NIPH Clinical Trials Search

JRCT ID: jRCTs031180356

Registered date:18/03/2019

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

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedDiabetic macular edema
Date of first enrollment01/09/2017
Target sample size20
Countries of recruitment
Study typeInterventional
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.


Primary OutcomeCentral retinal thickness (CRT) measured on optical coherence tomography (OCT) and visual acuity.
Secondary OutcomeNumber of intravitreal injections of aflibercept and safety.

Key inclusion & exclusion criteria

Age minimum20age
Age maximumNot applicable
Include criteria1.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 criteriaThe 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


Public contact
Name Yuichi Toriyama
Address 3-1-1 Asahi, Matsumoto Nagano Nagano Japan 390-8621
Telephone +81-263-37-2664
Affiliation Shinshu University Hospital
Scientific contact
Name Toshinori Murata
Address 3-1-1 Asahi, Matsumoto Nagano Nagano Japan 390-8621
Telephone +81-263-37-2664
Affiliation Shinshu University Faculty of medicine