Effect of Intravitreal Ranibizumab Injection With Retinal Vein Occlusion (RVO)

Novartis Korea Ltd.40 enrolled

Overview

The purpose of this study is to evaluate the effects of intravitreal Lucentis® (Ranibizumab) and investigate the anatomical and functional improvement following this treatment in patients with macular edema due to retinal vein occlusion (RVO).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Macular Edema Retinal Vein Occlusion

Interventions

ranibizumabDRUG

ranibizumab 0.5mg (0.05ml volume), intravitreal injection first 3 injection every 4 weeks additional injection (optional) according to the judgement of doctor

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Signed written informed consent * Patients with macular edema due to RVO (confirmed by fundus photography, fluorescein angiography, OCT) * Male and female aged from 18 to 70 * Baseline best-corrected visual acuity (BCVA) in the study eye was from 20/400 to 20/30 using ETDRS chart Exclusion Criteria: * Additional eye disease that could compromise VA * Ocular inflammation * Intraocular surgery ≤ 1 month before day 0 * Uncontrolled glaucoma * Prior treatments with laser photocoagulation or other intervention for macular edema due to BRVO * Patients aged under 18 or over 71 * Female patient in pregnancy or breast feeding * Not suitable to regular follow up

Locations (1)

Dept. of ophthalmology, Kyung Hee University Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

The change in ETDRS visual acuity letter scores from baseline. The change in the 1-mm central retinal thickness as measured by OCT from baseline.

Time frame: every 4 weeks (up to 52 weeks)

Secondary Outcomes

The intraretinal structure changes in OCT. Progression of avascular area by FA. Number of additional treatments. Intraocular safety (endophthalmitis, uveitis, increase in intraocular pressure, etc).

Time frame: every 4 weeks (up to 52 weeks)

Data from ClinicalTrials.gov

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