Clinical outcomes of Treat and Extend Regimen with Afilbercept with Diabetic Macular edema

Not Applicable

Recruiting

• Conditions: Diseases of the eye and adnexa

• Registration Number: KCT0007542
• Lead Sponsor: Kyung Hee University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 September 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients diagnosed with type 1 or type 2 diabetes over the age of 20 who have signed the informed consent form
2. Patients with diabetic macular edema that invaded the fovea; when the average retinal thickness in a concentric circle with a diameter of 1 mm centered on the fovea measured by optical coherence tomography (SD-OCT) is 300 µm or more
3. If the best corrected visual acuity (BCVA) of the patients is 24 or more
4. Patients who understand the process of this clinical trial, are cooperative, and are judged to be able to participate by the end of the clinical trial

Exclusion Criteria

1. Pregnant or lactating women
2. Patients participating in other clinical trials
3. In case of receiving anti-vascular endothelial growth factor treatment within the last 3 months
4. If the test subject has received steroid injection treatment within the last 6 months
5. In case of active proliferative diabetic retinopathy, iris neovascularization, vitreous hemorrhage, or traction retinal detachment in the subject
6. If the subject has active or past uveitis
7. History of intraocular surgery including cataract, vitrectomy, glaucoma, and scleral buckling within the last 3 months (excluding simple refractive surgery and plastic surgery)
8. Patients with structural damage to the fovea, so that it is difficult to expect improvement in visual acuity even after treatment for macular edema (retinal pigment epithelial atrophy, subretinal fibrosis and scarring, etc.)
9. Patients who have retinal diseases other than diabetic macular edema and require surgery or treatment during the trial period (advanced glaucoma, retinal vessel occlusion, retinal detachment, macular hole, macular degeneration, etc.)
10. Cerebrovascular disease, myocardial infarction diagnosed within the last year

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Best corrected visual acuity

Secondary Outcome Measures

Name	Time	Method
parameter of microvasculature, subfield thickness change, Diabetic Retinopathy Severity Scale (DRSS)