Retinal Vein Occlusion, Macular Edema
Conditions
Keywords
BRVO, CRVO, Macular Edema, Anti-VEGF, Ozurdex
Brief summary
To test the efficacy of a 0.7 mg intravitreal dexamethasone implant (Ozurdex®) on macular function and recalcitrant macular edema associated with retinal vein occlusion following treatment with 2 or more prior intravitreal anti-VEGF drug injections.
Detailed description
The efficacy of the DEX implant on macular edema for RVO is well established in multiple clinical trials. However, the duration and frequency of re-treatment have not been extensively explored. In addition, no prior studies have tested the efficacy of the DEX implant on retinal and macular function using diagnostic testing measurements such as multi-focal ERG, microperimetry and RAM testing. Since VA and OCT outcomes do not always correlate, these other assessments (mf-ERG, microperimetry, RAM testing) may be useful as early predictors of when or if patients should be retreated. This study will assess 2 groups (0.7mg PRN and 0.7mg Q16 weeks) and assess high resolution OCT, RAM testing, microperimetry, and Multi-focal ERG outcomes. For the PRN group retreated based on any fluid on OCT, we will investigate if microperimetry or multifocal ERG changes would have been an earlier predictor of fluid returning.
Interventions
DRUGOzurdex
0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies
Sponsors
Allergan
Retina Macula Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Presence of central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO) * Prior treatment with \>= 2 intravitreal anti-VEGF injections but no treatment in last 45 days. * Age 18 years or older * ETDRS Visual acuity between 3 and 72 letters and approximate Snellen equivalent of 20/25 to 20/800 * Central foveal thickness \>275 microns or presence of cystic edema on OCT studies. * For sexually active women of childbearing potential, agreement to the use of an appropriate form of contraception (or abstinence) for the duration of the study. * Ability to provide written informed consent • Capable of complying with study protocol
Exclusion criteria
* History of steroid-related glaucoma (steroid response) requiring more than one topical glaucoma medication. * Intraocular injection of steroid medication within prior 4 months * Evidence of significant retinal ischemia on fluorescein angiography in the opinion of the treating physician. * Previous laser photocoagulation within 4 months of study * Concurrent ocular disease (e.g proliferative diabetic retinopathy, geographic atrophy) that would limit visual acuity in the opinion of the treating physician * Patients who are pregnant. * Unwilling or unable to follow or comply with all study related procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Macular Function Using Microperimetry | baseline to 48 weeks | To determine if there is change in mean macular sensitivity using microperimetry at 48 weeks compared to baseline for both the PRN and Q16weeks treatment groups |
| Macular Function Using Multi-focal ERG | baseline to 48 weeks | To determine if there is a change in central amplitude responses using multifocal ERG at 48 weeks compared to baseline values for both the PRN and Q16weeks treatment groups |
Secondary
| Measure | Time frame |
|---|---|
| To Determine if There is a Change in Visual Acuity (Number of ETDRS Letters) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups | baseline to 48 weeks |
| To Determine if There is a Change in Central Foveal Thickness (Microns on High Resolution OCT) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups | baseline to 48 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ozurdex PRN Drug: dexamethasone intravitreal implant Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and PRN every 16 weeks
Other Name: Ozurdex PRN | 5 |
| Ozurdex q16 Weeks Drug: dexamethasone intravitreal implant Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and every 16 weeks
Other Name: Ozurdex PRN | 5 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Death | 0 | 1 |
Baseline characteristics
| Characteristic | Ozurdex q16 Weeks | Ozurdex PRN | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 2 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 3 Participants | 5 Participants |
| Age, Continuous | 63.3 years STANDARD_DEVIATION 8 | 69.1 years STANDARD_DEVIATION 5.7 | 66.2 years STANDARD_DEVIATION 4.7 |
| Region of Enrollment United States | 5 participants | 5 participants | 10 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 1 / 5 |
| other Total, other adverse events | 0 / 5 | 1 / 5 |
| serious Total, serious adverse events | 1 / 5 | 0 / 5 |
Outcome results
Primary
Macular Function Using Microperimetry
To determine if there is change in mean macular sensitivity using microperimetry at 48 weeks compared to baseline for both the PRN and Q16weeks treatment groups
Time frame: baseline to 48 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ozurdex PRN | Macular Function Using Microperimetry | Baseline | 2.7 dB | Standard Error 0.8 |
| Ozurdex PRN | Macular Function Using Microperimetry | Final Visit | 4.2 dB | Standard Error 1.7 |
| Ozurdex Q16 Weeks | Macular Function Using Microperimetry | Baseline | 12.7 dB | Standard Error 2.6 |
| Ozurdex Q16 Weeks | Macular Function Using Microperimetry | Final Visit | 10.7 dB | Standard Error 1.9 |
Primary
Macular Function Using Multi-focal ERG
To determine if there is a change in central amplitude responses using multifocal ERG at 48 weeks compared to baseline values for both the PRN and Q16weeks treatment groups
Time frame: baseline to 48 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ozurdex PRN | Macular Function Using Multi-focal ERG | Final Visit | 18.20 nV/deg2 | Standard Error 4.03 |
| Ozurdex PRN | Macular Function Using Multi-focal ERG | Baseline | 3.61 nV/deg2 | Standard Error 0.39 |
| Ozurdex Q16 Weeks | Macular Function Using Multi-focal ERG | Baseline | 6.62 nV/deg2 | Standard Error 0.83 |
| Ozurdex Q16 Weeks | Macular Function Using Multi-focal ERG | Final Visit | 30.18 nV/deg2 | Standard Error 9.6 |
Secondary
To Determine if There is a Change in Central Foveal Thickness (Microns on High Resolution OCT) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups
Time frame: baseline to 48 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ozurdex PRN | To Determine if There is a Change in Central Foveal Thickness (Microns on High Resolution OCT) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups | Baseline | 501.7 microns | Standard Error 59.7 |
| Ozurdex PRN | To Determine if There is a Change in Central Foveal Thickness (Microns on High Resolution OCT) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups | Final Visit | 361.4 microns | Standard Error 47.3 |
| Ozurdex Q16 Weeks | To Determine if There is a Change in Central Foveal Thickness (Microns on High Resolution OCT) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups | Baseline | 353.5 microns | Standard Error 27 |
| Ozurdex Q16 Weeks | To Determine if There is a Change in Central Foveal Thickness (Microns on High Resolution OCT) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups | Final Visit | 326.7 microns | Standard Error 21.2 |
Secondary
To Determine if There is a Change in Visual Acuity (Number of ETDRS Letters) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups
Time frame: baseline to 48 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ozurdex PRN | To Determine if There is a Change in Visual Acuity (Number of ETDRS Letters) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups | Baseline | 46.4 ETDRS letters | Standard Error 7.1 |
| Ozurdex PRN | To Determine if There is a Change in Visual Acuity (Number of ETDRS Letters) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups | Final Visit | 27.8 ETDRS letters | Standard Error 8.4 |
| Ozurdex Q16 Weeks | To Determine if There is a Change in Visual Acuity (Number of ETDRS Letters) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups | Baseline | 55.6 ETDRS letters | Standard Error 7.5 |
| Ozurdex Q16 Weeks | To Determine if There is a Change in Visual Acuity (Number of ETDRS Letters) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups | Final Visit | 53.2 ETDRS letters | Standard Error 8.5 |