N/A
N=853
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
Choroidal Neovascularization, Age-related Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT00379795 ↗Enrolled (actual)
853
Serious AEs
38.7%
Results posted
Jan 2012
Primary outcome: Primary: Number of Participants With Ocular Adverse Events — 418; 56; 96; 59 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ranibizumab 0.5 mg (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Genentech, Inc.
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Ocular Adverse Events |
418; 56; 96; 59; 46; 2 | — |
| PRIMARY Number of Participants With Non-ocular Adverse Events |
427; 61; 92; 58; 169; 21 | — |
| PRIMARY Number of Participants With Positive Serum Antibodies to Ranibizumab at Month 12 and Month 24 |
10; 0; 1; 0; 9; 0 | — |
| SECONDARY Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters |
-2.9; -2.9; 0.1; -2.7; -3.4; -1.6 | — |
| SECONDARY Change From Baseline in Best Corrected Visual Acuity at a Starting Test Distance of 4 Meters |
-5.4; -1.3; -3.2; -4.4; -7.5; -0.8 | — |
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 Neovascularization (CNV) secondary to Age-Related Macular Degeneration (AMD) who completed the treatment phase of a Genentech sponsored study (FVF2598g (NCT00056836), FVF2587g (NCT00061594), or FVF2428g (NCT00056823)). The second cohort enrolled patients with macular edema secondary to Retinal Vein Occlusion (RVO) who completed the 6-month treatment and 6-month observation phases (12 months total) of a Genentech sponsored study (FVF4165g (NCT00486018) or FVF4166g (NCT00485836)). The results of the second cohort are reported separately (NCT01442064). The first cohort of this study enrolled two subsets of patients: ranibizumab experienced and ranibizumab-naive. Patients were enrolled within 14 days of completion of the 24 month treatment phase of the previous study.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00379795). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.