Clinical trial NCT00379795: 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
Official title: An Open-Label, Multicenter Extension Study to Evaluate the Safety and Tolerability of Ranibizumab in Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD) or Macular Edema Secondary to Retinal Vein Occlusion (RVO) Who Have Completed a Genentech-Sponsored Ranibizumab Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Choroidal Neovascularization, Age-related Macular Degeneration
Keywords: CNV
Lucentis
AMD
Age-related macular degeneration
RVO
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2006-09-22
Enrollment: 853
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Number of Participants With Ocular Adverse Events
timeFrame: 36 months
measure: Number of Participants With Non-ocular Adverse Events
timeFrame: 36 months
measure: Number of Participants With Positive Serum Antibodies to Ranibizumab at Month 12 and Month 24
timeFrame: Month 12 and 24
Secondary outcomes:
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters
timeFrame: Extension study baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24
measure: Change From Baseline in Best Corrected Visual Acuity at a Starting Test Distance of 4 Meters
timeFrame: Extension study baseline, Months 12 and 24
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Lisa Tuomi, M.D.
role: STUDY_DIRECTOR
References: