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Clinical Trials/JPRN-UMIN000018315
JPRN-UMIN000018315
Completed
未知

Effect of Intravitreal Aflibercept Injection on Microaneurysm in Patients with Diabetic Macular Edema - Effect of Intravitreal Aflibercept Injection

Department of Ophthalmology, Mie University0 sites30 target enrollmentJuly 14, 2015

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Department of Ophthalmology, Mie University
Enrollment
30
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 14, 2015
End Date
TBD
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Department of Ophthalmology, Mie University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • 1\)Panretinal or macular laser photocoagulation (including grid photocoagulation) within 3 months 2\)Macular ischemia involving the center of the macula that is likely to preclude improvement in BCVA 3\)Vitreomacular traction evident biomicroscopically or on OCT 4\)Active proliferative diabetic retinopathy (characterized by any of the following: vitreous hemorrhage, preretinal hemorrhage, disc neovascularization, retinal neovascularization, and proliferative membrane or tractional retinal detachment with neovascularization) 5\)Glaucoma or optic atrophy 6\)History of any vitreous surgery 7\)Aphakia 8\)Treatment with any drug injected into the vitreous cavity or around the eye within 3 months 9\)Cataract that prevents fundus examinations required for the study 10\)Cataract surgery within 3 months 11\)Severe systemic conditions such as severe heart disease and cerebrovascular disorder 12\)Significant renal impairment defined as a serum creatinine level of over 2\.0 mg/dL or Stage 3B or greater overt nephropathy (including subjects requiring hemodialysis) 13\)Uncontrolled hypertension (systolic over 180, diastolic over110 mmHg) 14\)Uncontrolled diabetes mellitus (HbA1c over 10% \[NGSP]) 15\)Ocular inflammation including trace or above in the study eye 16\)Pregnant or breast\-feeding women.

Outcomes

Primary Outcomes

Not specified

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