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

Novartis

Status and phase: Completed; Phase 3

Conditions: Macular Edema; Retinal Vein Occlusion

Treatments: Drug: ranibizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00942864

CRFB002AKR07

Details and patient eligibility

About

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).

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)