Non-Ischemic Central Retinal Vein Occlusion
Conditions
Brief summary
This is a study designed to determine if the addition of Ozurdex® to bevacizumab (Avastin®) eye injections reduces the need for repeat bevacizumab eye injections in patients with nonischemic central retina vein occlusion.
Detailed description
This is a multicenter clinical study designed to determine if the addition of Ozurdex® injection to bevacizumab (Avastin®) eye injections reduces the need for repeat bevacizumab eye injections in patients with nonischemic central retina vein occlusion.
Interventions
DRUGActive bevacizumab and Sham dexamethasone
Bevacizumab: 25 mg/mL, PRN dosing Sham dexamethasone intravitreal implant: blunt needling of the sclera with no penetration of the globe
DRUGActive bevacizumab and Active dexamethasone
Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose
Sponsors
Texas Retina Associates
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
Yes
Inclusion criteria
1. male or female subjects (aged 18 or older); 2. provide written informed consent and sign/date a health information release; 3. women of childbearing potential must be willing to practice effective contraception for the duration of the study.
Exclusion criteria
1. any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; 2. use of systemic steroids within 1 month prior to Baseline Visit (Visit 1) or anticipated use at any time during the study (inhaled and intranasal steroids are allowed); 3. sitting systolic blood pressure equal to or greater than 160 mmHg or diastolic blood pressure equal to or greater than 100 mmHg at the Baseline Visit (Visit 1); 4. use of warfarin, heparin, enoxaparin or similar anticoagulants within 2 weeks prior to Baseline Visit (Visit 1) or anticipated use at any time during the study; 5. known allergy or hypersensitivity to the study medications or their components; 6. previous enrollment in an Ozurdex® clinical trial or previous use of an Ozurdex® implant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks | 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Secondary Efficacy Endpoint is the Visual Acuity Score Based on Best Corrected Visual Acuity (BCVA) at Week 24 | 24 weeks | The secondary efficacy endpoint is the visual acuity score based on best corrected visual acuity (BCVA) at Week 24 Change in BCVA at Week 24 from baseline |
Countries
United States
Participant flow
Recruitment details
A total of 68 participants ≥18 years of age with a diagnosis of central retinal vein occlusion (CRVO) as determined by fundus photography and fluorescein angiography were enrolled in the study at 5 clinical centers.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Active bevacizumab (Avastin®) and Sham Ozurdex®
Active bevacizumab and Sham dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Sham dexamethasone intravitreal implant: blunt needling of the sclera with no penetration of the globe | 35 |
| Group 2 Active bevacizumab (Avastin®) and Active Ozurdex®
Active bevacizumab and Active dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose | 33 |
| Total | 68 |
Baseline characteristics
| Characteristic | Group 1 | Group 2 | Total |
|---|---|---|---|
| Age, Continuous | 66.4 years STANDARD_DEVIATION 15 | 70.7 years STANDARD_DEVIATION 12.6 | 68.5 years STANDARD_DEVIATION 14 |
| Baseline best corrected visual acuity (BCVA) in Study Eye | 49.6 letters STANDARD_DEVIATION 18.2 | 55.7 letters STANDARD_DEVIATION 17.2 | 52.5 letters STANDARD_DEVIATION 17.8 |
| Baseline Central Foveal Thickness in Fellow Eye | 209.3 microns STANDARD_DEVIATION 39.1 | 213.1 microns STANDARD_DEVIATION 35.6 | 211.2 microns STANDARD_DEVIATION 36.9 |
| Baseline Central Foveal Thickness in Study Eye | 264.5 microns STANDARD_DEVIATION 68.9 | 262.1 microns STANDARD_DEVIATION 70 | 263.3 microns STANDARD_DEVIATION 68.8 |
| Baselinen best corrected visual acuity (BCVA) in Fellow Eye | 82.0 letters STANDARD_DEVIATION 12.6 | 82.2 letters STANDARD_DEVIATION 9.6 | 82.1 letters STANDARD_DEVIATION 11.2 |
| Previous Injections Bevacizumab | 5 Participants | 8 Participants | 13 Participants |
| Previous Injections Bevacizumab and Aflibercept | 3 Participants | 0 Participants | 3 Participants |
| Previous Injections Bevacizumab and Ranibizumab | 1 Participants | 1 Participants | 2 Participants |
| Previous Injections No Injection | 22 Participants | 21 Participants | 43 Participants |
| Previous Injections Ranibizumab | 4 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Black | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Caucasian | 25 Participants | 24 Participants | 49 Participants |
| Race/Ethnicity, Customized Hispanic | 5 Participants | 5 Participants | 10 Participants |
| Race/Ethnicity, Customized Not Reported | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Female | 13 Participants | 16 Participants | 29 Participants |
| Sex: Female, Male Male | 22 Participants | 17 Participants | 39 Participants |
| Study Eye Left Eye | 17 Participants | 18 Participants | 35 Participants |
| Study Eye Right Eye | 18 Participants | 15 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 33 |
| other Total, other adverse events | 0 / 35 | 0 / 33 |
| serious Total, serious adverse events | 0 / 35 | 0 / 33 |
Outcome results
Primary
The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks
Time frame: 24 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 | The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks | 4 PRN Injections | 1 Participants |
| Group 1 | The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks | 1 PRN Injection | 13 Participants |
| Group 1 | The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks | 2 PRN Injections | 10 Participants |
| Group 1 | The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks | 3 PRN Injections | 6 Participants |
| Group 1 | The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks | 0 PRN Injections | 5 Participants |
| Group 2 | The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks | 3 PRN Injections | 0 Participants |
| Group 2 | The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks | 4 PRN Injections | 0 Participants |
| Group 2 | The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks | 0 PRN Injections | 19 Participants |
| Group 2 | The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks | 2 PRN Injections | 3 Participants |
| Group 2 | The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks | 1 PRN Injection | 11 Participants |
p-value: 0.00002Cochran-Mantel-Haenszel
Secondary
The Secondary Efficacy Endpoint is the Visual Acuity Score Based on Best Corrected Visual Acuity (BCVA) at Week 24
The secondary efficacy endpoint is the visual acuity score based on best corrected visual acuity (BCVA) at Week 24 Change in BCVA at Week 24 from baseline
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | The Secondary Efficacy Endpoint is the Visual Acuity Score Based on Best Corrected Visual Acuity (BCVA) at Week 24 | 16.20 letters | Standard Deviation 15.49 |
| Group 2 | The Secondary Efficacy Endpoint is the Visual Acuity Score Based on Best Corrected Visual Acuity (BCVA) at Week 24 | 13.55 letters | Standard Deviation 19.41 |
p-value: 0.5390% CI: [-4.43, 9.74]t-test, 1 sided