Investigation of the treat-and-extend protocol with Aflibercept in combination with retinal photocoagulation in patients with diabetic macula edema(extension study)

JRCT ID: jRCTs031180356

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Diabetic macular edema
• Date of first enrollment: 01/09/2017
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Aflibercept (genetical recombination) will be administered by intravitreal injection at a dose of 2 mg (0.05 mL) at intervals of at least 4 weeks. Direct/Grid photocoagulation (direct photocoagulation of capillary aneurysms/Gird photocoagulation to retinal nonperfused area) is also carried out.

Outcome(s)

• Primary Outcome: Central retinal thickness (CRT) measured on optical coherence tomography (OCT) and visual acuity.
• Secondary Outcome: Number of intravitreal injections of aflibercept and safety.

Key inclusion & exclusion criteria

• Age minimum: 20age
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Patients with type 1 or type 2 diabetes mellitus 20 years of age or older
2.Patients with fovea involving diabetic macular edema (judged with central subfield thickness on OCT)
3.Patients with reduced visual acuity associated with diabetic macular edema
4.Patients whose best corrected visual acuity is more than 20/320 (24 letters) by the ETDRS visual acuity test.
5.Patients with a central retinal thickness (CRT) of 300 um or more on the OCT retinal map (measured in mm) as an objective finding
6.Patients who are willing and able to visit the study site, as scheduled, and undergo scheduled examinations in this study
7.Patients who can provide written voluntary consent to participate in this study after receiving adequate explanation

Exclude criteria

The condition of the fellow eye is worse than that of the study eye.
A history of vitreous surgery, including encircling buckling
Any retinal photocoagulation treatment within 90 days
Topical corticosteroid treatment within 120 days
Treatment with injection of any anti VEGF agent into the study eye within 90 days
Highly active, proliferative diabetic retinopathy in the study eye
A history of uveitis
Aphakic eyes
A history of any intraocular surgery in the study eye within the previous 90 days
It is considered difficult to improve visual acuity due to morphological changes
Glaucoma with poor IOP control, a history of glaucoma filtering surgery, or scheduled filtering surgery in the study eye
IOP of the study eye: more than 25 mmHg
Myopia of -8D or greater
Study eye is the last eye
Optic media in which it is difficult to obtain fundus photographs or OCT images
Severe systemic infections at baseline
Systemic anticoagulation therapy within 180
Poorly controlled diabetes mellitus
Poorly controlled hypertension
A history of cerebrovascular accident and/or myocardial infarction within 180 days
Patients on dialysis and patients with renal failure requiring dialysis

Related Information

• Primary Sponsor: Murata Toshinori
• Source(s) of Monetary Support: Bayer Yakuhin, Ltd.
• Secondary ID(s): UMIN000027771