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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01053858
Other study ID # 2009_10_12
Secondary ID
Status Completed
Phase N/A
First received January 14, 2010
Last updated January 20, 2010
Start date January 2008
Est. completion date January 2010

Study information

Verified date January 2010
Source Hallym University Medical Center
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To evaluate the effect of intravitreal bevacizumab with intravitreal triamcinolone for the treatment of central retinal vein occlusion (CRVO) presenting poor visual acuity.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date January 2010
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- central macular thickness of more than 250 µm and baseline visual acuity of 20/200 or worse than 20/200 in patient with central retinal vein occlusion

Exclusion Criteria:

- previous treatment such as intravitreal injection, subtenon injection, or laser photocoagulation since the time of onset

- Patients with a history of glaucoma, neovascular glaucoma, diabetic retinopathy, and macular disorders

- neovascularization on the disc or elsewhere or rubeosis

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
intravitreal injection
intravitreal bevacizumab( 1.25 mg) or triamcinolone( 4mg) injection

Locations

Country Name City State
Korea, Republic of keoung ik Na Chuncheon Anyang

Sponsors (1)

Lead Sponsor Collaborator
Hallym University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary best corrected visual acuity baseline, 1 month, 2 months, 3 months, 6 months, 12 months Yes
Secondary central macular thickness by optical coherence tomography baseline, 1 month, 2 months, 3 months, 6 months 12months Yes