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

Macular Edema Clinical Trial

— RAVEN  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01471691
• Other study ID #: ML27847
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 9, 2011
• Last updated: April 10, 2015
• Start date: November 2011
• Est. completion date: February 2014

Study information

• Verified date: April 2015
• Source: Hanscom, Thomas, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Branch Retinal Vein Occlusion
• Central Retinal Vein Occlusion
• Edema
• Macular Edema
• Retinal Vein Occlusion

Intervention

Drug:
• ranibizumab 0.5mg
Standard dose
• ranibizumab 1.0mg
High dose

Locations

Country	Name	City	State
United States	South Coast Retina	Huntington Beach	California
United States	South Coast Retina	Long Beach	California
United States	Thomas Hanscom AMC	Santa Monica	California
United States	South Coast Retina	Torrance	California

Sponsors (2)

Lead Sponsor	Collaborator
Hanscom, Thomas, M.D.	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline BCVA	Vision was measured using a standard ETDRS chart at baseline and each subsequent monthly visit.	Baseline to month 6	No
Secondary	Mean Change From Baseline in Center Point Thickness		months 1-12	No
Secondary	Change in Mean Best Corrected Visual Acuity From Baseline		months 1-12	No
Secondary	Percentage of Patients With CFT Less Than 300um		Month 6 and 12	No
Secondary	Excess Foveal Thickness		Month 6 and 12	No
Secondary	Total Number of Ranibizumab Injections		month 12	No