CLINICAL EFFICACY
- For diabetic macular edema (DME)
- For macular edema following branch retinal vein occlusion (BRVO)
or central retinal vein occlusion (CRVO) - For noninfectious posterior segment uveitis
-
Study Design/Patient Demographics
-
Efficacy in All Randomized Patients
-
Efficacy in Pseudophakic Patients
-
Efficacy in Phakic Patients
A Phase 3, Multicenter, Masked, Randomized, Sham-Controlled, 3-Year Trial in DME1,9
- In this phase 3 study, DME patients were randomized to:
- Sham (needleless applicator) (n = 328)
- OZURDEX® (n = 328)
- Specified treatment interval: no more than approximately every 6 months
- Evaluations performed at baseline, every 45 days during year 1, and every 3 months during years 2 and 3
- Escape therapy could be administered at the investigator's discretion at any point during the study
- Patients who received escape therapy were withdrawn from the study
- Efficacy analyses used the last-observation-carried-forward (LOCF) method for these patients
- Key efficacy outcome measure9
- Primary endpoint: Percentage of patients gaining ≥ 15 letters (3 lines) in BCVA from baseline
- Key Safety measures1,9
- Adverse events
- Intraocular pressure
- Biomicroscopy
- Indirect ophthalmoscopy
- Retroillumination photographs for opacity grading
- Blood pressure and pulse rate
Results in overall patient population
- OZURDEX® sustained clinically significant vision improvements throughout the 3-year MEAD study1
All Randomized Patients: Visual Acuity Outcomes at
Month
39
1
Measurement
OZURDEX®
(n = 328)
(n = 328)
Sham
(n = 328)
(n = 328)
Estimated difference
(95% confidence interval [CI])
(95% confidence interval [CI])
Patients gaining ≥ 15 letters (3 lines) in BVCA (n)
19.5% (64)
10.7% (35)
8.8% (3.4%, 14.3%)
Patients losing ≥ 15 letters in BVCA (n)
13.7% (45)
10.7% (35)
3.0% (-2.0%, 8.1%)
Mean change in BVCA (letters) (SDa)
2.2 (15.88)
0.8 (12.72)
1.3 (-0.9, 3.4)
aStandard deviation.
Primary Endpoint: Percentage of Patients With ≥ 15-Letter (3-Line) Gains in BCVA
From Baseline1
Pooled results of all DME randomized patients with LOCF from 2 multicenter, masked,
randomized, sham-controlled studies. The primary endpoint was the proportion of
patients with 15 or more letters’ improvement in BCVA from baseline at month 39
or final visit for subjects who exited the study at or prior to month 36. The month
39 extension was included to accommodate the evaluation of safety and efficacy outcomes
for subjects who received retreatment at month 36. Only 14% of the study patients
completed the month 39 visit (16.8% from OZURDEX® and 12.2%
from sham).4,9
Efficacy in pseudophakic patients
- OZURDEX® demonstrated BCVA improvement from baseline1,4
Pseudophakic Patients: Visual Acuity Outcomes at Month 391,4
Measurement
OZURDEX®
(n = 82)
(n = 82)
Sham
(n = 99)
(n = 99)
Estimated difference
(95% confidence interval [CI])
(95% confidence interval [CI])
Patients gaining ≥ 15 letters (3 lines) in BVCA (n)
20% (16)
11% (11)
8.4% (-2.2%, 19.0%)
Patients losing ≥ 15 letters in BVCA (n)
5% (4)
7% (7)
-2.2% (-9.1%, 4.7%)
Mean change in BVCA (letters) (SD)
5.8 (11.6)
1.4 (12.3)
4.2 (0.8, 7.6)
Pseudophakic Patients: Mean Change in BCVA From Baseline1
Pooled results from 2 multicenter, masked, randomized, sham-controlled, 3-year studies
in patients with DME. Subgroup for pooled data with LOCF. BCVA was measured using
a standard Early Treatment Diabetic Retinopathy Study (ETDRS) protocol.4,9
Efficacy in Phakic patients
Phakic Patients: Visual Acuity Outcomes at Month 391,4
Measurement
OZURDEX®
(n = 246)
(n = 246)
Sham
(n = 229)
(n = 229)
Estimated difference
(95% confidence interval [CI])
(95% confidence interval [CI])
Patients gaining ≥ 15 letters (3 lines) in BVCA (n)
20% (48)
11% (24)
9.0% (2.7%, 15.4%)
Patients losing ≥ 15 letters in BVCA (n)
17% (41)
12% (28)
4.4% (-1.9%, 10.7%)
Mean change in BVCA (letters) (SD)
1.0 (16.9)
0.6 (12.9)
0.3 (-2.4, 3.0)
Phakic Patients: Mean Change in BCVA From Baseline1
Pooled results of all phakic DME randomized patients with LOCF from 2 multicenter,
masked, randomized, sham-controlled studies. The primary endpoint was the proportion
of patients with 15 or more letters' improvement in BCVA from baseline at month
39 or final visit for subjects who exited the study at or prior to month 36. The
month 39 extension was included to accommodate the evaluation of safety and efficacy
outcomes for subjects who received retreatment at month 36. Only 14% of the study
patients completed the month 39 visit (16.8% from OZURDEX®
and 12.2% from sham).4,9
- 68% of phakic OZURDEX® patients (n = 243) experienced a cataract versus 21% of sham patients (n = 230) 4
- The occurrence of cataracts impacted visual acuity during the study4
Patients Who Were Phakic at Baseline: Mean Average Change in BCVA by
Change in Lens Status1
Post Hoc Analysis
Pooled results from 2 multicenter, masked, randomized, sham-controlled, 3-year trials
in patients with DME. Subgroup pooled data with LOCF. BCVA was measured using a
standard ETDRS protocol.4,9
