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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by 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:
NCT01422018
First received: August 5, 2011
Last updated: September 22, 2011
Last verified: September 2011
  Purpose

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 Intervention
Diabetes Complications
Drug: Avastin (bevacizumab)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Seoul St. Mary's Hospital:

Primary Outcome Measures:
  • Changes in best-corrected visual acuity (BCVA) [ Time Frame: from month 0 to month 6 in monthly schedule (upto 6 months) ] [ Designated as safety issue: No ]
    ETDRS BCVA will be measured after 6 6 serial IVB.


Secondary Outcome Measures:
  • amount of hard exudates detected on fundus photography [ Time Frame: from month 0 to month 6 in bimonthly schedule (upto 6 months) ] [ Designated as safety issue: No ]
    on fundus photography

  • macular edema detected by optical coherent tomography [ Time Frame: from month 0 to month 6 in bimonthly schedule (upto 6 months) ] [ Designated as safety issue: No ]
    central subfield thickness will be measured.


Estimated Enrollment: 10
Study Start Date: August 2011
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Won Ki Lee, Pf., Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT01422018     History of Changes
Other Study ID Numbers: KC11MISI0439
Study First Received: August 5, 2011
Last Updated: September 22, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by 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
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Mellitus
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 August 20, 2014