Efficacy and safety of intravitreal Ziv-aflibercept injection for the treatment of refractory diabetic macula edema

Phase 3

• Conditions: Diabetic macular edemaDiabetes mellitus; Diabetic macular edema; Ophthalmic complications of diabetes mellitus; Ziv-aflibercept; Bevacizumab; intravitreal injection; anti-vascular endothelial growth factors

• Registration Number: TCTR20191130001
• Lead Sponsor: Faculty of Medicine, Khon Kaen University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-30
• Study Completion: 2021-05-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Terminated (Halted Prematurely)
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

1. Patients with diabetic macular edema with history of intravitreal Bevacizumab injection at least 3 injections within the past 4 months and are refractory to the treatment
2. During the last 2 intravitreal Bevacizumab injection, the decrease in central subfield thickness is less than 10% from the baseline
3. Central subfield thickness is greater than 300 micrometer at the beginning of the study
4. The glycosylated hemoglobin level in plasma is less than 12%

Exclusion Criteria

1. One-eyed patient
2. Active Ocular infection (including endophthalmitis, infectious conjunctivitis, blepharitis, etc.)
3. Ophthalmic conditions which affect the patients' visual acuity or makes fundus photography impossible. (for example, corneal scar, moderate to severe cataract, vitreous haemorrhage, massive retinal haemorrhage)
4. Patients with history of intravitreal anti-VEGF injection other than Bevacizumab.
5. Patients with history of intravitreal steroid injection in the past 6 months
6. Patients with history of vitreoretinal surgery
7. Patients with history of ophthalmic laser procedure in the past 6 months
8. Severe hypertension (defined as systolic blood pressure >180 mmHg, or diastolic blood pressure >110 mmHg)
9. Renal disease requiring renal replacement therapy or kidney transplant
10. History of ischemic heart disease
11. History of stroke
12. Pregnant women, lactating women, or women with intended pregnancy in the next 6 months
13. Patients who are unable to visit monthly for 6 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Best-corrected visual acuity 6 months LogMAR

Secondary Outcome Measures

Name	Time	Method
Central subfield thickness 6 months Optical Coherence Tomography,complications 6 months observation