Macular Edema, Central Retinal Vein Occlusion
Conditions
Keywords
Macular Edema, Central Retinal Vein Occlusion
Brief summary
The purpose of this study is to compare visual improvement and total number of intraocular injections in eyes with macular edema following central retinal vein occlusion (CRVO)after initial treatment with Ozurdex (dexamethasone implant) or Avastin (bevacizumab).
Interventions
DRUGOzurdex
Ozurdex, 0.7mg dexamethasone
DRUGAvastin
Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.
Sponsors
Long Island Vitreoretinal Consultants
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Presence of central retinal vein occlusion (CRVO) * Age 18 years or older * ETDRS (Early Treatment Diabetic Retinopathy Study) Visual acuity between 3 and 72 letters and approximate Snellen equivalent of 20/40 to 20/800 * OCT Central foveal thickness \>250 microns * Negative pregnancy test for women of childbearing potential * Ability to provide written informed consent * Capable of complying with study protocol
Exclusion criteria
* History of glaucoma in the study eye with intraocular pressure \>21mmHg on more than one topical medication. Combination drugs are considered more than one medication * History of steroid-related glaucoma (steroid response) * Previous intraocular injection of steroid medication within 90 days * Avastin (bevacizumab) or Lucentis (ranibizumab) within 60 days * Evidence of significant retinal ischemia on fluorescein angiography in the opinion of the treating physician * Previous intraocular surgery (e.g. Cataract Surgery) with in 60 days * Concurrent ocular disease that would limit visual acuity in the opinion of the treating physician * Dense cataract that precludes clinical examination and retinal imaging of the retina * History of allergy to dexamethasone, bevacizumab, betadine * Ocular or systemic conditions that may pose a threat to the health of the subject in the opinion of the treating physician * Unwilling or unable to follow or comply with all study related procedures * Current participation in another clinical medical investigation or trial or has received any investigational drug within 12 weeks prior to enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Change in Visual Acuity (Number of ETDRS Early Treatment Diabetic Retinopathy Study Letters), at Month 6 as Compared With Baseline in Each Treatment Arm | Baseline - Month 6 | The change in visual acuity (number of ETDRS - Early Treatment Diabetic Retinopathy Study letters), at Month 6 as compared with baseline in each treatment arm |
| The Total Number of Additional Avastin Injections Following Initial Treatment in Each Treatment Arm | Baseline - Month 6 | Total Number of addiitonal Avastin injections during study- From baseline to Month 6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Central Mean Thickness Based on OCT | Baseline to 6 Months | Change in Central Mean Thickness based on OCT from baseline to Month 6t |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.
Ozurdex: Ozurdex, 0.7mg dexamethasone
Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed. | 14 |
| Group 2 Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.
Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed. | 13 |
| Total | 27 |
Baseline characteristics
| Characteristic | Group 2 | Group 1 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 9 Participants | 19 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 5 Participants | 8 Participants |
| Age, Continuous | 74.3 years | 68.8 years | 71.3 years |
| Region of Enrollment United States | 13 Participants | 14 Participants | 27 Participants |
| Sex: Female, Male Female | 7 Participants | 6 Participants | 13 Participants |
| Sex: Female, Male Male | 6 Participants | 8 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 13 |
| other Total, other adverse events | 0 / 14 | 0 / 13 |
| serious Total, serious adverse events | 0 / 14 | 0 / 13 |
Outcome results
Primary
The Change in Visual Acuity (Number of ETDRS Early Treatment Diabetic Retinopathy Study Letters), at Month 6 as Compared With Baseline in Each Treatment Arm
The change in visual acuity (number of ETDRS - Early Treatment Diabetic Retinopathy Study letters), at Month 6 as compared with baseline in each treatment arm
Time frame: Baseline - Month 6
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1 | The Change in Visual Acuity (Number of ETDRS Early Treatment Diabetic Retinopathy Study Letters), at Month 6 as Compared With Baseline in Each Treatment Arm | 11.1 Letters Gain/Loss |
| Group 2 | The Change in Visual Acuity (Number of ETDRS Early Treatment Diabetic Retinopathy Study Letters), at Month 6 as Compared With Baseline in Each Treatment Arm | 16.1 Letters Gain/Loss |
Primary
The Total Number of Additional Avastin Injections Following Initial Treatment in Each Treatment Arm
Total Number of addiitonal Avastin injections during study- From baseline to Month 6
Time frame: Baseline - Month 6
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1 | The Total Number of Additional Avastin Injections Following Initial Treatment in Each Treatment Arm | 2.5 Injections |
| Group 2 | The Total Number of Additional Avastin Injections Following Initial Treatment in Each Treatment Arm | 5.1 Injections |
Secondary
Change in Central Mean Thickness Based on OCT
Change in Central Mean Thickness based on OCT from baseline to Month 6t
Time frame: Baseline to 6 Months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group 1 | Change in Central Mean Thickness Based on OCT | Initial OCT Measure at Basline | 703 Microns on OCT |
| Group 1 | Change in Central Mean Thickness Based on OCT | Final OCT measure at Month 6 | 353 Microns on OCT |
| Group 2 | Change in Central Mean Thickness Based on OCT | Initial OCT Measure at Basline | 790 Microns on OCT |
| Group 2 | Change in Central Mean Thickness Based on OCT | Final OCT measure at Month 6 | 408 Microns on OCT |