Retinal Vein Occlusion
Conditions
Keywords
RVO, CRVO, BRVO, Horizon, Bravo, Cruise
Brief summary
This study evaluates long-term safety in patients with macular edema due to Retinal Vein Occlusion (RVO) originally enrolled in the BRAVO & CRUISE trials and subsequently followed in the HORIZON extension trial.
Detailed description
There is strong evidence that ranibizumab provides benefit in subjects with macular edema due to RVO; however, some subjects required continued injections for years to maintain those benefits. It is likely that such subjects have continued production of VEGF (Vascular Endothelial Growth Factor) from areas of nonperfused retina in the periphery. One strategy is to perform scatter photocoagulation to areas of nonperfusion to reduce continued production of VEGF, but it is important to know if visual benefits are maintained when this is done, because if it is not, it would be better to continue intermittent injections of ranibizumab.
Interventions
DRUGranibizumab
Intravitreal ranibizumab, .5mg dose, PRN but not less than 21 days apart.
OTHERPeripheral Laser
Areas of nonperfusion identified on wide field angiograms will receive laser, if the patient is continuing to require ranibizumab injections.
Sponsors
The Macula Foundation, Inc.
Genentech, Inc.
Peter A Campochiaro, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent and authorization of use and disclosure of protected health information * Age greater than or equal to 18 years * Completion of 12 months in BRAVO or CRUISE trials, with subsequent follow-up in the HORIZON extension study. Exit from HORIZON should be within 90 days of enrollment
Exclusion criteria
* Pregnancy (positive pregnancy test) or lactation * Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch. * Any condition that the investigator believes would pose a significant hazard to the subject if investigational therapy were initiated. * Inability to comply with study or follow up procedures * Participation in another simultaneous medical investigation or trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Serious Adverse Events. | 24 mos | Record the serious adverse events, both ocular and non-ocular to gather long-term safety data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Changes in Visual Acuity | 24 mos from study baseline | Mean changes in visual acuity. Visual acuity is measured using standard ETDRS (Early Treatment Diabetic Retinopathy Study) charts which measure visual acuity in terms of letters( ETDRS Letters) read at a distance of 4 meters away from the chart. The ETDRS letters Score can be from 0 to 100, with 0 representing poor vision and 100 representing best vision. |
| Mean Change in Retinal Thickness | 24 mos from study baseline | Mean change in retinal thickness as measured by OCT (Optical Coherence Tomography). |
Countries
United States
Participant flow
Recruitment details
66 retinal vein occlusion patients from the HORIZON study(NCT01198327)were enrolled from 7 sites for long term follow up. The sites were: Wilmer Eye Institute, Ophthalmic Consultants of Boston, Retina Consultants of New Jersey, Retina Consultants Macula Group,Retina Consultants of Houston, Southeast Retina and Retina Vitreous Associates
Participants by arm
| Arm | Count |
|---|---|
| Ranibizumab as Needed Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion. | 66 |
| Total | 66 |
Baseline characteristics
| Characteristic | Ranibizumab as Needed |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 43 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Age, Continuous | 67.9 years STANDARD_DEVIATION 10.8 |
| Region of Enrollment United States | 66 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 53 / 66 |
| serious Total, serious adverse events | 17 / 66 |
Outcome results
Primary
Incidence of Serious Adverse Events.
Record the serious adverse events, both ocular and non-ocular to gather long-term safety data.
Time frame: 24 mos
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ranibizumab as Needed | Incidence of Serious Adverse Events. | 17 number of serious adverse events |
Secondary
Mean Change in Retinal Thickness
Mean change in retinal thickness as measured by OCT (Optical Coherence Tomography).
Time frame: 24 mos from study baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ranibizumab as Needed | Mean Change in Retinal Thickness | -426.0 microns | Standard Deviation 270.1 |
| Ranibizumab as Needed -BRVO | Mean Change in Retinal Thickness | -236.2 microns | Standard Deviation 230.3 |
Secondary
Mean Changes in Visual Acuity
Mean changes in visual acuity. Visual acuity is measured using standard ETDRS (Early Treatment Diabetic Retinopathy Study) charts which measure visual acuity in terms of letters( ETDRS Letters) read at a distance of 4 meters away from the chart. The ETDRS letters Score can be from 0 to 100, with 0 representing poor vision and 100 representing best vision.
Time frame: 24 mos from study baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ranibizumab as Needed | Mean Changes in Visual Acuity | 14.0 ETDRS letters | Standard Deviation 20.9 |
| Ranibizumab as Needed -BRVO | Mean Changes in Visual Acuity | 20.1 ETDRS letters | Standard Deviation 17.2 |