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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/NCT00379795




Registration number
NCT00379795
Ethics application status
Date submitted
21/09/2006
Date registered
22/09/2006
Date last updated
11/05/2017

Titles & IDs
Public title
An Extension Study to Evaluate the Safety and Tolerability of Ranibizumab in Subjects With Choroidal Neovascularization Secondary to AMD or Macular Edema Secondary to RVO
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 1)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Choroidal Neovascularization, Age-related Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders

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

Experimental: Ranibizumad 0.5 mg - Ranibizumab 0.5 mg intravitreal injection 0.5 mg in the study eye on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment.


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
Timepoint [1] 0 0
36 months
Primary outcome [2] 0 0
Number of Participants With Non-ocular Adverse Events
Timepoint [2] 0 0
36 months
Primary outcome [3] 0 0
Number of Participants With Positive Serum Antibodies to Ranibizumab at Month 12 and Month 24
Timepoint [3] 0 0
Month 12 and 24
Secondary outcome [1] 0 0
Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters
Timepoint [1] 0 0
Extension study baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24
Secondary outcome [2] 0 0
Change From Baseline in Best Corrected Visual Acuity at a Starting Test Distance of 4 Meters
Timepoint [2] 0 0
Extension study baseline, Months 12 and 24

Eligibility
Key inclusion criteria
- Signed informed consent form.

- Completion of the treatment phase (through Month 24) of a Genentech-sponsored
ranibizumab study for AMD (FVF2598g, FVF2587g, or FVF2428g) (Cohort 1)

- Expectation by the investigator that the subject may potentially benefit from
intravitreal anti-vascular endothelial growth factor (VEGF) treatment
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous subfoveal focal laser photocoagulation in the study eye

- Previous pegaptanib sodium injection in the study eye

- Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month
preceding Day 0 of this extension study

- History of submacular surgery or other surgical intervention for AMD in the study eye

- History of glaucoma filtering surgery in the study eye

- History of corneal transplant in the study eye

- Concurrent use of systemic anti-EGF agents

- Use of AMD treatments not approved by the FDA

- Use of intravitreal Avastin(R) (bevacizumab) in the study eye and/or fellow eye

- CNV in either eye due to other causes than AMD, such as ocular histoplasmosis, trauma,
or pathologic myopia for Cohort 1

- 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
1/04/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2008
Sample size
Target
Accrual to date
Final
853
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 was an open-label, multicenter, extension study of intravitreally administered
ranibizumab in two cohorts. The first cohort (reported here) enrolled patients 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 enrolled
patients 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)). The results of the second cohort
are reported separately (NCT01442064). The first cohort of this study enrolled two subsets of
patients: ranibizumab experienced and ranibizumab-naive. Patients were enrolled within 14
days of completion of the 24 month treatment phase of the previous study.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00379795
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
Lisa Tuomi, 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