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Choroidal NeovascularizationPhase 3NCT00251459

A Study to Evaluate Ranibizumab in Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)

A Phase 3 study testing rhuFab V2 (ranibizumab) in people with Choroidal Neovascularization and Age-related Macular Degeneration, run by Genentech, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase IIIb, single-masked, 1-year multicenter study of the safety and tolerability of intravitreally administered ranibizumab in subjects with active subfoveal CNV secondary to AMD. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
rhuFab V2 (ranibizumab)
How many people
5,000 participants
Where
No sites listed yet
Study dates
Nov 2005to Sep 2007
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 Form
  • Age ≥ 50 years
  • Subfoveal CNV secondary to AMD, with evidence of recent disease progression, as defined by any of the following (lesion is eligible if it meets any one of the following criteria): ≥ 5 letters (or ≥ 1 Snellen line) of BCVA lost within 6 months preceding Day 0\; ≥ 10% increase in lesion area, as determined by comparing a FA performed within 1 month preceding Day 0 to a FA performed within 6 months preceding Day 0; Subretinal hemorrhage associated with CNV within 1 month preceding Day 0; Classic CNV comprising > 50% of CNV lesion area
  • BCVA, using ETDRS charts for Cohort 1 and Snellen charts for Cohort 2, of 20/40 to 20/320 (Snellen equivalent) in the study eye

Who cannot join

  • Treatment with verteporfin PDT, pegaptanib sodium, or other AMD therapy in the study eye < 30 days preceding Day 0
  • History of submacular surgery or other surgical intervention for AMD in the study eye
  • Previous participation in any studies of investigational drugs within 30 days preceding Day 0 (excluding vitamins and minerals)
  • Prior participation in a Genentech ranibizumab clinical trial
  • Treatment with intravitreally administered (in either eye) Avastin(R) (bevacizumab) within 30 days preceding Day 0
  • Concurrent use of systemic anti-VEGF agents
Show all 29Show fewer
  • Fibrosis or atrophy involving the center of the fovea in the study eye, in the absence of a new lesion
  • CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
  • Retinal pigment epithelial tear involving the macula in the study eye
  • Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either require medical or surgical intervention during the 12-month study period to prevent or treat visual loss that might result from that condition, or, if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of BCVA over the 12-month study period
  • Active intraocular inflammation (grade trace or above) in the study eye
  • Current vitreous hemorrhage in the study eye
  • 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
  • Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
  • Aphakia or pseudophakia with absence of the posterior capsule (unless it occurred as a result of a yttrium aluminum garnet [YAG] posterior capsulotomy)
  • Spherical equivalent of the refractive error in the study eye demonstrating more than -8 diopters of myopia
  • Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Day 0
  • Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with antiglaucoma medication)
  • Concurrent use of more than one therapy for glaucoma
  • History of glaucoma filtering surgery in the study eye
  • History of corneal transplant in the study eye
  • Premenopausal women not using adequate contraception
  • Pregnancy or lactation
  • 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 a significant active systemic infection
  • Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders
  • History of recurrent significant infections or bacterial infections
  • Inability to comply with study or follow-up procedures

About this study

Official title: A Phase IIIb, Single-Masked, Multicenter, Randomized Study to Evaluate the Safety and Tolerability of Ranibizumab in Naive and Previously Treated Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)

This is a Phase IIIb, single-masked, 1-year multicenter study of the safety and tolerability of intravitreally administered ranibizumab in subjects with active subfoveal CNV secondary to AMD.

Being tested
rhuFab V2 (ranibizumab)
Keywords
SAILOR, CNV, AMD, CNV secondary to AMD
Medical subject headings
Choroidal Neovascularization, 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cohort 1: The primary safety outcome measure is the incidence of SAEs (ocular and non ocular) evaluated through Month 12.

  2. Cohort 2: The primary safety outcome measure is the incidence of SAEs (ocular and non-ocular) and AEs (ocular and non-ocular) evaluated through Month 12.

Secondary outcomes (4)

  1. Incidence of AEs (ocular and non-ocular) evaluated through Month 12

  2. Proportion of subjects who lose at least 15 letters in BCVA at Month 12 compared with baseline

  3. Mean time to retreatment following the initial three monthly loading doses

  4. Mean total number of injections through Month 12.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2005 (estimated)
  2. Study startNov 2005
  3. Study completionSep 2007

Resources

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
Enrolment
5,000 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00251459
Sponsor's protocol ID
FVF3689g
Status last verified
Mar 2014
First submitted
8 Nov 2005
Last updated
10 Mar 2014
Results posted
No

Publications

  • Boyer DS, Heier JS, Brown DM, Francom SF, Ianchulev T, Rubio RG. A Phase IIIb study to evaluate the safety of ranibizumab in subjects with neovascular age-related macular degeneration. Ophthalmology. 2009 Sep;116(9):1731-9. doi: 10.1016/j.ophtha.2009.05.024. Epub 2009 Jul 29.

    PubMed 19643495

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rhuFab V2 (ranibizumab) in people with Choroidal Neovascularization and Age-related 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 4 inclusion and 29 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 10 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.

What does the primary outcome measure?

Cohort 1: The primary safety outcome measure is the incidence of SAEs (ocular and non ocular) evaluated through Month 12.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00251459, which also lists 1 linked publication.

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 10 Mar 2014.

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