Efficacy and Safety of Ranibizumab in Japanese Patients With Retinal Vein Occlusion (RVO in Japan)

Novartis

Status and phase: Completed; Phase 3

Conditions: Retinal Vein Occlusion

Treatments: Drug: ranibizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01377597

CRFB002E2301

Details and patient eligibility

About

The purpose of this study is to provide efficacy and safety data of 3 consecutive monthly intravitreal injections with 0.5 mg ranibizumab in Japanese patients with visual impairment due to macular edema secondary to retinal vein occlusion (BRVO or CRVO) to support the applicability of the phase III study results of BRAVO and CRUISE in this indication, in the Japanese ethnic patients.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Japanese patients diagnosed with visual impairment exclusively due to macular edema secondary to either branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) Diagnosis within 12 months prior to Visit 1
• Best-corrected visual acuity (BCVA):
• CRVO: BCVA score ≥24 and ≤73 letters ETDRS (approx. Snellen equivalent of 20/320 and 20/40) at Visit 1 and 2
• BRVO: BCVA score ≥19 and ≤73 letters ETDRS (approx. Snellen equivalent of 20/400 and 20/40) at Visit 1 and 2

Exclusion criteria

• Pregnant or nursing women
• History of stroke
• Uncontrolled blood pressure
• Active ocular infection or intraocular inflammation in either eye
• Uncontrolled glaucoma in either eye
• Neovascularization of the iris or neovascular glaucoma in either eye
• Prior episode of RVO more than 12 months prior to Visit 1 in the study eye
• Use of any systemic anti-VEGF drugs within 6 months prior to Visit 2
• Prior treatment with any anti-angiogenic drugs within 3 months prior to Visit 2 in either eye
• Prior panretinal laser photocoagulation within 3 months prior to Visit 2 in the study eye
• Prior focal/grid laser photocoagulation within 4 months prior to Visit 2 in the study eye
• Use of intra-/peri-ocular corticosteroids within 3 months prior to Visit 1 in the study eye
• Use of any intra-ocular corticosteroid implants in the study eye

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 1 patient group

ranibizumab intravitreal injection

Experimental group

Treatment:

Drug: ranibizumab