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

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 4

Conditions: Mild Non-proliferative Diabetic Retinopathy; Cataract Diabetic; Diabetic Retinopathy

Treatments: Drug: Ranibizumab Injection [Lucentis]; Device: Phacoemulsification

Study type: Interventional

Funder types: Other

Identifiers

NCT05386160

RuijinH202201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

96 participants in 2 patient groups

Cataract phacoemulsification combines Ranibizumab

Active Comparator group

Description:

0.05 ml of ranibizumab was injected into the vitreous immediately after the operation

Treatment:

Drug: Ranibizumab Injection [Lucentis]

Cataract phacoemulsification

Active Comparator group

Description:

0.05 ml of ranibizumab was injected into the vitreous immediately after the operation

Treatment:

Device: Phacoemulsification

Drug: Ranibizumab Injection [Lucentis]