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

An Open-label, Nonrandomized, Phase IIIb, Single Dose Study to Evaluated the Changes in Optical Coherence Tomography (OCT) and Fluorescein Angiography (FA) After Intravitreal Injection of Lucentis® in Patients With Macular Edema Secondary to Retinal Vein Occlusion (RVO)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00942864

Enrollment

Registered

2009-07-21

Start date

2008-12-31

Completion date

2009-12-31

Last updated

2016-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Edema, Retinal Vein Occlusion

Brief summary

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).

Interventions

DRUGranibizumab

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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.	every 4 weeks (up to 52 weeks)

Secondary

Measure	Time frame
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).	every 4 weeks (up to 52 weeks)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026