Acute Changes in Intraocular Cytokines After Intravitreal Bevacizumab
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ClinicalTrials.gov Identifier: NCT01439178 |
Recruitment Status
: Unknown
Verified September 2011 by Won Ki Lee, Seoul St. Mary's Hospital.
Recruitment status was: Recruiting
First Posted
: September 23, 2011
Last Update Posted
: September 23, 2011
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Complications of Diabetes Mellitus | Drug: Intravitreal Avastin injection | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 28 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Acute Changes in Intraocular Cytokines After Intravitreal Bevacizumab |
Study Start Date : | August 2011 |
Estimated Primary Completion Date : | November 2011 |
Estimated Study Completion Date : | November 2011 |

Arm | Intervention/treatment |
---|---|
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).
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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.
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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).
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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.
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- 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

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01439178
Contact: Won Ki Lee, MD. Ph.D | 82-2-2258-1188 | wklee@catholic.ac.kr |
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 |
Responsible Party: | Won Ki Lee, Preofessor, Seoul St. Mary's Hospital |
ClinicalTrials.gov Identifier: | NCT01439178 History of Changes |
Other Study ID Numbers: |
KC11MISI0391 |
First Posted: | September 23, 2011 Key Record Dates |
Last Update Posted: | September 23, 2011 |
Last Verified: | September 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 |