CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Injection combo agents

Injection single agent

Arm Description

Intravitreous injection of triamcinolone acetonide (TA) and conbercept.

Intravitreous injection of conbercept only.

Outcomes

Primary Outcome Measures

Macular thickness
Change in mean central subfield thickness from randomization visit measured with optical coherence tomography.

Secondary Outcome Measures

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

Full Information

First Posted
October 29, 2020
Last Updated
November 14, 2020
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04627402
Brief Title
Effects of Adding Triamcinolone Acetonide to Conbercept Treatment for Refractory Diabetic Macular Edema (CONTE)
Acronym
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 12, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Macular Edema
Keywords
diabetic macular edema; conbercept; triamcinolone acetonide

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Diabetic macular edema.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Injection combo agents
Arm Type
Experimental
Arm Description
Intravitreous injection of triamcinolone acetonide (TA) and conbercept.
Arm Title
Injection single agent
Arm Type
Active Comparator
Arm Description
Intravitreous injection of conbercept only.
Intervention Type
Drug
Intervention Name(s)
Conbercept and TA
Other Intervention Name(s)
Combined agents
Intervention Description
Intravitreous injection of Conbercept and TA
Intervention Type
Drug
Intervention Name(s)
Conbercept
Other Intervention Name(s)
Single agent
Intervention Description
Intravitreous injection of Conbercept
Primary Outcome Measure Information:
Title
Macular thickness
Description
Change in mean central subfield thickness from randomization visit measured with optical coherence tomography.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Best-corrected visual acuity (BCVA)
Description
Change in BCVA letter score from randomization visit as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS).
Time Frame
48 weeks
Title
Treatment number
Description
The number of intravitreous injection treatments
Time Frame
48 weeks
Title
Incidence of complications
Description
The incidence of cataract and glaucoma
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiuyi Liang, BS
Phone
+86 20 66683995
Email
liubq6@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bingqian Liu, MD, PhD
Organizational Affiliation
Zhongshan Ophthamic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Opthalmic Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiuyi Liang, BS
Phone
+86 20 66683995
Email
liubq6@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Bingqian Liu, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29127949
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.
Results Reference
result
PubMed Identifier
28902334
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.
Results Reference
result
PubMed Identifier
23706949
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.
Results Reference
result
PubMed Identifier
29104958
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.
Results Reference
result

Learn more about this trial

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

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