A Prospective Study of Ranibizumab in the Treatment of Postoperative Recurrent Vitreous Haemorrhage of Diabetic Retinopathy

NCT ID: NCT05248334

Last Updated: 2022-08-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-10
• Study Completion Date: 2024-12-30

Brief Summary

Diabetic retinopathy (DR) is one of the main complications in diabetes, the proliferative diabetic retinopathy (PDR) is the most important one of the reasons leading to decreased vision, PDR is the stage of clinical intervention. Pars plana vitrectomy (PPV) is an effective treatment for PDR, while vitreous haemorrhage (VH) is a common complication after PPV, with incidence ranging from 11.8% to 75%, and is the main cause of reoperation. Anti-Vascular endothelial growth factor (VEGF) therapy for vitreous hemorrhage can inhibit neovascularization and prevent recurrent vitreous haemorrhage after absorption. Previous studies have found that anti-VEGF is a safe and effective treatment for postoperative recurrent VH. In consideration of the psychological and economic factor of patients, this study intends to observe the effectiveness of single vitreous injection of Ranibizumab in the treatment of postoperative recurrent VH on the basis of previous clinical work. Compare the visual acuity, macular thickness, VH recurrence and patient satisfaction between the Ranibizumab group and the PPV group by randomized grouping.To observe the effective rate and clearance time of recurrent VH after Ranibizumab treatment and whether it can effectively reduce the rate of PPV. To provide clinical guidance for the precise treatment of PDR patients, the treatment of PDR patients has important clinical significance and social and economic significance.

Detailed Description

1. Patients with proliferative diabetic retinopathy who underwent vitrectomy were collected. Vitreous hemorrhage was completely cleared for more than 1 week after surgery, and vitreous recurrent hemorrhage was not absorbed for more than 4 weeks (grade 2 and above). If the patient has recurrent vitreous hemorrhage or symptoms suggestive of recurrent vitreous hemorrhage, ultrasound at 10mhz posterior segment and 20mhz anterior segment are performed by an experienced sonographer. Patients were randomly assigned to PPV group or Ranibizumab group according to the order in which they came to visit and according to a random number table.

2. PPV group: PPV and pan retinal photocoagulation; in the Ranibizumab group, Ranibizumab was injected and pan retinal photocoagulation was performed during ocular fundus could observed, and observation for 4 weeks. If vitreous hemorrhage was not absorbed/vitreous hemorrhage aggravation/proliferation membrane formation/ retinal detachment, PPV was performed.

3. Collected information: best corrected visual acuity, slit lamp and fundus examination, intraocular pressure, B-ultrasound, macular thickness, the date of recurrent vitreous hemorrhage and treatment, vitreous cleaning time, the time of significant improvement of visual acuity, times and duration of vitreous hemorrhage. The follow-up time was 1 day, 2 weeks, 1 month, 2 months, 4 months and 6 months, respectively. To observe the effectiveness of Ranibizumab in the treatment of postoperative recurrent vitreous hemorrhage and reduce the number of vitrectomy.

Conditions

Diabetic Retinopathy; Postoperative Recurrent Vitreous Hemorrhage; Pars Plana Vitrectomy; Ranibizumab

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ranibizumab group

The Ranibizumab group was treated with one intravitreal injection of 0.5 mg/0.05 ml ranibizumab (Lucentis, Basel, Novartis) at baseline. While additional panretinal photocoagulation was performed if there was sufficient space and view to fill in the previously untreated areas, if needed. Repeated injections will be given after 4 weeks when the clearing of VH was incomplete (for a maximum of two injections).

If vitreous hemorrhage was not absorbed/vitreous hemorrhage aggravation/proliferation membrane formation/retinal detachment after 4 weeks of observation, the treatment was considered failed and PPV was performed.

Group Type: EXPERIMENTAL

Ranibizumab Injection

Intervention Type: DRUG

The Ranibizumab group was treated with one intravitreal injection of 0.5 mg/0.05 ml ranibizumab (Lucentis, Basel, Novartis) at baseline. While additional panretinal photocoagulation was performed if there was sufficient space and view to fill in the previously untreated areas, if needed. Repeated injections will be given after 4 weeks when the clearing of VH was incomplete (for a maximum of two injections).

