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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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acute Changes in Intraocular Cytokines After Intravitreal Bevacizumab

Resource links provided by NLM:

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

Further study details as provided by 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. ] [ 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



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
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: Korea: Food and Drug Administration

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
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013