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

Macular Degeneration Clinical Trial

Official title:

A Phase IIIb, Multicenter, Randomized, Double Masked, Sham Injection-Controlled Study of the Efficacy and Safety of Ranibizumab in Subjects With Subfoveal Choroidal Neovascularization (CNV) With or Without Classic CNV Secondary to Age Related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00090623
• Other study ID #: FVF3192g
• Status: Completed
• Phase: Phase 3
• First received: August 30, 2004
• Last updated: June 19, 2013
• Start date: August 2004
• Est. completion date: March 2007

Study information

• Verified date: June 2013
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Premenopausal women not using adequate contraception

• 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 for treatment complications

• Current treatment for active systemic infection

• History of allergy to fluorescein, not amenable to treatment

• Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality to be analyzed and graded by the central reading center

• Inability to comply with study or follow up procedures

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic

Intervention

Drug:
• rhuFab V2 (ranibizumab)

Locations

Country	Name	City	State
United States	Trial Information Support Line	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Regillo CD, Brown DM, Abraham P, Yue H, Ianchulev T, Schneider S, Shams N. Randomized, double-masked, sham-controlled trial of ranibizumab for neovascular age-related macular degeneration: PIER Study year 1. Am J Ophthalmol. 2008 Feb;145(2):239-248. doi: — View Citation