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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00251459
Recruitment Status : Completed
First Posted : November 10, 2005
Last Update Posted : March 10, 2014
Information provided by:
Genentech, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Choroidal Neovascularization Age-related Macular Degeneration Drug: rhuFab V2 (ranibizumab) Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 5000 participants
Primary Purpose: Treatment
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)
Study Start Date : November 2005
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00251459

Sponsors and Collaborators
Genentech, Inc.
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Study Director: Tsontcho Ianchulev, M.D. Genentech, Inc.
Publications of Results:
Layout table for additonal information Identifier: NCT00251459    
Obsolete Identifiers: NCT00299078
Other Study ID Numbers: FVF3689g
First Posted: November 10, 2005    Key Record Dates
Last Update Posted: March 10, 2014
Last Verified: March 2014
Keywords provided by Genentech, Inc.:
CNV secondary to AMD
Additional relevant MeSH terms:
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Macular Degeneration
Choroidal Neovascularization
Neovascularization, Pathologic
Pathologic Processes
Retinal Degeneration
Retinal Diseases
Eye Diseases
Choroid Diseases
Uveal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents