Phacoemulsification Combined With Intravitreal Injection of Ranibizumab Prevent Postoperative Capillary Non-perfusion Zone Progress in Non-proliferative Diabetic Retinopathy
Primary Purpose
Mild Non-proliferative Diabetic Retinopathy, Cataract Diabetic, Diabetic Retinopathy
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Ranibizumab Injection [Lucentis]
Phacoemulsification
Sponsored by
About this trial
This is an interventional treatment trial for Mild Non-proliferative Diabetic Retinopathy focused on measuring Phaco, VEGF, diabetic retinopathy
Eligibility Criteria
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
Sites / Locations
- Department of Ophthalmology, Ruijin Hospital Affiliated Medical,Shanghai Jiaotong University SchoolRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Cataract phacoemulsification combines Ranibizumab
Cataract phacoemulsification
Arm Description
0.05 ml of ranibizumab was injected into the vitreous immediately after the operation
0.05 ml of ranibizumab was injected into the vitreous immediately after the operation
Outcomes
Primary Outcome Measures
capillary non-perfusion zone of non-proliferative diabetic retinopathy
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.
Secondary Outcome Measures
Determination of inflammatory factors in anterior aqueous humor
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05386160
Brief Title
Phacoemulsification Combined With Intravitreal Injection of Ranibizumab Prevent Postoperative Capillary Non-perfusion Zone Progress in Non-proliferative Diabetic Retinopathy
Official Title
Department of Ophthalmology, Ruijin Hospital, Affiliated Medical School, Shanghai Jiaotong University
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ruijin Hospital
4. Oversight
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
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Non-proliferative Diabetic Retinopathy, Cataract Diabetic, Diabetic Retinopathy
Keywords
Phaco, VEGF, diabetic retinopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model 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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cataract phacoemulsification combines Ranibizumab
Arm Type
Active Comparator
Arm Description
0.05 ml of ranibizumab was injected into the vitreous immediately after the operation
Arm Title
Cataract phacoemulsification
Arm Type
Active Comparator
Arm Description
0.05 ml of ranibizumab was injected into the vitreous immediately after the operation
Intervention Type
Drug
Intervention Name(s)
Ranibizumab Injection [Lucentis]
Other Intervention Name(s)
Phacoemulsification
Intervention Description
intravitreal injection of Ranibizumab;
Intervention Type
Device
Intervention Name(s)
Phacoemulsification
Intervention Description
Phacoemulsification
Primary Outcome Measure Information:
Title
capillary non-perfusion zone of non-proliferative diabetic retinopathy
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Determination of inflammatory factors in anterior aqueous humor
Description
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.
Time Frame
before cataract phacoemulsification
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zijian Yang, Dr.
Phone
+862167888999
Ext
88024
Email
dyangzj@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zijian Yang, Dr
Organizational Affiliation
Department of Ophthalmology, Ruijin Hospital north, Affiliated Medical School, Shanghai Jiaotong University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Ophthalmology, Ruijin Hospital Affiliated Medical,Shanghai Jiaotong University School
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zijian Yang, Dr.
Phone
18121261251
Email
dyangzj@163.com
First Name & Middle Initial & Last Name & Degree
Huiping Yao, Dr.
12. IPD Sharing Statement
Learn more about this trial
Phacoemulsification Combined With Intravitreal Injection of Ranibizumab Prevent Postoperative Capillary Non-perfusion Zone Progress in Non-proliferative Diabetic Retinopathy
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