An Extension Study to Evaluate Safety and Tolerability of Ranibizumab in Macular Edema Secondary to Retinal Vein Occlusion (Cohort 2)
Information source: Genentech, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Macular Edema; Retinal Vein Occlusion
Intervention: Ranibizumab 0.5 mg (Drug)
Phase: N/A
Status: Completed
Sponsored by: Genentech, Inc. Official(s) and/or principal investigator(s): Phillip Lai, M.D., Study Director, Affiliation: Genentech, Inc.
Summary
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.
Clinical Details
Official title: An Open-Label, Multicenter Extension Study to Evaluate the Safety and Tolerability of Ranibizumab in Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD) or Macular Edema Secondary to Retinal Vein Occlusion (RVO) Who Have Completed a Genentech-Sponsored Ranibizumab Study
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of Participants With Ocular Adverse Events in the Study EyeNumber of Participants With Non-ocular Adverse Events
Secondary outcome: Change From Baseline in the Best Corrected Visual Acuity (BCVA)Change From Baseline in Central Foveal Thickness at Month 6 and Month 12 Change From Baseline in Visual Function Composite Score, as Measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: July 2008
Last updated: December 5, 2011
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