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Diabetes Mellitus, Type 2CONTENCT04627402

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

A study testing Conbercept and TA and Conbercept in people with Diabetes Mellitus, Type 2 and Macular Edema, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2, Macular Edema
What is being tested?
Conbercept and TA and Conbercept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
12 Nov 2020to 31 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%.

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Qiuyi Liang, BS contact

+86 20 66683995

liubq6@mail.sysu.edu.cn

China1 site, 1 recruiting

  • Zhongshan Opthalmic Center

    Guangzhou, Guangdong, 510060

    Qiuyi Liang, BS, +86 20 66683995, liubq6@mail.sysu.edu.cn

    Bingqian Liu, MD, PhD

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Conbercept and TA, Conbercept
Keywords
diabetic macular edema; conbercept; triamcinolone acetonide
Medical subject headings
Diabetes Mellitus, Type 2, Macular Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conbercept and TADrug

    Also called Combined agents

    Intravitreous injection of Conbercept and TA

  • ConberceptDrug

    Also called Single agent

    Intravitreous injection of Conbercept

Study groups in NCT04627402
Study groupRoleWhat they receive
Injection combo agentsExperimentalIntravitreous injection of triamcinolone acetonide (TA) and conbercept.
Receives: Drug: Conbercept and TA
Injection single agentActive comparatorIntravitreous injection of conbercept only.
Receives: Drug: Conbercept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Macular thickness

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

    Measured: 24 weeks

Secondary outcomes (3)

  1. Best-corrected visual acuity (BCVA)

    Change in BCVA letter score from randomization visit as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS).

    Measured: 48 weeks

  2. Treatment number

    The number of intravitreous injection treatments

    Measured: 48 weeks

  3. Incidence of complications

    The incidence of cataract and glaucoma

    Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2020
  2. Study start12 Nov 2020
  3. Primary completion1 Jun 2021 (estimated)
  4. Study completion31 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Diabetic macular edema.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04627402
Sponsor's protocol ID
2020KYPJ127
Acronym
CONTE
Status last verified
Nov 2020
First submitted
29 Oct 2020
Last updated
17 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29127949

  • 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.

    PubMed 28902334

  • 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.

    PubMed 23706949

  • 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.

    PubMed 29104958

Questions about this trial

What is this clinical trial studying?

A study testing Conbercept and TA and Conbercept in people with Diabetes Mellitus, Type 2 and Macular Edema, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Qiuyi Liang, BS (+86 20 66683995, liubq6@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Macular thickness (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04627402, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.

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