Retinal Vein Occlusions
Conditions
Brief summary
Comparative study to see if treating with Osurdex in addition to Avastin in patients with retinal vein occlusions helps increased visual acuity outcomes
Interventions
DRUGAvastin
1.25mg intravitreally
DRUGOsurdex
0.7mg intravitreally
Sponsors
Maturi, Raj K., M.D., P.C.
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
* male or female age 18 years or older * Branch retinal vein occlusion or central retinal vein occlusion of less than one year duration * Best correct visual acuity of greater than 24 and less than 80 * Presence of macular edema defined as OCT central subfield thickness of \>250
Exclusion criteria
* intravitreal anti-VEGF treatment in study eye within six weeks of baseline * intravitreal steroid treatment in the study eye within eight weeks of baseline visit * PRP in the study eye within 4 month of baseline visit * Active iris neovascularization in study eye * Uncontrolled systemic disease * Known history of IOP elevation in response to corticosteroid treatment that is not controlled on 2 glaucoma medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Visual Acuity at 6 Months | 6 months | Visual Acuity was measured with ETDRS visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Injections Needed | baseline to 6 months | number of Avastin and Ozurdex injections needed |
| Change in Macular Thickness and Macular Volume | 6 months | OCT central subfield thickness measured in microns |
Countries
United States
Participant flow
Recruitment details
The study was conducted at a single center. The first subject for this study was screened on 18MAR2010 and enrolled on 26MAR2010. The subjects were existing patients in our medical clinic.
Pre-assignment details
In total there were 10 screen failures; 4 did not meet the visual acuity requirements,3 did not meet the OCT requirements. One subject withdrew consent prior to randomization and one withdrew prior to randomization due to health issues
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 micros | 15 |
| Group 2 Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals wehn the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 microns. | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Group 1 | Group 2 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 11 Participants | 20 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 4 Participants | 10 Participants |
| Age, Continuous | 67 years STANDARD_DEVIATION 13 | 69 years STANDARD_DEVIATION 19 | 68 years STANDARD_DEVIATION 16 |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Male | 10 Participants | 8 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 15 | 15 / 15 |
| serious Total, serious adverse events | 4 / 15 | 3 / 15 |
Outcome results
Primary
Change From Baseline Visual Acuity at 6 Months
Visual Acuity was measured with ETDRS visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Change From Baseline Visual Acuity at 6 Months | 2.3 ETDRS score | Standard Deviation 7.7 |
| Group 2 | Change From Baseline Visual Acuity at 6 Months | 0.1 ETDRS score | Standard Deviation 13.3 |
Secondary
Change in Macular Thickness and Macular Volume
OCT central subfield thickness measured in microns
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Change in Macular Thickness and Macular Volume | 45.4 microns | Standard Deviation 100.1 |
| Group 2 | Change in Macular Thickness and Macular Volume | -55.6 microns | Standard Deviation 39.7 |
Secondary
Number of Injections Needed
number of Avastin and Ozurdex injections needed
Time frame: baseline to 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Number of Injections Needed | 14 injections |
| Group 2 | Number of Injections Needed | 11 injections |