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Effects of Intravitreal Ranibizumab for Macular Edema With Nonproliferative Diabetic Retinopathy

NCT02834663 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-05-22

Study results available
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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.

Conditions

  • Nonproliferative Diabetic Retinopathy

Interventions

DRUG

Lucentis

Local anesthesia with T-caine with Saline irrigation. Routine eye drap was done by potadine-cotton ball. Lucentis injected to vitreous cavity, finally dressing.

Sponsors & Collaborators

  • Novartis Korea Ltd.

    collaborator INDUSTRY

  • Wonkwang University Hospital

    lead OTHER

Principal Investigators

  • Yunsik Yang, MD, Ph D · Department of Ophthalmology, Wonkwang University School of Medicine

  • Seungjoon Lee, MD, Ph D · Study Official Affiliation should have no more than 80 characters.

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2019-02-28
Completion
2019-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02834663 on ClinicalTrials.gov