Clinical trial NCT01442064: An Extension Study to Evaluate Safety and Tolerability of Ranibizumab in Macular Edema Secondary to Retinal Vein Occlusion (Cohort 2)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Edema
Retinal Vein Occlusion
Keywords: CNV
Lucentis
AMD
Age-related macular degeneration
RVO
Macular edema secondary to retinal vein occlusion
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2011-09-28
Enrollment: 608
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Number of Participants With Ocular Adverse Events in the Study Eye
timeFrame: Up to 24 months
measure: Number of Participants With Non-ocular Adverse Events
timeFrame: Up to 24 months
Secondary outcomes:
measure: Change From Baseline in the Best Corrected Visual Acuity (BCVA)
timeFrame: Baseline (Day 0 of extension study), Months 6, 12, 18, and 24
measure: Change From Baseline in Central Foveal Thickness at Month 6 and Month 12
timeFrame: Baseline (Day 0 of extension study), Months 6 and 12
measure: Change From Baseline in Visual Function Composite Score, as Measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25)
timeFrame: Baseline (Day 0 of extension study), Months 12 and 24
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Phillip Lai, M.D.
role: STUDY_DIRECTOR
References: