Macular Edema, Retinal Vein Occlusion
Conditions
Brief summary
Epidemiological study of Ozurdex® in sites treating patients with retinal vein occlusion.
Interventions
DRUGdexamethasone intravitreal implant
dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Macular oedema due to retinal vein occlusion
Exclusion criteria
* Not living in metropolitan France
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Baseline, Month 6 | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in BCVA in the Study Eye Diagnosed With Central Retinal Vein Occlusion (CRVO) | Baseline, Month 6 | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. CRVO is a blockage of the main vein in the retina. |
| Change From Baseline in BCVA in the Study Eye in Previously Treatment Naïve Patients | Baseline, Month 6 | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Treatment naïve patients have not been previously treated for retinal vein occlusion. |
| Change From Baseline in BCVA in the Study Eye in Patients Previously Treated With Ozurdex® | Baseline, Month 6 | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Previous treatment for retinal vein occlusion was Ozurdex®. |
| Change From Baseline in BCVA in the Study Eye in Patients Previously Naïve to Ozurdex® Treatment | Baseline, Month 6 | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Patients naive to Ozurdex® have not been previously treated for retinal vein occlusion. |
| Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset <3 Months | Baseline, Month 6 | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. The onset of macular edema was \<3 months prior to treatment. |
| Change From Baseline in BCVA in the Study Eye Diagnosed With Branch Retinal Vein Occlusion (BRVO) | Baseline, Month 6 | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. BRVO is a blockage of the small veins in the retina. |
| Change From Baseline in BCVA in the Study Eye in Patients Only Treated With Ozurdex® | Baseline, Month 6 | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Patients had only been previously treated with Ozurdex®. |
| Change From Baseline in BCVA in the Study Eye in Patients Receiving Ozurdex® and Then Other RVO Treatments | Baseline, Month 6 | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Patients were previously treated with Ozurdex® and then switched to other RVO treatment during the study. |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Baseline, Week 6, Month 4, Month 12, Month 18, Month 24 | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. |
| Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye | Baseline, Month 24 | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening. |
| Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset ≥3 Months | Baseline, Month 6 | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. The onset of macular edema was ≥3 months prior to treatment. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ozurdex® (Dexamethasone Intravitreal Implant) dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment. | 375 |
| Total | 375 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 23 |
| Overall Study | Lost to Follow-up | 9 |
| Overall Study | Other reasons | 11 |
| Overall Study | Protocol Violation | 43 |
| Overall Study | Treatment satisfaction | 10 |
Baseline characteristics
| Characteristic | Ozurdex® (Dexamethasone Intravitreal Implant) |
|---|---|
| Age, Continuous | 70.31 Years STANDARD_DEVIATION 11.19 |
| Sex: Female, Male Female | 169 Participants |
| Sex: Female, Male Male | 206 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 252 / 375 |
| serious Total, serious adverse events | 98 / 375 |
Outcome results
Primary
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened.
Time frame: Baseline, Month 6
Population: All enrolled patients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ozurdex® (Dexamethasone Intravitreal Implant) | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Baseline | 47.56 Letters | Standard Deviation 21.21 |
| Ozurdex® (Dexamethasone Intravitreal Implant) | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Change from Baseline at Month 6 (N=323) | 5.09 Letters | Standard Deviation 19.02 |
Secondary
Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset <3 Months
BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. The onset of macular edema was \<3 months prior to treatment.
Time frame: Baseline, Month 6
Population: All enrolled patients with macular edema onset \<3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ozurdex® (Dexamethasone Intravitreal Implant) | Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset <3 Months | Baseline | 43.27 Letters | Standard Deviation 22.83 |
| Ozurdex® (Dexamethasone Intravitreal Implant) | Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset <3 Months | Change from Baseline at Month 6 | 8.53 Letters | Standard Deviation 20.5 |
Secondary
Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset ≥3 Months
BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. The onset of macular edema was ≥3 months prior to treatment.
Time frame: Baseline, Month 6
Population: All enrolled patients with macular edema onset ≥3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ozurdex® (Dexamethasone Intravitreal Implant) | Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset ≥3 Months | Baseline | 51.44 Letters | Standard Deviation 19 |
| Ozurdex® (Dexamethasone Intravitreal Implant) | Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset ≥3 Months | Change from Baseline at Month 6 | 1.96 Letters | Standard Deviation 17.47 |
Secondary
Change From Baseline in BCVA in the Study Eye Diagnosed With Branch Retinal Vein Occlusion (BRVO)
BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. BRVO is a blockage of the small veins in the retina.
Time frame: Baseline, Month 6
Population: All enrolled patients with BRVO
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ozurdex® (Dexamethasone Intravitreal Implant) | Change From Baseline in BCVA in the Study Eye Diagnosed With Branch Retinal Vein Occlusion (BRVO) | Baseline | 52.80 Letters | Standard Deviation 17.42 |
| Ozurdex® (Dexamethasone Intravitreal Implant) | Change From Baseline in BCVA in the Study Eye Diagnosed With Branch Retinal Vein Occlusion (BRVO) | Change from Baseline at Month 6 | 5.50 Letters | Standard Deviation 19.59 |
Secondary
Change From Baseline in BCVA in the Study Eye Diagnosed With Central Retinal Vein Occlusion (CRVO)
BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. CRVO is a blockage of the main vein in the retina.
Time frame: Baseline, Month 6
Population: All enrolled patients with CRVO
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ozurdex® (Dexamethasone Intravitreal Implant) | Change From Baseline in BCVA in the Study Eye Diagnosed With Central Retinal Vein Occlusion (CRVO) | Baseline | 41.45 Letters | Standard Deviation 23.54 |
| Ozurdex® (Dexamethasone Intravitreal Implant) | Change From Baseline in BCVA in the Study Eye Diagnosed With Central Retinal Vein Occlusion (CRVO) | Change from Baseline at Month 6 | 4.63 Letters | Standard Deviation 18.38 |
Secondary
Change From Baseline in BCVA in the Study Eye in Patients Only Treated With Ozurdex®
BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Patients had only been previously treated with Ozurdex®.
Time frame: Baseline, Month 6
Population: All enrolled patients only treated with Ozurdex
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ozurdex® (Dexamethasone Intravitreal Implant) | Change From Baseline in BCVA in the Study Eye in Patients Only Treated With Ozurdex® | Baseline | 49.28 Letters | Standard Deviation 19.23 |
| Ozurdex® (Dexamethasone Intravitreal Implant) | Change From Baseline in BCVA in the Study Eye in Patients Only Treated With Ozurdex® | Change from Baseline at Month 6 | 5.48 Letters | Standard Deviation 18.77 |
Secondary
Change From Baseline in BCVA in the Study Eye in Patients Previously Naïve to Ozurdex® Treatment
BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Patients naive to Ozurdex® have not been previously treated for retinal vein occlusion.
Time frame: Baseline, Month 6
Population: All enrolled patients previously naïve to Ozurdex® treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ozurdex® (Dexamethasone Intravitreal Implant) | Change From Baseline in BCVA in the Study Eye in Patients Previously Naïve to Ozurdex® Treatment | Baseline | 45.29 Letters | Standard Deviation 20.2 |
| Ozurdex® (Dexamethasone Intravitreal Implant) | Change From Baseline in BCVA in the Study Eye in Patients Previously Naïve to Ozurdex® Treatment | Change from Baseline at Month 6 | 8.39 Letters | Standard Deviation 21.1 |
Secondary
Change From Baseline in BCVA in the Study Eye in Patients Previously Treated With Ozurdex®
BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Previous treatment for retinal vein occlusion was Ozurdex®.
Time frame: Baseline, Month 6
Population: All enrolled patients previously treated with Ozurdex®
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ozurdex® (Dexamethasone Intravitreal Implant) | Change From Baseline in BCVA in the Study Eye in Patients Previously Treated With Ozurdex® | Baseline | 52.46 Letters | Standard Deviation 18.9 |
| Ozurdex® (Dexamethasone Intravitreal Implant) | Change From Baseline in BCVA in the Study Eye in Patients Previously Treated With Ozurdex® | Change from Baseline at Month 6 | 1.95 Letters | Standard Deviation 16.03 |
Secondary
Change From Baseline in BCVA in the Study Eye in Patients Receiving Ozurdex® and Then Other RVO Treatments
BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Patients were previously treated with Ozurdex® and then switched to other RVO treatment during the study.
Time frame: Baseline, Month 6
Population: All enrolled patients receiving Ozurdex® and then other RVO treatments
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ozurdex® (Dexamethasone Intravitreal Implant) | Change From Baseline in BCVA in the Study Eye in Patients Receiving Ozurdex® and Then Other RVO Treatments | Baseline | 43.97 Letters | Standard Deviation 24.57 |
| Ozurdex® (Dexamethasone Intravitreal Implant) | Change From Baseline in BCVA in the Study Eye in Patients Receiving Ozurdex® and Then Other RVO Treatments | Change from Baseline at Month 6 | 4.25 Letters | Standard Deviation 19.61 |
Secondary
Change From Baseline in BCVA in the Study Eye in Previously Treatment Naïve Patients
BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Treatment naïve patients have not been previously treated for retinal vein occlusion.
Time frame: Baseline, Month 6
Population: All enrolled patients who were treatment naïve
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ozurdex® (Dexamethasone Intravitreal Implant) | Change From Baseline in BCVA in the Study Eye in Previously Treatment Naïve Patients | Baseline | 43.94 Letters | Standard Deviation 23.12 |
| Ozurdex® (Dexamethasone Intravitreal Implant) | Change From Baseline in BCVA in the Study Eye in Previously Treatment Naïve Patients | Change from Baseline at Month 6 | 7.45 Letters | Standard Deviation 20 |
Secondary
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened.
Time frame: Baseline, Week 6, Month 4, Month 12, Month 18, Month 24
Population: All enrolled patients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ozurdex® (Dexamethasone Intravitreal Implant) | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Baseline | 47.6 Letters | Standard Deviation 21.2 |
| Ozurdex® (Dexamethasone Intravitreal Implant) | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Change from Baseline at Week 6 (N=350) | 11.41 Letters | Standard Deviation 16.4 |
| Ozurdex® (Dexamethasone Intravitreal Implant) | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Change from Baseline at Month 4 (N=337) | 3.08 Letters | Standard Deviation 18.2 |
| Ozurdex® (Dexamethasone Intravitreal Implant) | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Change from Baseline at Month 12 (N=306) | 2.85 Letters | Standard Deviation 21.4 |
| Ozurdex® (Dexamethasone Intravitreal Implant) | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Change from Baseline at Month 18 (N=287) | 3.02 Letters | Standard Deviation 22.2 |
| Ozurdex® (Dexamethasone Intravitreal Implant) | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Change from Baseline at Month 24 (N=274) | 4.64 Letters | Standard Deviation 22.3 |
Secondary
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye
BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.
Time frame: Baseline, Month 24
Population: All enrolled patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ozurdex® (Dexamethasone Intravitreal Implant) | Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye | 38.7 Percentage of Patients |