Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Purpose: To evaluate the acute changes in intraocular cytokines after intravitreal bevacizumab (IVB) in proliferative diabetic retinopathy.
Design: Prospective, open-label, controlled, randomized interventional clinical trial.
Participants: Twenty eyes of 28 consecutive patients who are scheduled for pars plana vitrectomy (ppV) for proliferative diabetic retinopathy were prospectively enrolled.
Methods: All patients were randomly assigned to receive IVB either at 2 or 7 days before ppV. Aqueous humor samples were taken from anterior chamber just before IVB and at the time of surgery. Multiplex cytokine array were used to assay various cytokines
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravitreal Avastin Day 2 | Experimental | randomized to either treatment with preoperative IVB 2 days before PPV (Group A) or 7 days before PPV (Group B). |
|
| Intravitreal Avastin Day 7 | Active Comparator | randomized to either treatment with preoperative IVB 2 days before PPV (Group A) or 7 days before PPV (Group B). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravitreal Avastin injection | Drug | Bevacizumab (1.25 mg in 0.05 ml) (Avastin; Genentech Inc., San Francisco, CA, USA) will be injected through the pars plana at 3.5 mm from the limbus, using 30 gauge needle. |
| Measure | Description | Time Frame |
|---|---|---|
| intraocular VEGF levels (pg/ml) in both groups (measured in aqueous humor), using multiplex beads immunoassay | Because we want to compare the differences between day 2 and day 7, vitrectomy will be performed at day 2 in group 1 and day 7 in group 2. That's why the time frame has two time point | At day 2 after IVB in Group 1, day 7 after IVB at group 2. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Won Ki Lee, MD. Ph.D | Contact | 82-2-2258-1188 | wklee@catholic.ac.kr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul Saint Mary's hospital | Recruiting | Seoul | Seoul | 137-070 | South Korea |
Not provided
| ID | Term |
|---|---|
| D048909 | Diabetes Complications |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided