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

This study has been completed.
Sponsor:
Collaborator:
Genentech
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
  Purpose

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.


Condition Intervention Phase
Branch Retinal Vein Occlusion
Central Retinal Vein Occlusion
Macular Edema
Drug: ranibizumab 0.5mg
Drug: ranibizumab 1.0mg
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Hanscom, Thomas, M.D.:

Primary Outcome Measures:
  • Mean change from baseline BCVA [ Time Frame: month 6 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 14
Study Start Date: November 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intravitreal ranibizumab 0.5mg Drug: ranibizumab 0.5mg
Standard dose
Other Name: Lucentis
Experimental: intravitreal ranibizumab 1.0mg Drug: ranibizumab 1.0mg
High dose
Other Name: Lucentis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01471691

Locations
United States, California
South Coast Retina
Huntington Beach, California, United States, 92647
South Coast Retina
Long Beach, California, United States, 90807
Thomas Hanscom AMC
Santa Monica, California, United States, 90404
South Coast Retina
Torrance, California, United States, 90505
Sponsors and Collaborators
Hanscom, Thomas, M.D.
Genentech
Investigators
Principal Investigator: Thomas O'Hearn, MD Thomas Hanscom AMC
  More Information

No publications provided

Responsible Party: Hanscom, Thomas, M.D.
ClinicalTrials.gov Identifier: NCT01471691     History of Changes
Other Study ID Numbers: ML27847
Study First Received: November 9, 2011
Last Updated: March 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Edema
Macular Edema
Retinal Vein Occlusion
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2014