Clinical trial NCT05386160: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Mild Non-proliferative Diabetic Retinopathy
Cataract Diabetic
Diabetic Retinopathy
Keywords: Phaco
VEGF
diabetic retinopathy
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: capillary non-perfusion zone of non-proliferative diabetic retinopathy
timeFrame: 1 year
Secondary outcomes:
measure: Determination of inflammatory factors in anterior aqueous humor
timeFrame: before cataract phacoemulsification
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Ophthalmology, Ruijin Hospital Affiliated Medical,Shanghai Jiaotong University School
state: Shanghai
Study officials:
affiliation: Department of Ophthalmology, Ruijin Hospital north, Affiliated Medical School, Shanghai Jiaotong University
name: Zijian Yang, Dr
role: STUDY_DIRECTOR
References: