Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-28 @ 12:12 AM
Study NCT ID:
NCT05248334
Status:
UNKNOWN
Last Update Posted:
2022-08-12
First Post:
2022-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Study of Ranibizumab in the Treatment of Postoperative Recurrent Vitreous Haemorrhage of Diabetic Retinopathy
Sponsor:
Tianjin Medical University Eye Hospital
Organization:
Study Overview
Official Title:
Ranibizumab in the Treatment of Postoperative Recurrent Vitreous Haemorrhage of Diabetic Retinopathy
Status:
UNKNOWN
Status Verified Date:
2022-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: