Clinical trial NCT01471691: Intravitreal Ranibizumab 0.5MG, or 1.0mg for RVO With Macular Edema Previously Receiving Bevacizumab
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Branch Retinal Vein Occlusion
Central Retinal Vein Occlusion
Macular Edema
Lead sponsor: Hanscom, Thomas, M.D.
Sponsor class: INDIV
Collaborators: name: Genentech, Inc.
First posted: 2011-11-16
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Mean Change From Baseline BCVA
timeFrame: Baseline to month 6
Secondary outcomes:
measure: Mean Change From Baseline in Center Point Thickness
timeFrame: months 1-12
measure: Change in Mean Best Corrected Visual Acuity From Baseline
timeFrame: months 1-12
measure: Percentage of Patients With CFT Less Than 300um
timeFrame: Month 6 and 12
measure: Excess Foveal Thickness
timeFrame: Month 6 and 12
measure: Total Number of Ranibizumab Injections
timeFrame: month 12
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: South Coast Retina
state: California
city: Long Beach
country: United States
facility: South Coast Retina
state: California
city: Santa Monica
country: United States
facility: Thomas Hanscom AMC
state: California
city: Torrance
country: United States
facility: South Coast Retina
state: California
Study officials:
affiliation: Thomas Hanscom AMC
name: Thomas O'Hearn, MD
role: PRINCIPAL_INVESTIGATOR
References: