A Study of rhuFab V2 (Ranibizumab) in Subjects With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD)

Completed · Phase 3

Conditions studied: Macular Degeneration

In brief

This is a phase III, multicenter, randomized, double masked, sham injection-controlled study of the efficacy and safety of intravitreally administered ranibizumab in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration.

Key facts

Study ID

NCT00090623

Run by

Genentech, Inc.

People needed

180

Starts

2004-08-01

Expected to finish

2007-03-01

Last updated by the study team

2013-06-21

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent
• Age >=50 years
• Active primary or recurrent subfoveal CNV lesions secondary to AMD in the study eye
• Total area of CNV (including both classic and occult components) encompassed within the lesion >= 50% of the total lesion area
• Total lesion area <=12 disc areas in size
• Best corrected visual acuity (BCVA), using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts, of 20/40 to 20/320 (Snellen equivalent) in the study eye

You may not qualify if…

• Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
• Treatment with verteporfin in the nonstudy eye <7 days preceding Day 0
• Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)
• Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye
• Previous subfoveal focal laser photocoagulation in the study eye
• Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0
• History of vitrectomy surgery in the study eye
• History of submacular surgery or other surgical intervention for AMD in the study eye
• Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals)
• Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either >= 50% of the total lesion area or >=1 disc area in size
• Fibrosis or atrophy involving the center of the fovea in the study eye
• 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: (1) Require medical or surgical intervention during the 24-month study period to prevent or treat visual loss that might result from that condition, or (2) If allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of BCVA over the 24-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
• Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
• Aphakia or absence of the posterior capsule in the study eye
• 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 >=30 mmHg despite treatment with antiglaucoma medication)
• History of glaucoma filtering surgery in the study eye
• History of corneal transplant in the study eye

Where it is running

• Trial Information Support Line — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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