Status:
COMPLETED
An Extension Study to Evaluate the Safety and Tolerability of Ranibizumab in Subjects With Choroidal Neovascularization Secondary to AMD or Macular Edema Secondary to RVO
Lead Sponsor:
Genentech, Inc.
Conditions:
Choroidal Neovascularization, Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
This was an open-label, multicenter, extension study of intravitreally administered ranibizumab in two cohorts. The first cohort (reported here) enrolled patients with primary or recurrent Choroidal N...
Eligibility Criteria
Inclusion
- Signed informed consent form.
- Completion of the treatment phase (through Month 24) of a Genentech-sponsored ranibizumab study for AMD (FVF2598g, FVF2587g, or FVF2428g) (Cohort 1)
- Expectation by the investigator that the subject may potentially benefit from intravitreal anti-vascular endothelial growth factor (VEGF) treatment
Exclusion
- Previous subfoveal focal laser photocoagulation in the study eye
- Previous pegaptanib sodium injection in the study eye
- Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0 of this extension study
- History of submacular surgery or other surgical intervention for AMD in the study eye
- History of glaucoma filtering surgery in the study eye
- History of corneal transplant in the study eye
- Concurrent use of systemic anti-EGF agents
- Use of AMD treatments not approved by the FDA
- Use of intravitreal Avastin(R) (bevacizumab) in the study eye and/or fellow eye
- CNV in either eye due to other causes than AMD, such as ocular histoplasmosis, trauma, or pathologic myopia for Cohort 1
- 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
- Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 30 mmHg despite treatment with antiglaucoma medication)
- Pregnancy or lactation
- 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 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
- Inability to comply with study or follow-up procedures
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
853 Patients enrolled
Trial Details
Trial ID
NCT00379795
Start Date
April 1 2005
End Date
September 1 2008
Last Update
May 11 2017
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