Investigation of the treat-and-extend protocol with Aflibercept in combination with retinal photocoagulation in patients with diabetic macula edema(extension study)
- Conditions
- Diabetic macula edema
- Registration Number
- JPRN-UMIN000027771
- Lead Sponsor
- Shinshu University Department of ophthalmology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 20
Not provided
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 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Central retinal thickness (CRT) measured on optical coherence tomography (OCT) and visual acuity
- Secondary Outcome Measures
Name Time Method umber of intravitreal injections of aflibercept and safety