Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, Macular Edema
Conditions
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.
Interventions
Standard dose
DRUGranibizumab 1.0mg
High dose
Sponsors
Genentech, Inc.
Hanscom, Thomas, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline BCVA | Baseline to month 6 | Vision was measured using a standard ETDRS chart at baseline and each subsequent monthly visit. |
Secondary
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intravitreal Ranibizumab 0.5mg ranibizumab 0.5mg: Standard dose | 8 |
| Intravitreal Ranibizumab 1.0mg ranibizumab 1.0mg: High dose | 6 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 0 | 1 |
Baseline characteristics
| Characteristic | Intravitreal Ranibizumab 0.5mg | Intravitreal Ranibizumab 1.0mg | Total |
|---|---|---|---|
| Age, Continuous | 73 years STANDARD_DEVIATION 5 | 78 years STANDARD_DEVIATION 5 | 75 years STANDARD_DEVIATION 5 |
| Region of Enrollment United States | 8 participants | 6 participants | 14 participants |
| Sex: Female, Male Female | 7 Participants | 2 Participants | 9 Participants |
| Sex: Female, Male Male | 1 Participants | 4 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 6 |
| serious Total, serious adverse events | 2 / 8 | 0 / 6 |
Outcome results
Primary
Mean Change From Baseline BCVA
Vision was measured using a standard ETDRS chart at baseline and each subsequent monthly visit.
Time frame: Baseline to month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravitreal Ranibizumab 0.5mg | Mean Change From Baseline BCVA | 14 Letters (ETDRS chart) | Standard Deviation 10 |
| Intravitreal Ranibizumab 1.0mg | Mean Change From Baseline BCVA | 5 Letters (ETDRS chart) | Standard Deviation 6 |
Secondary
Change in Mean Best Corrected Visual Acuity From Baseline
Time frame: months 1-12
Secondary
Excess Foveal Thickness
Time frame: Month 6 and 12
Secondary
Mean Change From Baseline in Center Point Thickness
Time frame: months 1-12
Secondary
Percentage of Patients With CFT Less Than 300um
Time frame: Month 6 and 12
Secondary
Total Number of Ranibizumab Injections
Time frame: month 12