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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01442064




Registration number
NCT01442064
Ethics application status
Date submitted
26/09/2011
Date registered
28/09/2011
Date last updated
10/01/2012

Titles & IDs
Public title
An Extension Study to Evaluate Safety and Tolerability of Ranibizumab in Macular Edema Secondary to Retinal Vein Occlusion (Cohort 2)
Scientific 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
Secondary ID [1] 0 0
FVF3426g (Cohort 2)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Macular Edema 0 0
Retinal Vein Occlusion 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ranibizumab 0.5 mg

Experimental: Ranibizumab 0.5 mg - 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: Drugs: Ranibizumab 0.5 mg
Ranibizumab intravitreal injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Ocular Adverse Events in the Study Eye
Timepoint [1] 0 0
Up to 24 months
Primary outcome [2] 0 0
Number of Participants With Non-ocular Adverse Events
Timepoint [2] 0 0
Up to 24 months
Secondary outcome [1] 0 0
Change From Baseline in the Best Corrected Visual Acuity (BCVA)
Timepoint [1] 0 0
Baseline (Day 0 of extension study), Months 6, 12, 18, and 24
Secondary outcome [2] 0 0
Change From Baseline in Central Foveal Thickness at Month 6 and Month 12
Timepoint [2] 0 0
Baseline (Day 0 of extension study), Months 6 and 12
Secondary outcome [3] 0 0
Change From Baseline in Visual Function Composite Score, as Measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25)
Timepoint [3] 0 0
Baseline (Day 0 of extension study), Months 12 and 24

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2010
Sample size
Target
Accrual to date
Final
608
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genentech, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01442064
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Phillip Lai, M.D.
Address 0 0
Genentech, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries