An Extension Study to Evaluate Safety and Tolerability of Ranibizumab in Macular Edema Secondary to Retinal Vein Occlusion (Cohort 2)

Genentech

Status: Completed

Conditions: Macular Edema; Retinal Vein Occlusion

Treatments: Drug: Ranibizumab 0.5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01442064

FVF3426g (Cohort 2)

Details and patient eligibility

About

This is an open-label, multicenter, extension study of intravitreally administered ranibizumab in two cohorts. The first cohort (reported separately under FVF3426g, NCT00379795) enrolled subjects with primary or recurrent Choroidal Neovascularization (CNV) secondary to Age-Related Macular Degeneration (AMD) who completed the treatment phase of a Genentech sponsored study (FVF2598g (NCT00056836), FVF2587g (NCT00061594), or FVF2428g (NCT00056823)). The second cohort (reported here) enrolled subjects with macular edema secondary to Retinal Vein Occlusion (RVO) who completed the 6-month treatment and 6-month observation phases (12 months total) of a Genentech sponsored study (FVF4165g (NCT00486018) or FVF4166g (NCT00485836)). Patients were enrolled within 14 days of completion of the previous study.

Enrollment: 608 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent form
• The 6-month treatment and 6-month observation phases (12 months total) of a Genentech-sponsored ranibizumab study for RVO (FVF4165g or FVF4166g)
• Expectation by the investigator that the subject may potentially benefit from intravitreal anti-vascular endothelial growth factor (VEGF) treatment

Exclusion criteria

• History of intraocular surgery (including cataract extraction, scleral buckle, etc.) within 1 month prior to Day 0 of this extension study
• Concurrent use of systemic anti-VEGF agents
• Use of RVO treatments not approved by the Food and Drug Administration (FDA) in the study eye
• Use of intravitreal bevacizumab in the study eye and/or fellow eye
• Macular edema in the study eye due to other causes than RVO such as diabetes
• History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
• History of idiopathic or autoimmune-associated uveitis in either eye
• Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 30 mmHg despite treatment with antiglaucoma medication)
• Pregnancy or lactation
• Premenopausal women not using adequate contraception
• History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications
• Current treatment for active systemic infection
• Inability to comply with study or follow-up procedures

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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608 participants in 1 patient group

Ranibizumab 0.5 mg

Experimental group

Description:

Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) for 24 months.

Treatment:

Drug: Ranibizumab 0.5 mg