Relationship between contrast sensitivity, vision-related quality of life and foveal microstructure in patients with diabetic macular edema following aflibercept therapy.
- Conditions
- Diabetic macular edema
- Registration Number
- JPRN-UMIN000020324
- Lead Sponsor
- niversity of Tsukuba
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Not provided
(1)The study eye is better than fellow eye (2)History of vitreoretinal surgery (3)Laser photocoagulation in the study eye within 90 days before Day 1 (4)More than 1 treatment with Direct laser/grid laser (5)Previous use of intraocular or periocular corticosteroids in the study eye within 120 days (6)Previous treatment with anti-angiogenic drugs in either eye within 90 days (7)Proliferative diabetic retinopathyin the study eye, (8)History of idiopathic or autoimmune uveitis (9)Any intraocular surgerywithin 90 days before Day 1 (10)Aphakia (11)Vitreomacular traction (12)Current iris neovascularization, vitreoushemorrhage, or tractional retinal detachment (13)Pre-retinal fibrosis (14)Structural damage to the center of the macula (15)History of endophthalmitis (16)Infectious blepharitis, keratitis,scleritis or conjunctivitis (17)Uncontrolled graucoma (18)High intraocular pressure in the study ey (19)High myopia (20)History of disease that can result in decreased visual acuity (21)Only one functional eye (22)Ocular media insufficient to obtain fundus and OCT images in the study eye (23)Serious systemic infection (24)Administration of systemic anti-angiogenic agents within 180 days before day 1 (25)Uncontrolled blood pressure (26)Uncontrolled diabetes mellitus (27)History of cerebrovascular accident and/or Myocardial infarction within 180 days before day 1 (28)Renal failure (29)Systemic disease patients who need treatment that may affect outcomes (30)Pregnant or breast-feeding women (31)Female subjects wish for a pregnancy within the intended treatment period (32)Allergy to fluorescein (33)Hypersensitive to aflibercept (34)Previous participation in any studies of investigational drugs within 30 days preceding Day 1 (35)Subjects who judged by a investigator to be inappropriate for the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Contrast sensitivity from baseline to 12 month
- Secondary Outcome Measures
Name Time Method Visual acuity from baseline to 12 month Central macular thickness(CMT) from baseline to 12 month Contrast sensitivity at every visit Vision-related quality of life (VR-QOL) from baseline to 12 month