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

Not Applicable

• Conditions: Diabetic Macular Edema

• Registration Number: JPRN-UMIN000018315
• Lead Sponsor: Department of Ophthalmology, Mie University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified