Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hebei Provincial Eye Hospital | OTHER |
| Cangzhou Eye Hospital | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab group | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab Injection | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The cleaning time of postoperative recurrent vitreous hemorrhage | Record VH by B scan and funds examination | two months |
| Visual acuity | ETDRS Alphabet Chart | six moths |
| Measure | Description | Time Frame |
|---|---|---|
| Macular thickness | optical coherence tomography (OCT); TOPCON 3D-OCT-2000; Topcon Corporation, Tokyo, Japan | six moths |
| Vitreous hemorrhage recurrence | B scan and funds examination |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bojie Hu | Contact | 13612130943 | bhu07@tmu.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin medical university eye hosipital | Recruiting | Tianjin | Tianjin Municipality | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| PPV | 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. |
|
|
| six moths |
| The number of pars plana vitrectomy | Record the number of pars plana vitrectomy | six moths |
| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided