Trial Outcomes & Findings for Study of Ozurdex® Treatment Practice in Patients With Macular Oedema Due to Retinal Vein Occlusion (NCT NCT01618266)
NCT ID: NCT01618266
Last Updated: 2016-03-14
Results Overview
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.
COMPLETED
375 participants
Baseline, Month 6
2016-03-14
Participant Flow
Participant milestones
| Measure |
Ozurdex® (Dexamethasone Intravitreal Implant)
dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
|
|---|---|
|
Overall Study
STARTED
|
375
|
|
Overall Study
COMPLETED
|
279
|
|
Overall Study
NOT COMPLETED
|
96
|
Reasons for withdrawal
| Measure |
Ozurdex® (Dexamethasone Intravitreal Implant)
dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
|
Overall Study
Treatment satisfaction
|
10
|
|
Overall Study
Other reasons
|
11
|
|
Overall Study
Lack of Efficacy
|
23
|
|
Overall Study
Protocol Violation
|
43
|
Baseline Characteristics
Study of Ozurdex® Treatment Practice in Patients With Macular Oedema Due to Retinal Vein Occlusion
Baseline characteristics by cohort
| Measure |
Ozurdex® (Dexamethasone Intravitreal Implant)
n=375 Participants
dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
|
|---|---|
|
Age, Continuous
|
70.31 Years
STANDARD_DEVIATION 11.19 • n=5 Participants
|
|
Sex: Female, Male
Female
|
169 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
206 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: All enrolled 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.
Outcome measures
| Measure |
Ozurdex® (Dexamethasone Intravitreal Implant)
n=375 Participants
dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
|
|---|---|
|
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Baseline
|
47.56 Letters
Standard Deviation 21.21
|
|
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 outcome
Timeframe: Baseline, Month 6Population: All enrolled patients with 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.
Outcome measures
| Measure |
Ozurdex® (Dexamethasone Intravitreal Implant)
n=202 Participants
dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
|
|---|---|
|
Change From Baseline in BCVA in the Study Eye Diagnosed With Branch Retinal Vein Occlusion (BRVO)
Baseline
|
52.80 Letters
Standard Deviation 17.42
|
|
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 outcome
Timeframe: Baseline, Month 6Population: All enrolled patients with 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.
Outcome measures
| Measure |
Ozurdex® (Dexamethasone Intravitreal Implant)
n=173 Participants
dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
|
|---|---|
|
Change From Baseline in BCVA in the Study Eye Diagnosed With Central Retinal Vein Occlusion (CRVO)
Baseline
|
41.45 Letters
Standard Deviation 23.54
|
|
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 outcome
Timeframe: Baseline, Month 6Population: All enrolled patients who were treatment naïve
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.
Outcome measures
| Measure |
Ozurdex® (Dexamethasone Intravitreal Implant)
n=145 Participants
dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
|
|---|---|
|
Change From Baseline in BCVA in the Study Eye in Previously Treatment Naïve Patients
Baseline
|
43.94 Letters
Standard Deviation 23.12
|
|
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 20.00
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: All enrolled 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®.
Outcome measures
| Measure |
Ozurdex® (Dexamethasone Intravitreal Implant)
n=149 Participants
dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
|
|---|---|
|
Change From Baseline in BCVA in the Study Eye in Patients Previously Treated With Ozurdex®
Baseline
|
52.46 Letters
Standard Deviation 18.90
|
|
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 outcome
Timeframe: Baseline, Month 6Population: All enrolled 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.
Outcome measures
| Measure |
Ozurdex® (Dexamethasone Intravitreal Implant)
n=79 Participants
dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
|
|---|---|
|
Change From Baseline in BCVA in the Study Eye in Patients Previously Naïve to Ozurdex® Treatment
Baseline
|
45.29 Letters
Standard Deviation 20.20
|
|
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 21.10
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: All enrolled patients with 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.
Outcome measures
| Measure |
Ozurdex® (Dexamethasone Intravitreal Implant)
n=180 Participants
dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
|
|---|---|
|
Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset <3 Months
Baseline
|
43.27 Letters
Standard Deviation 22.83
|
|
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 20.50
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: All enrolled patients with 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.
