Phacoemulsification Combined With Intravitreal Injection of Ranibizumab Prevent Postoperative Capillary Non-perfusion Zone Progress in Non-proliferative Diabetic Retinopathy

May 18, 2022 updated by: Ruijin Hospital

Department of Ophthalmology, Ruijin Hospital, Affiliated Medical School, Shanghai Jiaotong University

Diabetic retinopathy has been found progress in 20-70% diabetic patient after cataract phacoemulsification surgery. Intravitreal injection of anti-VEGF Ranibizumab is an important treatment for diabetic retinopathy including non-proliferative diabetic retinopathy (NPDR). However, there is no research about phacoemulsification surgery combine Intravitreal injection of Ranibizumab on diabetic retinopathy. The research focus on the effect of phacoemulsification surgery combine intravitreal injection of Ranibizumab on mild non-proliferative diabetic retinopathy and explore the reasons for differences in treatment outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This research is a single-center prospective, randomized controlled study. Patient were divided into two groups, the control group is phacoemulsification surgery group and the intervention group is phacoemulsification surgery combine intravitreal injection of Ranibizumab group. Eye examination including visual acuity, intraocular pressure(IOP), fundus fluoroscopy, macular optical coherence tomograph（OCT） examination, were taken before cataract surgery. The anterior aqueous humor was extracted before cataract phacoemulsification in the combined operation group, and 0.05 ml of ranibizumab was injected into the vitreous immediately after the operation. The aqueous humor concentrations of vascular endothelial growth factor（VEGF）, interleukin（IL）IL-2, IL-4, and Tumor Necrosis Factor（TNF） were checked by real-time polymerase chain reaction assay（RT-PCR） and ELISA analysis. The Best Corrected Visual Acuity（BCVA）, IOP and fundus lesions changes were observed in the two groups after operation. Diabetic retinopathy capillary non-perfusion zone were evaluated one year after phacoemulsification surgery.

Study Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Phase 4

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

  • Name: Zijian Yang, Dr.
  • Phone Number: 88024 +862167888999
  • Email: dyangzj@163.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Department of Ophthalmology, Ruijin Hospital Affiliated Medical,Shanghai Jiaotong University School
        • Contact:
        • Contact:
          • Huiping Yao, Dr.

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 to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed and dated informed consent
  • Commitment to follow the research procedures and cooperate with the implementation of the whole process of research
  • No specific gender, 18+ years old
  • Diagnosed in line with NPDR,
  • Phacoemulsification combined with anti-VEGF therapy is planned
  • No obvious surgical contraindications

Exclusion Criteria:

  • Use of other investigational drug treatments or take part in other types of clinical studies
  • Allergy to anti-VEGF drugs
  • Patients with other macular and optic disc diseases
  • Patients with meaningful diabetic macular edema
  • Patient with surgical complications

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cataract phacoemulsification combines Ranibizumab
0.05 ml of ranibizumab was injected into the vitreous immediately after the operation
Drug: Ranibizumab Injection [Lucentis]
intravitreal injection of Ranibizumab；
Other Names:
  • Phacoemulsification
Active Comparator: Cataract phacoemulsification
0.05 ml of ranibizumab was injected into the vitreous immediately after the operation
Drug: Ranibizumab Injection [Lucentis]
intravitreal injection of Ranibizumab；
Other Names:
  • Phacoemulsification
Device: Phacoemulsification
Phacoemulsification

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
capillary non-perfusion zone of non-proliferative diabetic retinopathy
Time Frame: 1 year
Patient were divided into two groups, the control group is phacoemulsification surgery group and the intervention group is phacoemulsification surgery combine intravitreal injection of Ranibizumab group. Eye examination including visual acuity, intraocular pressure (IOP), fundus fluoroscopy, macular OCT examination, were taken before cataract surgery. The anterior aqueous humor was extracted before cataract phacoemulsification in the combined operation group, and 0.05 ml of ranibizumab was injected into the vitreous immediately after the operation. The BCVA, IOP and fundus lesions changes were observed in the two groups after operation. Diabetic retinopathy capillary non-perfusion zone were evaluated one year after phacoemulsification surgery.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of inflammatory factors in anterior aqueous humor
Time Frame: before cataract phacoemulsification
The anterior aqueous humor was extracted before cataract phacoemulsification in the combined operation group. The aqueous humor concentrations of VEGF, IL-2, IL-4, and TNF were checked by RT-PCR and ELISA analysis.
before cataract phacoemulsification

Collaborators and Investigators

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

Sponsor

Ruijin Hospital

Investigators

  • Study Director: Zijian Yang, Dr, Department of Ophthalmology, Ruijin Hospital north, Affiliated Medical School, Shanghai Jiaotong University

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)

July 1, 2022

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

April 26, 2022

First Submitted That Met QC Criteria

May 18, 2022

First Posted (Actual)

May 23, 2022

Study Record Updates

Last Update Posted (Actual)

May 23, 2022

Last Update Submitted That Met QC Criteria

May 18, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RuijinH202201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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