SWAN study

JRCT ID: jRCTs031230213

Registered date:10/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Diabetic macular edema
• Date of first enrollment: 16/08/2023
• Target sample size: 70
• Study type: Interventional

Intervention(s)

Patients receive faricimab 6.0 mg intravitreally for 2 years.
In the induction phase, all patients receive faricimab once every 4 weeks(Q4W) for 4 consecutive doses. However, the 4th dose is omitted depending on disease activity.
Dosing schedule after W12 is determined based on disease activity.
Disease activity is defined as CST=> 325 micrometer and significant pathologic IRF or SRF. In addition, determination of disease activity is performed only in the target eye.

Outcome(s)

• Primary Outcome: 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).

Secondary Outcome

The change from baseline in BCVA (log MAR) at W52, 56 and 60 at the nearest post-treatment visit. (Nearest post-treatment visits is W56 and 60, if patients received dosing at W52 or 56 respectively, otherwise W52.)

The change from baseline in central region retinal thickness (CST) at 1 year after treatment started.

The following items at each time point
-BCVA and the change from baseline in BCVA (log MAR)
-Proportion of patients with BCVA as follows
- Improvement of => 0.3 log MAR from baseline
-Did not worsen by => 0.3 log MAR from baseline
-Decimal visual acuity =>0.5, 0.7, 1.0 respectively
-Decimal visual acuity =<0.1
-Percentage of patients with visual acuity better than before DME.
-CST and CST change from baseline
-Proportion of patients without DME (CST<325 micrometer [315 micrometer depending on device])
-Percentage of patients without intraretinal fluid(IRF), percentage of patients without subretinal fluid (SRF), or both.
-Proportion of patients with only IRF, SRF or both.
-Percentage of patients with=>2 grades of improvement in DRS from baseline on ETD RS DRSS.
-Percentage of patients with DRS improvement of=> 2 or 3 grades from baseline on ETDRS DRSS.
-Percentage of patients with new onset PDR.
-Percentage of patients with new onset neovascular glaucoma.
-Percentage of patients by administration interval.
-Mean number of doses of faricimab.
-Amount and percent change from baseline in the NEI VFQ-25 composite score.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Murata Toshinori

Source(s) of Monetary Support

CHUGAI PHARMACEUTICAL CO., LTD.
Medical Affairs Division