An Extension Study to Evaluate Safety and Tolerability of Ranibizumab in Macular Edema Secondary to Retinal Vein Occlusion (Cohort 2)

NCT01442064 | Completed Results

• 1 other identifier: FVF3426g (Cohort 2)
• Study Type: interventional
• Target: 608
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an open-label, multicenter, extension study of intravitreally administered ranibizumab in two cohorts. The first cohort (reported separately under FVF3426g, NCT00379795) enrolled subjects 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 (reported here) enrolled subjects 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)). Patients were enrolled within 14 days of completion of the previous study.

Conditions

Macular Edema; Retinal Vein Occlusion

Keywords

CNV; Lucentis; AMD; Age-related macular degeneration; RVO; Macular edema secondary to retinal vein occlusion

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Ocular Adverse Events in the Study Eye

  Number of participants with: any ocular adverse events, ocular adverse events causing treatment discontinuation, ocular serious adverse events, intraocular inflammation and cataracts that occurred in the study 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.

  Up to 24 months

• Number of Participants With Non-ocular Adverse Events

  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.

  Up to 24 months

Secondary Outcomes (3)

• Change From Baseline in the Best Corrected Visual Acuity (BCVA)

  Baseline (Day 0 of extension study), Months 6, 12, 18, and 24

• Change From Baseline in Central Foveal Thickness at Month 6 and Month 12

  Baseline (Day 0 of extension study), Months 6 and 12

• Change From Baseline in Visual Function Composite Score, as Measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25)

  Baseline (Day 0 of extension study), Months 12 and 24

Study Arms (1)

Ranibizumab 0.5 mg

EXPERIMENTAL

Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) for 24 months.

Drug: Ranibizumab 0.5 mg

Interventions

Ranibizumab 0.5 mg DRUG

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).

Also known as: Lucentis

Ranibizumab 0.5 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form
• The 6-month treatment and 6-month observation phases (12 months total) of a Genentech-sponsored ranibizumab study for RVO (FVF4165g or FVF4166g)
• Expectation by the investigator that the subject may potentially benefit from intravitreal anti-vascular endothelial growth factor (VEGF) treatment

You may not qualify if:

• History of intraocular surgery (including cataract extraction, scleral buckle, etc.) within 1 month prior to Day 0 of this extension study
• Concurrent use of systemic anti-VEGF agents
• Use of RVO treatments not approved by the Food and Drug Administration (FDA) in the study eye
• Use of intravitreal bevacizumab in the study eye and/or fellow eye
• Macular edema in the study eye due to other causes than RVO such as diabetes
• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Conditions

Macular Edema; Retinal Vein Occlusion; Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Genentech
• Organization: Genentech

ctg-post-d@gene.com

Study Officials

• Phillip Lai, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2011
• First Posted: September 28, 2011
• Study Start: July 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: January 10, 2012
• Results First Posted: January 10, 2012

Record last verified: 2011-12