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

Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05386160
• Other study ID #: RuijinH202201
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: January 2022
• Source: Ruijin Hospital
• Contact: Zijian Yang, Dr.
• Phone: +862167888999
• Email: dyangzj[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Cataract Diabetic
• Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• Ranibizumab Injection [Lucentis]
intravitreal injection of Ranibizumab;

Device:
• Phacoemulsification
Phacoemulsification

Locations

Country	Name	City	State
China	Department of Ophthalmology, Ruijin Hospital Affiliated Medical,Shanghai Jiaotong University School	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Secondary	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.	before cataract phacoemulsification