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

NCT00251459 | Completed Phase 3

• 1 other identifier: FVF3689g
• Study Type: interventional
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Choroidal Neovascularization; Age-related Macular Degeneration

Keywords

SAILOR; CNV; AMD; CNV secondary to AMD

Outcome Measures

Primary Outcomes (2)

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

• 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)

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

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

• Mean time to retreatment following the initial three monthly loading doses

• Mean total number of injections through Month 12.

Interventions

rhuFab V2 (ranibizumab) DRUG

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Related Publications (1)

• 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.

  PMID: 19643495 RESULT

MeSH Terms

Conditions

Choroidal Neovascularization; Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Retinal Degeneration; Retinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Tsontcho Ianchulev, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 8, 2005
• First Posted: November 10, 2005
• Study Start: November 1, 2005
• Study Completion: September 1, 2007
• Last Updated: March 10, 2014

Record last verified: 2014-03