Extension Study of rhuFab V2 in Subjects With Neovascular Age-Related Macular Degeneration (AMD)

NCT00095433 | Completed Phase 3

• 1 other identifier: FVF2508g
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Phase III, open-label, multicenter extension study of intravitreally administered ranibizumab in subjects with primary or recurrent subfoveal choroidal neovascularization (CNV) secondary to AMD who have completed the treatment phase of a Genentech sponsored Phase I or Phase I/II ranibizumab protocol (FVF1770g, FVF2128g, or FVF2425g).

Conditions

Macular Degeneration

Keywords

AMD; Neovascular age-related macular degeneration

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 and authorization of use and disclosure of protected health information
• Age \>=50 years
• Completion of the treatment phase of a Genentech sponsored Phase I or I/II ranibizumab protocol (FVF1770g, FVF2128g, or FVF2425g)

You may not qualify if:

• CNV in either eye due to other causes such as ocular histoplasmosis, trauma, or pathologic myopia
• Active intraocular inflammation (grade trace or above) in the study eye
• Current vitreous hemorrhage in the study eye
• Subretinal hemorrhage in the study eye that involves the fovea, if the size of the hemorrhage is either \>=50% of the total lesion area or \>=1 DA in size
• Intraocular surgery (including cataract surgery) in the study eye within 1 month preceding Week 0
• Uncontrolled glaucoma in the study eye (defined as intraocular pressure \>=30 mmHg despite treatment with anti-glaucoma medication)
• Premenopausal women not using adequate contraception
• Laser photocoagulation (subfoveal, juxtafoveal, or extrafoveal) in the study eye within 30 days preceding Week 0
• Prior treatment with external-beam radiation therapy or transpupillary thermotherapy (TTT) in the study eye
• Previous treatment with verteporfin in the study eye within 30 days preceding Week 0
• Treatment with verteporfin in the non-study eye within 7 days preceding Week 0
• History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye
• Previous participation in a clinical trial (for either eye) involving antiangiogenic drugs other than ranibizumab (e.g., pegaptanib, anecortave acetate, protein kinase C inhibitors, etc.)
• Previous participation in any studies of investigational drugs within 1 month preceding Week 0 (excluding vitamins and minerals studies)
• Discontinuation from a ranibizumab study due to an adverse event judged by the investigator to be possibly or probably related to ranibizumab

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 4, 2004
• First Posted: November 5, 2004
• Study Start: September 1, 2002
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: March 26, 2014

Record last verified: 2014-03