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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00379795
First received: September 21, 2006
Last updated: January 30, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Choroidal Neovascularization, Age-related Macular Degeneration
Drug: Ranibizumab 0.5 mg

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Number of Participants With Ocular Adverse Events [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

    Number of participants with ocular adverse events in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation, endophthalmitis and intraocular inflammation that occurred in the study eye (the eye that received all study drug injections) and the fellow eye (other eye).

    Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded.


  • Number of Participants With Non-ocular Adverse Events [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

    Number of participants with non-ocular adverse events (not occurring in the eye) in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation and death.

    Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded.

    Additional information about adverse events can be found in the adverse events section.


  • Number of Participants With Positive Serum Antibodies to Ranibizumab at Month 12 and Month 24 [ Time Frame: Month 12 and 24 ] [ Designated as safety issue: Yes ]
    Serum samples for the evaluation of antibodies to Ranibizumab were collected at Month 12 and Month 24 and were sent to a reference laboratory for analysis. If an injection of Ranibizumab was required at the visit, the samples were collected prior to the injection.


Secondary Outcome Measures:
  • Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters [ Time Frame: Extension study baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24 ] [ Designated as safety issue: No ]
    Change from baseline in Best corrected visual acuity (BCVA) was assessed by the number of letters a patient could read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart at a starting test distance of 2 meters. An increase in the number of letters read indicates improvement in visual acuity.

  • Change From Baseline in Best Corrected Visual Acuity at a Starting Test Distance of 4 Meters [ Time Frame: Extension study baseline, Months 12 and 24 ] [ Designated as safety issue: No ]
    Change from baseline in Best corrected visual acuity (BCVA) was assessed by the number of letters a patient could read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart at a starting test distance of 4 meters. An increase in the number of letters read indicates improvement in visual acuity.


Enrollment: 853
Study Start Date: April 2005
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranibizumad 0.5 mg
Ranibizumab 0.5 mg intravitreal injection 0.5 mg in the study eye on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment.
Drug: Ranibizumab 0.5 mg
Ranibizumab intravitreal injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year)

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379795

Sponsors and Collaborators
Genentech
Investigators
Study Director: Lisa Tuomi, M.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00379795     History of Changes
Other Study ID Numbers: FVF3426g (Cohort 1)
Study First Received: September 21, 2006
Results First Received: April 1, 2011
Last Updated: January 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
CNV
Lucentis
AMD
Age-related macular degeneration
RVO

Additional relevant MeSH terms:
Macular Degeneration
Macular Edema
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on September 18, 2014