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OpenTrials
Completed

NCT Number: NCT00095433

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

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).

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rhuFab V2 (ranibizumab)

Drug

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
Nov 5, 2004
Registry last updated
Mar 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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