Intravitreal Ranibizumab 0.5MG, or 1.0mg for RVO With Macular Edema Previously Receiving Bevacizumab (RAVEN)

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Hanscom, Thomas, M.D.
ClinicalTrials.gov Identifier:
NCT01471691
First received: November 9, 2011
Last updated: March 7, 2014
Last verified: March 2014

November 9, 2011
March 7, 2014
November 2011
February 2014   (final data collection date for primary outcome measure)
Mean change from baseline BCVA [ Time Frame: month 6 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01471691 on ClinicalTrials.gov Archive Site
  • mean change from baseline in center point thickness [ Time Frame: months 1-12 ] [ Designated as safety issue: No ]
  • Change in mean best corrected visual acuity from baseline [ Time Frame: months 1-12 ] [ Designated as safety issue: No ]
  • Percentage of patients with CFT less than 300um [ Time Frame: Month 6 and 12 ] [ Designated as safety issue: No ]
  • Excess foveal thickness [ Time Frame: Month 6 and 12 ] [ Designated as safety issue: No ]
  • total number of ranibizumab injections [ Time Frame: month 12 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Intravitreal Ranibizumab 0.5MG, or 1.0mg for RVO With Macular Edema Previously Receiving Bevacizumab
Phase I/II, Open-label, Study of Intravitreal RAnibizumab 0.5MG, or High Dose 1.0mg for Retinal Vein Occlusions With rEfractory Macular Edema Previously Receiving iNtravitreal Bevacizumab (RAVEN)

This study examines two doses of Ranibizumab (0.5mg and 1.0mg) for the treatment of macular edema secondary to retinal vein occlusion in patients that have previously failed treatment with other macular edema treatments including bevacizumab.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Branch Retinal Vein Occlusion
  • Central Retinal Vein Occlusion
  • Macular Edema
  • Drug: ranibizumab 0.5mg
    Standard dose
    Other Name: Lucentis
  • Drug: ranibizumab 1.0mg
    High dose
    Other Name: Lucentis
  • Experimental: intravitreal ranibizumab 0.5mg
    Intervention: Drug: ranibizumab 0.5mg
  • Experimental: intravitreal ranibizumab 1.0mg
    Intervention: Drug: ranibizumab 1.0mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
February 2014
February 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age > 18 years
  • CRVO or BRVO diagnosis
  • For CRVO, clinical evidence of perfused central retinal vein occlusion. A CRVO is defined as an eye that has retinal hemorrhages and a dilated retinal venous system in all 4 quadrants. Other evidence of a CRVO may include telangiectatic capillary bed and collateral vessels at the optic nerve head.
  • Central macular edema present on clinical examination and OCT testing with a central point thickness and/or central 1mm subfield thickness > 300 microns after at least 3 months of bevacizumab or steroid therapy.
  • Visual acuity score greater than or equal to 19 letters (20/400) and less than or equal to 73 letters (20/40) by the ETDRS visual acuity protocol.
  • Patients must demonstrate that they are no longer improving on bevacizumab or intravitreal steroid therapy (i.e. no improvement in acuity in 2 consecutive visits)
  • BRVO patients treated with grid laser must show residual edema three months following latest laser treatment
  • Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography

Exclusion Criteria:

  • Pregnancy (positive pregnancy test) or known to be pregnant; also pre-menopausal women not using adequate contraception.
  • Participation in another ocular investigation or trial simultaneously
  • Any condition that, in the opinion of the investigator, would preclude participation in the study (e.g. chronic alcoholism, drug abuse)
  • Significant diabetic retinopathy (greater than moderate NPDR) or macular edema associated with diabetic retinopathy
  • An eye that, in the investigator's opinion, has no chance of improving in visual acuity following resolution of macular edema (e.g. presence of subretinal fibrosis or geographic atrophy or severe epiretinal membrane)
  • Presence of another ocular condition that may affect the visual acuity or macular edema during the course of the study (e.g. AMD, uveitis, Irvine-Gas)
  • Evidence of neovascularization of the iris or retina (presence of ischemic CRVO/BRVO)
  • Evidence of central atrophy or fibrosis in the study eye
  • Presence of substantial cataract, one that might decrease the vision by 3 or more lines of vision at sometime during the study.
  • History of grid/focal laser or panretinal laser in the study eye in the previous three months
  • History of vitreous surgery in the study eye
  • History of use of intravitreal, peribulbar, or retrobulbar steroids within three months of the study.
  • History of cataract surgery within 6 months of enrollment.
  • History of YAG capsulotomy within 2 months of the surgery.
  • Visual acuity <20/400 in the fellow eye
  • Uncontrolled glaucoma (pressure >30) despite treatment with glaucoma medications.
  • History of cerebral vascular accident or myocardial infarction within 3 months prior to Day 0.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01471691
ML27847
No
Hanscom, Thomas, M.D.
Hanscom, Thomas, M.D.
Genentech, Inc.
Principal Investigator: Thomas O'Hearn, MD Thomas Hanscom AMC
Hanscom, Thomas, M.D.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP