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Acute Changes in Intraocular Cytokines After Intravitreal Bevacizumab

This study is currently recruiting participants.
Verified September 2011 by Seoul St. Mary's Hospital
Sponsor:
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
History of Changes

August 29, 2011
September 21, 2011
August 2011
November 2011   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]

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
Same as current
Complete list of historical versions of study NCT01439178 on ClinicalTrials.gov Archive Site
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Acute Changes in Intraocular Cytokines After Intravitreal Bevacizumab
Acute Changes in Intraocular Cytokines After Intravitreal Bevacizumab

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
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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Complications of Diabetes Mellitus
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.
  • 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).
    Intervention: Drug: Intravitreal Avastin injection
  • 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).
    Intervention: Drug: Intravitreal Avastin injection
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
28
November 2011
November 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact: Won Ki Lee, MD. Ph.D 82-2-2258-1188 wklee@catholic.ac.kr
Korea, Republic of
 
NCT01439178
KC11MISI0391
Yes
Won Ki Lee, Seoul St. Mary's Hospital
Seoul St. Mary's Hospital
Not Provided
Not Provided
Seoul St. Mary's Hospital
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP