Prospective clinical trial of Eylea combined with Vitrectomy for DME

JRCT ID: jRCTs031210235

Registered date:11/08/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: diabetic macular edema
• Date of first enrollment: 11/08/2021
• Target sample size: 10
• Study type: Interventional

Intervention(s)

Vitrectomy is performed to the case of diabetic macular edema with inadequate effects of anti-VEGF agents.
Observation is performed every 4 weeks.
Administer anti-VEGF agent if retreatment criteria are met.

Outcome(s)

• Primary Outcome: Change in best corrected visual acuity (logMAR) from baseline (before vitrectomy)

Secondary Outcome

Change in central retinal thickness from baseline (before vitrectomy)
Number of anti-VEGF treatment after vitrectomy

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1) Japanese male and female of 20 to 80 years
2) DME with central involvement in the study eye
3) Patients with a central retinal thickness (CRT) of 400 micrometer or more after 3 consecutive injections of Eylea, or patients with a CRT increases of 30% or more within 16 weeks even if the CRT decreased to less than 400 micrometers after 3 consecutive injections of Eylea
In cases that both eyes meet inclusion criteria and vitrectomy is performed to both eyes, the subject is only one eye, and in principle, the eye to be operated on first is the subject eye

Exclude criteria

1) New patient
2) Last-eye patient (one-eye blindness)
3) Poor glycemic control (HbA1c 9.0% or higher)
4) Uncontrolled hypertension (systolic blood pressure> 180 mmHg or diastolic blood pressure> 110 mmHg)
5) Dialysis patients or patients with severe renal dysfunction who are considering the introduction of dialysis
6) Patients with thickened epiretinal membrane or posterior vitreous membrane in the study eye, without retinal edema in their OCT images, with less than 10% improvement in central retinal thickness by 3 consecutive injections of anti-VEGF agents
7) Patients with cataracts that clearly affect visual acuity in the study eye
8) Patients who underwent panretinal photocoagulation within 180 days of vitrectomy in the study eye
9) Patients who received intraocular or periocular steroids within 120 days of vitrectomy in the study eye
10) Patients who underwent cataract surgery or other intraocular surgery within 90 days of vitrectomy in the study eye
11) Patients who have a history of filtration surgery for the treatment of glaucoma in the study eye, or who are expected to need it in the future
12) Patients with a history of idiopathic or autoimmune uveitis in the study eye
13) Patients with iris neovascularization and tractional retinal detachment in the study eye
14) Patients with central macular structural damage such as retinal pigment epithelial atrophy, subretinal fibrosis or scarring, severe macular ischemia or organic hard macula that interferes with visual acuity improvement after macular edema disappears in the study eye
15) Patients with marked fluctuations in symptoms and findings
16) Patients who cannot understand the contents and procedures of this study
17) Patients who are participating in the other research
18) Patients who have difficulty going to the hospital
19) Patients who are judged by the investigator or the investigator to be unsuitable for conducting this study safely

Related Information

• Primary Sponsor: Baba Takayuki
• Secondary Sponsor: Chiba University Hospital