Macular DegenerationPhase 3NCT00095433
Extension Study of rhuFab V2 in Subjects With Neovascular Age-Related Macular Degeneration (AMD)
A Phase 3 study testing rhuFab V2 (ranibizumab) in people with Macular Degeneration, run by Genentech, Inc..
Trial summary
This is a Phase III, open-label, multicenter extension study of intravitreally administered ranibizumab in subjects with primary or recurrent subfoveal choroidal neovascularization (CNV) secondary to AMD who have completed the treatment phase of a Genentech sponsored Phase I or Phase I/II ranibizumab protocol… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- rhuFab V2 (ranibizumab)
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2002to Aug 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent and authorization of use and disclosure of protected health information
- Age >=50 years
- Completion of the treatment phase of a Genentech sponsored Phase I or I/II ranibizumab protocol (FVF1770g, FVF2128g, or FVF2425g)
Who cannot join
- CNV in either eye due to other causes such as ocular histoplasmosis, trauma, or pathologic myopia
- Active intraocular inflammation (grade trace or above) in the study eye
- Current vitreous hemorrhage in the study eye
- Subretinal hemorrhage in the study eye that involves the fovea, if the size of the hemorrhage is either >=50% of the total lesion area or >=1 DA in size
- Intraocular surgery (including cataract surgery) in the study eye within 1 month preceding Week 0
- Uncontrolled glaucoma in the study eye (defined as intraocular pressure >=30 mmHg despite treatment with anti-glaucoma medication)
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- Premenopausal women not using adequate contraception
- Laser photocoagulation (subfoveal, juxtafoveal, or extrafoveal) in the study eye within 30 days preceding Week 0
- Prior treatment with external-beam radiation therapy or transpupillary thermotherapy (TTT) in the study eye
- Previous treatment with verteporfin in the study eye within 30 days preceding Week 0
- Treatment with verteporfin in the non-study eye within 7 days preceding Week 0
- History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye
- Previous participation in a clinical trial (for either eye) involving antiangiogenic drugs other than ranibizumab (e.g., pegaptanib, anecortave acetate, protein kinase C inhibitors, etc.)
- Previous participation in any studies of investigational drugs within 1 month preceding Week 0 (excluding vitamins and minerals studies)
- Discontinuation from a ranibizumab study due to an adverse event judged by the investigator to be possibly or probably related to ranibizumab
- 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 of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk from treatment complications
- Inability to comply with study or follow up procedures
About this study
Official title: An Extension Study to Evaluate the Safety and Tolerability of Multiple-Dose Intravitreal Injections of rhuFab V2 in Subjects With Neovascular Age-Related Macular Degeneration Who Have Completed the Treatment Phase of a Genentech-Sponsored Phase I or Phase I/II rhuFab V2 Study
This is a Phase III, open-label, multicenter extension study of intravitreally administered ranibizumab in subjects with primary or recurrent subfoveal choroidal neovascularization (CNV) secondary to AMD who have completed the treatment phase of a Genentech sponsored Phase I or Phase I/II ranibizumab protocol (FVF1770g, FVF2128g, or FVF2425g).
- Conditions
- Macular Degeneration
- Being tested
- rhuFab V2 (ranibizumab)
- Keywords
- AMD, Neovascular age-related macular degeneration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhuFab V2 (ranibizumab)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2004 (estimated)
- Study startSep 2002
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00095433
- Sponsor's protocol ID
- FVF2508g
- Status last verified
- Mar 2014
- First submitted
- 4 Nov 2004
- Last updated
- 26 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension Study to Evaluate the Safety and Tolerability of Multiple-Dose Intravitreal Injections of rhuFab V2 in Subjects With Neovascular Age-Related Macular Degeneration Who Have Completed the Treatment Phase of a Genentech-Sponsored Phase I or Phase I/II rhuFab V2 Study
- ClinicalTrials.gov ID
- NCT00095433
- Acronym / sponsor ID
- FVF2508g
- Conditions
- Macular Degeneration
- Keywords
- AMD, Neovascular age-related macular degeneration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2002
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 5 Nov 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase III, open-label, multicenter extension study of intravitreally administered ranibizumab in subjects with primary or recurrent subfoveal choroidal neovascularization (CNV) secondary to AMD who have completed the treatment phase of a Genentech sponsored Phase I or Phase I/II ranibizumab protocol (FVF1770g, FVF2128g, or FVF2425g).
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed informed consent and authorization of use and disclosure of protected health information
- Age >=50 years
- Completion of the treatment phase of a Genentech sponsored Phase I or I/II ranibizumab protocol (FVF1770g, FVF2128g, or FVF2425g)
Key exclusion criteria (17 listed)
- CNV in either eye due to other causes such as ocular histoplasmosis, trauma, or pathologic myopia
- Active intraocular inflammation (grade trace or above) in the study eye
- Current vitreous hemorrhage in the study eye
- Subretinal hemorrhage in the study eye that involves the fovea, if the size of the hemorrhage is either >=50% of the total lesion area or >=1 DA in size
- Intraocular surgery (including cataract surgery) in the study eye within 1 month preceding Week 0
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rhuFab V2 (ranibizumab) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rhuFab V2 (ranibizumab) in people with Macular Degeneration, run by Genentech, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2014.