Clincosm LogoSign in Get a demo

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

Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04627402
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
13.6
Anticipated Duration (Months)
3.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Diabetic macular edema.Diabetic macular edema.
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Adding Triamcinolone Acetonide to Conbercept in Diabetic Macular Edema With Limited Response to Anti-VEGF Treatment After One Injection
Actual Study Start Date :
Nov 12, 2020
Anticipated Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Macular thickness [24 weeks]

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

    Secondary Outcome Measures

    1. Best-corrected visual acuity (BCVA) [48 weeks]

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

    2. Treatment number [48 weeks]

      The number of intravitreous injection treatments

    3. Incidence of complications [48 weeks]

      The incidence of cataract and glaucoma

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhongshan Opthalmic Center Guangzhou Guangdong China 510060

    Sponsors and Collaborators

    • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bingqian Liu, Associate Professor, Zhongshan Ophthalmic Center, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT04627402
    Other Study ID Numbers:
    • 2020KYPJ127
    First Posted:
    Nov 13, 2020
    Last Update Posted:
    Nov 17, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bingqian Liu, Associate Professor, Zhongshan Ophthalmic Center, Sun Yat-sen University
    diabetic macular edema; conbercept; triamcinolone acetonide
    Additional relevant MeSH terms:
    Macular Edema
    Diabetes Mellitus, Type 2
    Edema

    Study Results

    No Results Posted as of Nov 17, 2020