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Effect of Intravitreal Bevacizumab on Focal Edema With Hard Exudates Secondary to Diabetic Retinopathy

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ClinicalTrials.gov Identifier: NCT01422018
Recruitment Status : Unknown
Verified September 2011 by Won Ki Lee, Seoul St. Mary's Hospital.
Recruitment status was:  Recruiting
First Posted : August 23, 2011
Last Update Posted : September 23, 2011
Sponsor:
Information provided by (Responsible Party):
Won Ki Lee, Seoul St. Mary's Hospital

Brief Summary:

Purpose: To evaluate the efficacy of intravitreal bevacizumab (IVB) on focal edema with hard exudates secondary to diabetic retinopathy.

Design: Prospective interventional case series. Participants: Ten eyes of 10 consecutive patients showing focal edema with hard exudates secondary to diabetic retinopathy which are not eligible for focal laser photocoagulation due to central location (< 500 µm from fovea).


Condition or disease Intervention/treatment
Diabetes Complications Drug: Avastin (bevacizumab)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : August 2011
Estimated Primary Completion Date : February 2012
Estimated Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: one arm for Anastin injection
intravitreal Avastin injection
Drug: Avastin (bevacizumab)
Bevacizumab (1.25 mg in 0.05 ml) (Avastin; Genentech Inc., San Francisco, CA, USA)



Primary Outcome Measures :
  1. Changes in best-corrected visual acuity (BCVA) [ Time Frame: from month 0 to month 6 in monthly schedule (upto 6 months) ]
    ETDRS BCVA will be measured after 6 6 serial IVB.


Secondary Outcome Measures :
  1. amount of hard exudates detected on fundus photography [ Time Frame: from month 0 to month 6 in bimonthly schedule (upto 6 months) ]
    on fundus photography

  2. macular edema detected by optical coherent tomography [ Time Frame: from month 0 to month 6 in bimonthly schedule (upto 6 months) ]
    central subfield thickness will be measured.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. patients of either gender aged > 18 years
  2. patients with type 2 diabetes
  3. central macular thickness > 300 µm on OCT
  4. eyes not eligible for focal laser photocoagulation due to the central location of hard exudates (< 500 µm)
  5. an area of retinal thickening less than 2 disc areas in diameter
  6. 67% or more of leakage associated with microaneurysms

Exclusion Criteria:

  1. eyes with history of laser photocoagulation or pharmacological intervention for DME on study eye
  2. eyes with any pharmacologic intervention on fellow eye within 6 months
  3. history of ocular diseases other than diabetic retinopathy
  4. surgical history other than cataract extraction with intraocular lens implantation
  5. panretinal photocoagulation within 3 months of enrollment
  6. media opacity
  7. any thromboembolic event within 6 months, or evidence of active cardiac ischemia on electrocardiogram (ECG) at time of screening.

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): NCT01422018


Contacts
Contact: Sohee Jeon, MD 82-10-7176-1357 soheeeee@gmail.com
Contact: Won ki Lee, DM, Ph.D 82-2-2258-1188 wklee@catholic.ac.kr

Locations
Korea, Republic of
Seoul St Mary's hospital Recruiting
Seocho, Seoul, Korea, Republic of, 137-070
Contact: Sohee Jeon, MD    82-10-7176-1357    soheeeee@gmail.com   
Sponsors and Collaborators
Seoul St. Mary's Hospital
Investigators
Principal Investigator: Won ki Lee, MD Ph.D Seoul St. Mary's Hospital

Responsible Party: Won Ki Lee, Pf., Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT01422018     History of Changes
Other Study ID Numbers: KC11MISI0439
First Posted: August 23, 2011    Key Record Dates
Last Update Posted: September 23, 2011
Last Verified: September 2011

Keywords provided by Won Ki Lee, Seoul St. Mary's Hospital:
clinically significant macular edema
diabetic macular edema
focal edema
focal laser photocoagulation
hard exudates
intravitreal bevacizumab

Additional relevant MeSH terms:
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents