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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
Sponsor:
Information provided by (Responsible Party):
Won Ki Lee, Seoul St. Mary's Hospital

Study Description
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Brief Summary:

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 Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources

Arms and Interventions
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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).
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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



Eligibility Criteria
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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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Information from the National Library of Medicine

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


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
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