Effects of Intravitreal Ranibizumab for Macular Edema With Nonproliferative Diabetic Retinopathy

• Status: Completed
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Title of study:

Effects of Ranibizumab to delay or regression non-proliferative diabetic retinopathy(NPDR) with DME assessed by microaneurysm changes: A pilot study Objectives Diabetic retinopathy (DR) is a major cause of visual impairment. Anti-vascular endothelial growth factors have demonstrated therapeutic benefits in diabetic macular edema (DME). We aimed to prospectively analyze the effects of early intensive treatment using intravitreal ranibizumab (IVR) injections in nonproliferative diabetic retinopathy patients with macular edema.

Primary objective:

To investigate other efficacy endpoints including other visual acuity, anatomical change in mild-to-moderate NPDR with DME after intravitreal Ranibizumab injection from baseline through 6 months after treatment.

Secondary objectives:

To compare microvascular changes assessed by microaneurysm counts and perifoveal non-perfusion area changes and safty in eyes of mild-to-moderate NPDR with DME after intravitreal Ranibizumab injection from baseline through 6 months after treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wonkwang University Hospital
• Collaborator: Novartis Korea Ltd.
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

• Patients (Male & female) ≥40 years of age

• Type 2 DM

• Best corrected visual acuity ≥ 20/200 (Snellen equivalent using Early Treatment Diabetic Retinopathy Study chart)

• central retinal thickness of ≥300 µm on optical coherence tomography

• nonproliferative diabetic retinopathy (NPDR) with diabetic macular edema

Exclusion Criteria:

• proliferative diabetic retinopathy

• Vitreous hemorrhage

• previous history of vitreoretinal surgery, post-cataract operation status (≤4 months before participation in this study)

• prior treatment with anti-VEGF drugs, intraocular corticosteroids, and/or retinal laser application

• Uncontrolled hypertension.

• Uncontrolled glaucoma.

• If both eyes met the study inclusion criteria, the more severely affected eye was selected