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Acute Changes in Intraocular Cytokines After Intravitreal Bevacizumab
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by Won Ki Lee, Seoul St. Mary's Hospital.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Seoul St. Mary's Hospital
Information provided by (Responsible Party):
Won Ki Lee, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier:
NCT01439178
First received: August 29, 2011
Last updated: September 21, 2011
Last verified: September 2011
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Purpose
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
| Condition | Intervention |
|---|---|
| Complications of Diabetes Mellitus | Drug: Intravitreal Avastin injection |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Acute Changes in Intraocular Cytokines After Intravitreal Bevacizumab |
Resource links provided by NLM:
Further study details as provided by Won Ki Lee, Seoul St. Mary's Hospital:
Primary Outcome Measures:
- intraocular VEGF levels (pg/ml) in both groups (measured in aqueous humor), using multiplex beads immunoassay [ Time Frame: At day 2 after IVB in Group 1, day 7 after IVB at group 2. ]
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
| Estimated Enrollment: | 28 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | November 2011 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intravitreal Avastin Day 2
randomized to either treatment with preoperative IVB 2 days before PPV (Group A) or 7 days before PPV (Group B).
|
Drug: Intravitreal Avastin injection
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.
|
|
Active Comparator: Intravitreal Avastin Day 7
randomized to either treatment with preoperative IVB 2 days before PPV (Group A) or 7 days before PPV (Group B).
|
Drug: Intravitreal Avastin injection
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with proliferative diabetic retinopathy who were scheduled for PPV for vitreous hemorrhage or tractional retinal detachment (TRD)
Exclusion Criteria:
- Eyes with any pharmacologic intervention on study eye within 6 months
- Eyes with panretinal photocoagulation on study eye within 3 months
- Eyes with any pharmacologic intervention on fellow eye within 3 months,
- History of ocular diseases other than diabetic retinopathy
- History of PPV on study eye
- History of systemic thromboembolic events including myocardial infarction and cerebrovascular accidents.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01439178
Please refer to this study by its ClinicalTrials.gov identifier: NCT01439178
Contacts
| Contact: Won Ki Lee, MD. Ph.D | 82-2-2258-1188 | wklee@catholic.ac.kr |
Locations
| Korea, Republic of | |
| Seoul Saint Mary's hospital | Recruiting |
| Seoul, Korea, Republic of, 137-070 | |
| Contact: Won ki Lee , M.D. Ph.D 82-2-2258-1188 wklee@catholic.ac.kr | |
Sponsors and Collaborators
Seoul St. Mary's Hospital
More Information
| Responsible Party: | Won Ki Lee, Preofessor, Seoul St. Mary's Hospital |
| ClinicalTrials.gov Identifier: | NCT01439178 History of Changes |
| Other Study ID Numbers: |
KC11MISI0391 |
| Study First Received: | August 29, 2011 |
| Last Updated: | September 21, 2011 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Complications Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Bevacizumab |
Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on August 18, 2017