Comparison between non-switching and early-switching therapy to aflibercept in diabetic macula edema with suboptimal response to prior treatment with bevacizumab.

Not Applicable

• Conditions: Patient with center- involved DME with suboptimal response to 3 monthly initial bevacizumabinjections; Diabetic macula edema, DME, bevacizumab, aflibercept, central subfield thickness

• Registration Number: TCTR20190515002
• Lead Sponsor: /A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-15
• Study Completion: 2021-09-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

- Patient with center-involved DME with suboptimal response to 3 monthly initial bevacizumab
injections (defined as persistent DME in central fovea, intraretinal cystoid space or subretinal
fluid persisted, with central subfield thickness ≥305 microns in women and ≥320 microns in
men by Heidelberg Spectralis OCT after 3 consecutive injection of bevacizumab)
- Age > 18 years old
- Visual acuity 6/7.5 †6/240 (20/25 †20/800)
- No history of prior intravitreal injections or laser to treat macular edema

Exclusion Criteria

- Patients with other disorders affecting macular thickness such as retinal vein occlusion,
vitreomacular traction, epiretinal membrane, macular hole, choroidal neovascularization and
medication known to cause macular edema
- Patients with active proliferative diabetic retinopathy and neovascular glaucoma
- Patients with ocular media opacity that preclude OCT imaging
- Patients who cannot comply to the 3 monthly follow-up visits
- Patients with recent onset of thromboembolic events such as stroke and myocardial infarction
within 6 months
- Pregnant women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
visual acuity (VA) gain in non-switching therapy with early-switching to aflibercept therapy in DME every 4 weeks and 1 month after last injection unpaired T-test

Secondary Outcome Measures

Name	Time	Method
Central subfield thickness(CST), changes in VA and CST between the two groups, the predicting factor every 4 weeks and 1 month after last injection unpaired T-test,Categorical data-individual counts and proportions