SWAN study

Not Applicable

Recruiting

• Conditions: Diabetic macular edema; Diabetic Macular Edema; D008269

• Registration Number: JPRN-jRCTs031230213
• Lead Sponsor: Murata Toshinori

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-10
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

General selection criteria
1.Patients who have received informed consent.
2.18 years older at the time of informed consent.
3.Patients with a confirmed diagnosis of diabetes( type 1 or type 2).
4.Patients whose HbA1c was 10% or less within 2 months before Day1.
5.Patients who have will to participate and be able to attend all scheduled visits and examins.

Critesia for selection of target eye
Designate only one eye as the target eye.
1.If both eyes are eligible, select the eye with the worse BCVA at screening will be used unless the principal investigators determine that the other eye is more appropriate for treatment. Patients with macular thickening due to DME, including the fovea, and CST of 325 micrometre or more by Spectralis SD-OCT, or 315 micrometre or more by Cirrus SD-OCT or Topcon SD-OCT(or other equivalent OCT) at screening.
2. Patients with 0.0625 to 0.7 in visual acuity test (decimal visual acuity) performed at screening.
3.Patients with sufficiently clear intermediate translucency, dilated pupils, and capable of high quality CFP imaging and other imaging examinations.

Exclusion Criteria

Exclusion criteria applied to the target eye
Patients who have
1.The high-risk PDR in the target eye
1) Vitreous hemorrhage or preretinal hemorrhage.
2) Neovascularization of 1/2 or more optic disc area than the optic disc area in ETDRS 7 directions under mydriasis detected by physical examination or CFP.
3) Neovascularization of more than one-third of the optic disc area detected on examination.
2.Tractional retinal detachment, preretinal fibrosis, vitreomacular traction syndrome, epiretinal membrane with foveal adhesion or macular structural disruption in the target eye.
3.An active rubeosis.
4. Poorly controlled glaucoma.
5.A history of retinal detachment or macular hole (stage 3 or 4)
6. An aphakic eye or intraocular lens inserted in the anterior chamber.
7.receiving intravitreal administration of anti-VEGF medication within 3 months before day1 (applicable to patients who have received intravitreal administration of anti-VEGF medication to the target eye). However, the inclusion rate of patients with a history of intravitreal administration of anti-VEGF medication should be less of 25% (=<17 cases).
8.Received PRP, macular laser treatment (focal, grid or micropulse), cataract surgery, steroid or YAG laser posterior capsulotomy within 3 months before day 1 for cataract surgery complications.
9.Undergone other intraocular surgery (e.g., corneal transplantation, glaucoma filtration surgery, pars plana vitrectomy, radiotherapy.
10.Received intravitreal or periocular (subtenon) steroid administration within 6 months before day1.
11. Received treatment for other retinal diseases that may leadto macular edema.
12.A history of intravitreal administration of faricimab.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change in bes-corrected visual acuity(BCVA) from baseline to 1 year(average of W52,56 and 60). BCVA at each measurement time point is decimal visual acuity, and the amount of change in BCVA is calculated in terms of the logarithm of the minimum angle of resolution (log MAR).