Status:
UNKNOWN
A Prospective Study of Ranibizumab in the Treatment of Postoperative Recurrent Vitreous Haemorrhage of Diabetic Retinopathy
Lead Sponsor:
Tianjin Medical University Eye Hospital
Collaborating Sponsors:
Hebei Provincial Eye Hospital
Cangzhou Eye Hospital
Conditions:
Diabetic Retinopathy
Postoperative Recurrent Vitreous Hemorrhage
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 st...
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 hemor...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05248334
Start Date
April 10 2022
End Date
December 30 2024
Last Update
August 12 2022
Active Locations (1)
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1
Tianjin medical university eye hosipital
Tianjin, Tianjin Municipality, China