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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
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
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. ]

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
No Changes Posted
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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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01439178
KC11MISI0391
Yes
Not Provided
Not Provided
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