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

NCT05386160 | Unknown Phase 4 FDA Drug FDA Device

• 1 other identifier: RuijinH202201
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Phaco; VEGF; diabetic retinopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Determination of inflammatory factors in anterior aqueous humor

  before cataract phacoemulsification

Study Arms (2)

Cataract phacoemulsification combines Ranibizumab

ACTIVE COMPARATOR

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

Drug: Ranibizumab Injection [Lucentis]

Cataract phacoemulsification

ACTIVE COMPARATOR

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

Drug: Ranibizumab Injection [Lucentis]; Device: Phacoemulsification

Interventions

Ranibizumab Injection [Lucentis] DRUG

intravitreal injection of Ranibizumab；

Also known as: Phacoemulsification

Cataract phacoemulsification; Cataract phacoemulsification combines Ranibizumab

Phacoemulsification DEVICE

Phacoemulsification

Cataract phacoemulsification

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Ranibizumab; Phacoemulsification

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Cataract Extraction; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Officials

• Zijian Yang, Dr

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

  STUDY DIRECTOR

Central Study Contacts

Zijian Yang, Dr.

CONTACT

+862167888999; dyangzj@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 23, 2022
• Study Start: July 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: May 23, 2022

Record last verified: 2022-01

Locations

CN (1)