Prophylactic Effect of Conbercept Intravitreal Injection at the Conclusion of Cataract Surgery for Diabetic Macular Edema

December 9, 2020 updated by: Eye & ENT Hospital of Fudan University

Prophylactic Effect of Conbercept Intravitreal Injection at the Conclusion of Cataract Surgery for Diabetic Macular Edema in Cataract Patients With Diabetic Retinopathy

Diabetic macular edema (DME) is an important cause of central vision impairment among people with diabetic retinopathy (DR), which can have a significant adverse effect on daily activities and quality of life. Diabetic patients with preexisting DME are at increased risk of worsening edema following cataract surgery. Previous studies also reported progression of DR after cataract surgery. Clinically significant DME is now classified into center-involved DME (CI-DME) and non center-involved DME (non-CI DME). Randomized clinical trials have established intravitreal antivascular endothelial growth factor (VEGF) therapy as first-line treatment for visual impairment from CI-DME and studies have addressed the influence of anti-VEGF therapy among patients with DME undergoing cataract surgery. However, for patients with non-CI DME before cataract surgery, whether anti-VEGF therapy is necessary at the end of surgery to prevent CI-DME is still clinically controversial. In order to evaluate the prophylactic effect of Conbercept (a recombinant fusion protein with high affinity to all VEGF isoforms and PIGF) intravitreal injection at the conclusion of cataract surgery for DME in patients with DR, the investigators will prospectively recruit 40 cataract patients with DR and non-CI DME and randomly assign these subjects into the study group (combined cataract surgery and intravitreal Conbercept injection, 20 cases) and the control group (cataract surgery alone, 20 cases). The primary outcomes include mean changes in central retinal thickness (CRT) and in diabetic retinopathy severity score (DRSS). The secondary outcomes include changes in best corrected visual acuity (BCVA), foveal avascular zone (FAZ), retinal vessel density (VD), the aqueous concentrations of VEGF, PIGF, interleukin- (IL-) 2, IL-5, IL-6, and IL-8.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

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 Contact

Study Contact Backup

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:

  • Patients sign informed consent, and are willing and able to comply with all the follow-ups
  • Age ≥ 18 years , both genders
  • Diagnosis of type 1 or type 2 diabetes mellitus
  • Serum HbA1c ≤ 10%
  • Patients with a diagnosis of DR (ETDRS 35-53) and cataract

Exclusion Criteria:

  • CI-DME
  • Any other ocular disorder in the study eye that may cause macular edema excluded the diabetic retinopathy
  • History of allergic reaction to fluorescein, protein agents for diagnosis or therapy, or more than 2 drug or nondrug factors, or concomitant allergic diseases
  • Received anti- VEGF treatment (including intravitreal injection or systematic application) within three months prior to enrollment
  • History of panretinal laser photocoagulation (PRP) in the study eye 6 months prior to enrollment, or possibly need panretinal photocoagulation of the study eye during the study
  • Intraocular conventional surgery within the past three months
  • Traumatic cataract or congenital bilateral cataract in the study eye
  • Active ocular or periocular infection in either eye
  • Iris neovascularization in the study eye
  • Uncontrolled glaucoma, or history of glaucoma surgery
  • Aphakia in the study eye
  • History of vitrectomy in the study eye
  • The density of corneal endothelial cells is lower than 2000/mm2
  • 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
  • Any surgical contraindications
  • Uncontrolled Blood Pressure
  • Myocardial infarction, heart failure, stroke, or transient ischemic attack within one month
  • Renal Failure
  • Pregnant or breast-feeding women
  • Participation in another simultaneous medical investigator or trial
  • Other situations where the researcher judges that the patient is not suitable for inclusion

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: combined cataract surgery and intravitreal Conbercept injection
Subjects will receive conbercept injections at a dose of 0.5 mg/eye at the conclusion of cataract surgery.
Procedure: Conbercept intravitreal injection
intravitreal injection of 0.5 mg conbercept at the conclusion of cataract surgery
NO_INTERVENTION: cataract surgery alone
Subjects will undergo cataract surgery by phacoemulsification and intraocular lens implantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in central retinal thickness (CRT) with optical coherence tomography (OCT)
Time Frame: Baseline, 1 month and 3 month after operation
to compare the mean change from baseline of CRT between treatment group and control group at month 1 and 3
Baseline, 1 month and 3 month after operation
change in diabetic retinopathy severity score (DRSS)
Time Frame: Baseline, 1 month and 3 month after operation
to compare the mean change from baseline of DRSS between treatment group and control group at month 1 and 3
Baseline, 1 month and 3 month after operation

Secondary Outcome Measures

Outcome Measure
Time Frame
change in best corrected visual acuity (BCVA)
Time Frame: Baseline, 1 month and 3 month after operation
Baseline, 1 month and 3 month after operation
change in foveal avascular zone (FAZ) with optical coherence tomography angiography (OCTA)
Time Frame: Baseline, 1 month and 3 month after operation
Baseline, 1 month and 3 month after operation
change in retinal vessel density (VD) with optical coherence tomography angiography (OCTA)
Time Frame: Baseline, 1 month and 3 month after operation
Baseline, 1 month and 3 month after operation
change in the aqueous concentrations of VEGF, PIGF, interleukin- (IL-) 2, IL-5, IL-6, and IL-8
Time Frame: Baseline, 1 week, 1 month and 3 month after operation
Baseline, 1 week, 1 month and 3 month after operation

Collaborators and Investigators

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

Sponsor

Eye & ENT Hospital of Fudan University

Investigators

  • Study Chair: Jin Yang, MD, ph.D., Eye & ENT Hospital of Fudan 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 (ANTICIPATED)

January 1, 2021

Primary Completion (ANTICIPATED)

November 1, 2021

Study Completion (ANTICIPATED)

January 1, 2022

Study Registration Dates

First Submitted

December 9, 2020

First Submitted That Met QC Criteria

December 9, 2020

First Posted (ACTUAL)

December 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 16, 2020

Last Update Submitted That Met QC Criteria

December 9, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Yumeng Shi

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.

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