If vitreous hemorrhage was not absorbed/vitreous hemorrhage aggravation/proliferation membrane formation/retinal detachment after 4 weeks of observation, the treatment was considered failed and PPV was performed.

PPV group

Vitrectomy to remove vitreous hemorrhage and take additional panretinal photocoagulation. If vitreous hemorrhage was not absorbed/vitreous hemorrhage aggravation/proliferation membrane formation/tractive retinal detachment after 4 weeks of observation, the treatment was considered failed and PPV was performed.

Group Type: ACTIVE_COMPARATOR

PPV

Intervention Type: PROCEDURE

Vitrectomy to remove vitreous hemorrhage and take additional panretinal photocoagulation. If vitreous hemorrhage was not absorbed/vitreous hemorrhage aggravation/proliferation membrane formation/tractive retinal detachment after 4 weeks of observation, the treatment was considered failed and PPV was performed.

Interventions

Ranibizumab Injection

The Ranibizumab group was treated with one intravitreal injection of 0.5 mg/0.05 ml ranibizumab (Lucentis, Basel, Novartis) at baseline. While additional panretinal photocoagulation was performed if there was sufficient space and view to fill in the previously untreated areas, if needed. Repeated injections will be given after 4 weeks when the clearing of VH was incomplete (for a maximum of two injections).

If vitreous hemorrhage was not absorbed/vitreous hemorrhage aggravation/proliferation membrane formation/retinal detachment after 4 weeks of observation, the treatment was considered failed and PPV was performed.

Intervention Type: DRUG

PPV

Vitrectomy to remove vitreous hemorrhage and take additional panretinal photocoagulation. If vitreous hemorrhage was not absorbed/vitreous hemorrhage aggravation/proliferation membrane formation/tractive retinal detachment after 4 weeks of observation, the treatment was considered failed and PPV was performed.

Intervention Type: PROCEDURE

Other Intervention Names

Panretinal photocoagulation; Panretinal photocoagulation

Eligibility Criteria

Inclusion Criteria

• Voluntary and able to sign an informed consent form
• Age ≥18 years
• Documented diagnosis of diabetes mellitus (type I or type II diabetes) as defined by the American Diabetes Association or World Health Organization criteria and glycosylated hemoglobin ≤10% within 2 months
• Willing and able to complete all planned visits and evaluations
• Complete Panretinal photocoagulation
• Retinal repositioning
• Complete postoperative vitreous hemorrhage clearance for more than 1 week and non-absorption of recurrent vitreous hemorrhage for more than 4 weeks (grade 2 and above)
• Early postoperative period (1 week to 1 month postoperatively) and delayed postoperative period (4 weeks to 12 months postoperatively)

Exclusion Criteria

• Patients with less than 6 months of follow-up
• Silicone oil filling
• Other retinal causes of vitreous hemorrhage
• Tractive retinal detachment, pre-retinal proliferative membrane
• Iris redness, neovascular glaucoma
• History of glaucoma
• Ocular inflammation
• Any other intraocular surgery (e.g., corneal transplantation, glaucoma filtration, corneal transplantation therapy, etc.)
• Patients with best corrected visual acuity manual or worse, patients with a single eye
• Previous cerebrovascular or thromboembolic events, hypertensive disorders, renal disease, current use of anticoagulants

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Provincial Eye Hospital

OTHER

Sponsor Role: collaborator

Cangzhou Eye Hospital

UNKNOWN

Sponsor Role: collaborator

Tianjin Medical University Eye Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bojie Hu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tianjin medical university eye hosipital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Bojie Hu

Role: CONTACT

bhu07@tmu.edu.cn

13612130943

Facility Contacts

Bojie Hu

Role: primary

bhu07@tmu.edu.cn

13612130943

Other Identifiers

TianjinMUEHhbj123

Identifier Type: -

Identifier Source: org_study_id