Outcome measures
| Measure |
Ozurdex® (Dexamethasone Intravitreal Implant)
n=183 Participants
dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
|
|---|---|
|
Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset ≥3 Months
Baseline
|
51.44 Letters
Standard Deviation 19.00
|
|
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 outcome
Timeframe: Baseline, Month 6Population: All enrolled 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®.
Outcome measures
| Measure |
Ozurdex® (Dexamethasone Intravitreal Implant)
n=254 Participants
dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
|
|---|---|
|
Change From Baseline in BCVA in the Study Eye in Patients Only Treated With Ozurdex®
Baseline
|
49.28 Letters
Standard Deviation 19.23
|
|
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 outcome
Timeframe: Baseline, Month 6Population: All enrolled 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.
Outcome measures
| Measure |
Ozurdex® (Dexamethasone Intravitreal Implant)
n=121 Participants
dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: Baseline, Week 6, Month 4, Month 12, Month 18, Month 24Population: All enrolled 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.
Outcome measures
| Measure |
Ozurdex® (Dexamethasone Intravitreal Implant)
n=375 Participants
dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
|
|---|---|
|
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Baseline
|
47.6 Letters
Standard Deviation 21.2
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: Baseline, Month 24Population: All enrolled 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). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.
Outcome measures
| Measure |
Ozurdex® (Dexamethasone Intravitreal Implant)
n=375 Participants
dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
|
|---|---|
|
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye
|
38.7 Percentage of Patients
|
Adverse Events
Ozurdex® (Dexamethasone Intravitreal Implant)
Serious adverse events
| Measure |
Ozurdex® (Dexamethasone Intravitreal Implant)
n=375 participants at risk
dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
|
|---|---|
|
Eye disorders
Ocular Hypertension
|
8.5%
32/375
|
|
Eye disorders
Cataract
|
6.9%
26/375
|
|
Eye disorders
Glaucoma
|
1.6%
6/375
|
|
Surgical and medical procedures
Cataract Surgery
|
0.80%
3/375
|
|
Eye disorders
Vitreous Haemorrhage
|
0.80%
3/375
|
|
Nervous system disorders
Stroke
|
0.53%
2/375
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.53%
2/375
|
|
Eye disorders
Macular Fibrosis
|
0.53%
2/375
|
|
General disorders
Death
|
0.53%
2/375
|
|
Cardiac disorders
Cardiac Arrest
|
0.27%
1/375
|
|
Eye disorders
Subscapular Cataract
|
0.27%
1/375
|
|
Nervous system disorders
Sudden Falls Due to Legs Giving Way
|
0.27%
1/375
|
|
Metabolism and nutrition disorders
Diabetes
|
0.27%
1/375
|
|
Eye disorders
Detached Retina
|
0.27%
1/375
|
|
Cardiac disorders
Cardiopulmonary Arrest
|
0.27%
1/375
|
|
Eye disorders
Macular Degeneration
|
0.27%
1/375
|
|
Vascular disorders
Hypertension
|
0.27%
1/375
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.49%
1/206
|
|
Vascular disorders
Infarction
|
0.27%
1/375
|
|
Infections and infestations
Pulmonary Infection
|
0.27%
1/375
|
|
Eye disorders
Retinal Ischaemia
|
0.27%
1/375
|
|
Infections and infestations
Herpetic Keratitis
|
0.27%
1/375
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.27%
1/375
|
|
Gastrointestinal disorders
Acute Pancreatitis
|
0.27%
1/375
|
|
Surgical and medical procedures
Coronary Artery Bypass
|
0.27%
1/375
|
|
Vascular disorders
Pulmonary Arterial Thrombosis
|
0.27%
1/375
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Disorder
|
0.27%
1/375
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate tumour
|
0.49%
1/206
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.27%
1/375
|
Other adverse events
| Measure |
Ozurdex® (Dexamethasone Intravitreal Implant)
n=375 participants at risk
dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
|
|---|---|
|
Eye disorders
Ocular Hypertension
|
34.1%
128/375
|
|
Eye disorders
Cataract
|
33.1%
124/375
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER