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

NCT01422018 | Unknown DMC

• 1 other identifier: KC11MISI0439
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetes Complications

Keywords

clinically significant macular edema; diabetic macular edema; focal edema; focal laser photocoagulation; hard exudates; intravitreal bevacizumab

Outcome Measures

Primary Outcomes (1)

• Changes in best-corrected visual acuity (BCVA)

  ETDRS BCVA will be measured after 6 6 serial IVB.

  from month 0 to month 6 in monthly schedule (upto 6 months)

Secondary Outcomes (2)

• amount of hard exudates detected on fundus photography

  from month 0 to month 6 in bimonthly schedule (upto 6 months)

• macular edema detected by optical coherent tomography

  from month 0 to month 6 in bimonthly schedule (upto 6 months)

Study Arms (1)

one arm for Anastin injection

EXPERIMENTAL

intravitreal Avastin injection

Drug: Avastin (bevacizumab)

Interventions

Avastin (bevacizumab) DRUG

Bevacizumab (1.25 mg in 0.05 ml) (Avastin; Genentech Inc., San Francisco, CA, USA)

one arm for Anastin injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Seoul St. Mary's Hospital: lead

Study Sites (1)

Seoul St Mary's hospital

Seocho, Seoul, 137-070, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetes Complications

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Won ki Lee, MD Ph.D

  Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sohee Jeon, MD

CONTACT

82-10-7176-1357; soheeeee@gmail.com

Won ki Lee, DM, Ph.D

CONTACT

82-2-2258-1188; wklee@catholic.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pf.

Study Record Dates

• First Submitted: August 5, 2011
• First Posted: August 23, 2011
• Study Start: August 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: September 23, 2011

Record last verified: 2011-09

Locations

KR (1)