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

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.

Study Overview

• Status: Completed
• Conditions: Central Retinal Vein Occlusion; Macular Edema; Branch Retinal Vein Occlusion
• Intervention / Treatment: Drug: ranibizumab 0.5mg; Drug: ranibizumab 1.0mg

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Huntington Beach, California, United States, 92647
      • South Coast Retina
    • Long Beach, California, United States, 90807
      • South Coast Retina
    • Santa Monica, California, United States, 90404
      • Thomas Hanscom AMC
    • Torrance, California, United States, 90505
      • South Coast Retina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intravitreal ranibizumab 0.5mg	Drug: ranibizumab 0.5mg; Standard dose; Other Names: Lucentis
Experimental: intravitreal ranibizumab 1.0mg	Drug: ranibizumab 1.0mg; High dose; Other Names: Lucentis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline BCVA	Vision was measured using a standard ETDRS chart at baseline and each subsequent monthly visit.	Baseline to month 6

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean Change From Baseline in Center Point Thickness	months 1-12
Change in Mean Best Corrected Visual Acuity From Baseline	months 1-12
Percentage of Patients With CFT Less Than 300um	Month 6 and 12
Excess Foveal Thickness	Month 6 and 12
Total Number of Ranibizumab Injections	month 12

Collaborators and Investigators

• Sponsor: Hanscom, Thomas, M.D.
• Collaborators: Genentech, Inc.
• Investigators: Principal Investigator: Thomas O'Hearn, MD, Thomas Hanscom AMC

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: November 9, 2011
• First Submitted That Met QC Criteria: November 10, 2011
• First Posted (Estimate): November 16, 2011

Study Record Updates

• Last Update Posted (Estimate): April 29, 2015
• Last Update Submitted That Met QC Criteria: April 10, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Retinal Degeneration; Retinal Diseases; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Macular Degeneration; Macular Edema; Retinal Vein Occlusion; Edema; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab
• Other Study ID Numbers: ML27847