Ziv-aflibercept versus bevacizumab for treatment of CRVO with macular edema..

• Conditions: central retinal vein occlusion; macular edema; central subfield thickness more than 300 micron

• Registration Number: TCTR20191205008
• Lead Sponsor: Invitation research fund Faculty of medicine, Khonkaen University

Brief Summary

In this study, both IVZ and IVB showed significant visual improvement and CST reduction. When comparing the groups, ziv-aflibercept had insignificantly better visual and anatomical outcomes than bevacizumab in the treatment of ME secondary to CRVO. The mean number of injections was lower in the ziv-aflibercept group; however, the difference was not statistically significant. These results demonstrate the potential of ziv-aflibercept for the treatment of ME due to CRVO.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-05
• Study Completion: 2021-01-29
• Results First Posted: 2023-09-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Terminated (Halted Prematurely)
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Diagnosis of CRVO with macular edema
- CST > 300 micron (by SD-OCT)

Exclusion Criteria

1. one-eyed patient
2. external ocular infection ex. conjunctivitis , hordeolum and blepharitis
3. diabetic macular edema , age-related macular degeneration, epimacular membrane, vitreomacular traction and macular atrophy
4. History of laser within 6 mo
5. History of intraocular surgery within 6 mo (cataract sx, glaucoma sx)
6. History of intravitreal injection of steroid within 6 mo
7. History of intravitreal injection of anti-VEGF within 8 wk
8. Can't take fundus photo and OCT due to cataract, vitreous hemorrhage, corneal scar and pupillary constriction
9. U/D : myocardial infarction, stroke and uncontrolled HT
10. uncooperative patient ex. spine disease
11. pregnancy / planning of pregnancy within 12 mo
12. can't follow-up

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
visual acuity at the beginning of study and mo 6 ETDRS

Secondary Outcome Measures

Name	Time	Method
central subfield thickness at the beginning of study and mo 6 by SD-OCT,number of injection at the beginning of study until mo 6 number,adverse effect at pose-dose until mo 6 type