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CompletedNCT00095433Updated Mar 26, 2014

Extension Study of rhuFab V2 in Subjects With Neovascular Age-Related Macular Degeneration (AMD)

A Phase 3 interventional study of rhuFab V2 (ranibizumab) in Macular Degeneration, sponsored by Genentech, Inc.. Completed. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2014-03-26.

Sponsored by Genentech, Inc. (part of Hoffmann-La Roche) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
100
Ages
50 Years and older
Sex
All
01

Study 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 (FVF1770g, FVF2128g, or FVF2425g).

02

Conditions studied

  • Macular Degeneration

Keywords

  • AMD
  • Neovascular age-related macular degeneration
03

In context

Macular Degeneration

1,490 studies on the registry are indexed under Macular Degeneration; 208 are open to participants now.

This study's enrollment of 100 is above the median of 50 across 993 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Genentech, Inc. is the lead sponsor of 517 studies on the registry; 22 are open to participants now.

Of its 95 completed or terminated interventional studies of FDA-regulated products, 52 (55%) have results posted.

First submitted after Genentech, Inc. became part of Hoffmann-La Roche.

Browse Genentech, Inc. studies →All Hoffmann-La Roche studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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)
  • 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Masking
None (open label)
Enrollment
100 participants

Interventions

06

Study locations

No study locations are listed for this record.

07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2002, a primary completion of Aug 2006 and a completion of Aug 2006. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 4, 2004
First posted
Nov 5, 2004
Start
Sep 2002
Primary completionActual
Aug 2006
CompletionActual
Aug 2006
Last update
Mar 26, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 26, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00095433
Lead sponsor
Genentech, Inc.
First posted
Nov 5, 2004
Start date
Sep 2002
Primary completion
Aug 2006
Completion
Aug 2006
Last update
Mar 26, 2014
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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