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

November 14, 2020 updated by: Bingqian Liu, Zhongshan Ophthalmic Center, Sun Yat-sen University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Zhongshan Opthalmic Center
        • Contact:
        • Principal Investigator:
          • Bingqian Liu, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Injection combo agents
Intravitreous injection of triamcinolone acetonide (TA) and conbercept.
Drug: Conbercept and TA
Intravitreous injection of Conbercept and TA
Other Names:
  • Combined agents
Active Comparator: Injection single agent
Intravitreous injection of conbercept only.
Drug: Conbercept
Intravitreous injection of Conbercept
Other Names:
  • Single agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Macular thickness
Time Frame: 24 weeks
Change in mean central subfield thickness from randomization visit measured with optical coherence tomography.
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best-corrected visual acuity (BCVA)
Time Frame: 48 weeks
Change in BCVA letter score from randomization visit as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS).
48 weeks
Treatment number
Time Frame: 48 weeks
The number of intravitreous injection treatments
48 weeks
Incidence of complications
Time Frame: 48 weeks
The incidence of cataract and glaucoma
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Investigators

  • Principal Investigator: Bingqian Liu, MD, PhD, Zhongshan Ophthamic Center, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2020

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

October 29, 2020

First Submitted That Met QC Criteria

November 10, 2020

First Posted (Actual)

November 13, 2020

Study Record Updates

Last Update Posted (Actual)

November 17, 2020

Last Update Submitted That Met QC Criteria

November 14, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020KYPJ127

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Conbercept and TA

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe