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

Last updated: March 6, 2014
Sponsor: Genentech, Inc.
Overall Status: Completed

Phase

3

Condition

Myopic Macular Degeneration

Macular Degeneration

Aging

Treatment

N/A

Clinical Study ID

NCT00251459
FVF3689g
  • Ages > 50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed Informed Consent Form

  • Age ≥ 50 years

  • Subfoveal CNV secondary to AMD, with evidence of recent disease progression, asdefined by any of the following (lesion is eligible if it meets any one of thefollowing criteria): ≥ 5 letters (or ≥ 1 Snellen line) of BCVA lost within 6 monthspreceding Day 0; ≥ 10% increase in lesion area, as determined by comparing a FAperformed within 1 month preceding Day 0 to a FA performed within 6 months precedingDay 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

Exclusion Criteria:

  • Treatment with verteporfin PDT, pegaptanib sodium, or other AMD therapy in the studyeye < 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 dayspreceding 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 absenceof a new lesion

  • CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, orpathologic myopia

  • Retinal pigment epithelial tear involving the macula in the study eye

  • Any concurrent intraocular condition in the study eye (e.g., cataract or diabeticretinopathy) that, in the opinion of the investigator, could either require medical orsurgical intervention during the 12-month study period to prevent or treat visual lossthat might result from that condition, or, if allowed to progress untreated, couldlikely 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 thestudy eye

  • History of idiopathic or autoimmune-associated uveitis in either eye

  • Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in eithereye

  • Aphakia or pseudophakia with absence of the posterior capsule (unless it occurred as aresult 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 monthspreceding Day 0

  • Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHgdespite 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, orclinical laboratory finding giving reasonable suspicion of a disease or condition thatcontraindicates the use an investigational drug or that might affect interpretation ofthe results of the study or render the subject at high risk for treatmentcomplications

  • Current treatment for a significant active systemic infection

  • Evidence of significant uncontrolled concomitant diseases such as cardiovasculardisease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinaldisorders

  • History of recurrent significant infections or bacterial infections

  • Inability to comply with study or follow-up procedures

Study Design

Total Participants: 5000
Study Start date:
November 01, 2005
Estimated Completion Date:
September 30, 2007