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

Macular Edema Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00942864
• Other study ID #: CRFB002AKR07
• Status: Completed
• Phase: Phase 3
• First received: July 17, 2009
• Last updated: September 27, 2016
• Start date: December 2008
• Est. completion date: December 2009

Study information

• Verified date: September 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Edema
• Macular Edema
• Retinal Vein Occlusion

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Dept. of ophthalmology, Kyung Hee University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Korea Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	Yes