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

March 25, 2014 updated by: Genentech, Inc.

An Extension Study to Evaluate the Safety and Tolerability of Multiple-Dose Intravitreal Injections of rhuFab V2 in Subjects With Neovascular Age-Related Macular Degeneration Who Have Completed the Treatment Phase of a Genentech-Sponsored Phase I or Phase I/II rhuFab V2 Study

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

100

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • 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 from treatment complications
  • Inability to comply with study or follow up procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

November 4, 2004

First Submitted That Met QC Criteria

November 4, 2004

First Posted (Estimate)

November 5, 2004

Study Record Updates

Last Update Posted (Estimate)

March 26, 2014

Last Update Submitted That Met QC Criteria

March 25, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FVF2508g

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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