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 - Full Text View

Sponsored by:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00379795

Purpose

This is an open-label, multicenter, extension study of intravitreally administered ranibizumab in subjects with primary or recurrent CNV secondary to AMD who have completed the treatment phase of a Genentech sponsored study (FVF2598g, FVF2587g, or FVF2428g) or subjects with macular edema secondary to RVO who have completed the 6-month treatment and 6-month observation phases (12 months total) of a Genentech sponsored study (FVF4165g or FVF4166g). The study will enroll two subsets of subjects: ranibizumab experienced and ranibizumab-naive. Subjects should be enrolled within 14 days of completion of the 24 month treatment phase of the previous study.

Condition	Intervention	Phase
Macular Edema	Drug: ranibizumab	Phase III

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Edema Macular Degeneration

Drug Information available for: Ranibizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment
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

Further study details as provided by Genentech:

Primary Outcome Measures:

Incidence and severity of ocular adverse events, as identified by eye examination [ Time Frame: Length of study ] [ Designated as safety issue: No ]
Incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs [ Time Frame: Length of study ] [ Designated as safety issue: No ]
Incidence of positive serum antibodies to ranibizumab [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 2 meters [ Time Frame: Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36 ] [ Designated as safety issue: No ]
BCVA, as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters [ Time Frame: Months 12, 24, and 36 ] [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	September 2005
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: ranibizumab Intravitreal repeating dose

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Completion of the treatment phase (through Month 24) of a Genentech-sponsored ranibizumab study for AMD (FVF2598g, FVF2587g, or FVF2428g) (Cohort

1) or the 6-month treatment and 6-month observation phases (12 months total) of a Genentech-sponsored ranibizumab study for RVO (FVF4165g or FVF4166g) (Cohort 2)
Expectation by the investigator that the subject may potentially benefit from intravitreal anti-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-VEGF agents
Use of AMD treatments not approved by the FDA
Use of intravitreal Avastin(R) (bevacizumab) in the study eye and/or fellow eye
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
CNV in either eye due to other causes than AMD, such as ocular histoplasmosis, trauma, or pathologic myopia for Cohort 1
Macular edema in the study eye due to other causes than RVO such as diabetes for Cohort 2
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

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

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Lanita Scott, M.D.

Genentech

More Information

No publications provided

Responsible Party:	Genentech, Inc. ( Clinical Trials Posting Group )
Study ID Numbers:	FVF3426g
Study First Received:	September 21, 2006
Last Updated:	September 27, 2008
ClinicalTrials.gov Identifier:	NCT00379795 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

CNV
Lucentis
AMD
Age-related macular degeneration
RVO

Study placed in the following topic categories:

Eye Diseases
Choroid Diseases
Macular Degeneration
Edema
Retinal Degeneration
Choroidal Neovascularization
Macular Edema

Signs and Symptoms
Retinal Vein Occlusion
Metaplasia
Neoplasm Metastasis
Neovascularization, Pathologic
Retinal Diseases

Additional relevant MeSH terms:

Uveal Diseases
Eye Diseases
Choroid Diseases
Edema
Macular Degeneration
Retinal Degeneration
Choroidal Neovascularization
Macular Edema

Signs and Symptoms
Neoplastic Processes
Neoplasms
Pathologic Processes
Metaplasia
Neoplasm Metastasis
Neovascularization, Pathologic
Retinal Diseases

ClinicalTrials.gov processed this record on May 07, 2009