Trial Outcomes & Findings for Retrospective Data Collection Study in Patients Receiving Two or More OZURDEX® Injections for Macular Oedema Secondary to Retinal Vein Occlusion (NCT NCT01566526)

Results Overview

The time interval is measured from the first OZURDEX® injection to the second OZURDEX® injection in the study eye.

Recruitment status

COMPLETED

Target enrollment

26 participants

Primary outcome timeframe

Up to 12 Months

Results posted on

2013-05-27

Participant Flow

Participant milestones

Participant milestones
Measure	Patients Previously Treated With OZURDEX® OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
Overall Study STARTED	26
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Retrospective Data Collection Study in Patients Receiving Two or More OZURDEX® Injections for Macular Oedema Secondary to Retinal Vein Occlusion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Previously Treated With OZURDEX® n=26 Participants OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
Age, Customized 41 to 50 years	3 Participants n=5 Participants
Age, Customized 51 to 60 years	10 Participants n=5 Participants
Age, Customized 61 to 70 years	4 Participants n=5 Participants
Age, Customized 71 to 80 years	8 Participants n=5 Participants
Age, Customized 81 to 90 years	1 Participants n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 Months

Population: All enrolled patients.

The time interval is measured from the first OZURDEX® injection to the second OZURDEX® injection in the study eye.

Outcome measures

Outcome measures
Measure	Patients Previously Treated With OZURDEX® n=26 Participants OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
Time to OZURDEX® Re-Injection in the Study Eye	143.65 Days Standard Deviation 42.95

SECONDARY outcome

Timeframe: Baseline, 7 to 12 weeks following the last injection

Population: All enrolled patients with data for this data point.

BCVA is measured in the study eye following each injection of OZURDEX® using a special 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 improvement in the number of letters read means that the vision has improved. Data are reported for the 7-12 week period following the last injection.

Outcome measures

Outcome measures
Measure	Patients Previously Treated With OZURDEX® n=4 Participants OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following Last Injection in the Study Eye Baseline	61.75 Letters Standard Deviation 29.02
Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following Last Injection in the Study Eye Change from Baseline 7-12 Wks After Last Injection	-5.00 Letters Standard Deviation 45.28

SECONDARY outcome

Timeframe: Baseline, Up to 12 Months

Population: All enrolled patients with data for this data point.

BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 2 lines or more indicates an improvement.

Outcome measures

Outcome measures
Measure	Patients Previously Treated With OZURDEX® n=26 Participants OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
Percentage of Patients With an Increase of 2 Lines or More in BCVA From Baseline in the Study Eye	50.0 Percent of Participants

SECONDARY outcome

Timeframe: Baseline, Up to 12 Months

Population: All enrolled patients with data for this data point.

BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 3 lines or more indicates an improvement.

Outcome measures

Outcome measures
Measure	Patients Previously Treated With OZURDEX® n=26 Participants OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
Percentage of Patients With an Increase of 3 Lines or More in BCVA From Baseline in the Study Eye	42.3 Percent of Participants

SECONDARY outcome

Timeframe: Baseline, 7 to 12 weeks following the last injection

Population: All enrolled patients with data for this data point.

OCT is measured in the study eye following each injection of OZURDEX®. OCT is a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicates an improvement. Data are reported for the 7-12 week period following the last injection.

Outcome measures

Outcome measures
Measure	Patients Previously Treated With OZURDEX® n=6 Participants OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
Change From Baseline in Central Retinal Thickness in the Study Eye by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following Last Injection Baseline	665.00 Micrometers (µm) Standard Deviation 287.84
Change From Baseline in Central Retinal Thickness in the Study Eye by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following Last Injection Change from Baseline 7-12 Wks After Last Injection	-382.17 Micrometers (µm) Standard Deviation 285.36

SECONDARY outcome

Timeframe: Baseline, Up to 12 Months

Population: All enrolled patients with data for this data point who had an improvement of ≥ 2 lines in BCVA.

BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 2 lines or more indicates an improvement.

Outcome measures

Outcome measures
Measure	Patients Previously Treated With OZURDEX® n=13 Participants OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
Time to Improvement of 2 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye	41.0 Days Full Range 41.49 • Interval 25.0 to 154.0

SECONDARY outcome

Timeframe: Baseline, Up to 12 Months

Population: All enrolled patients with data for this data point who had an improvement of ≥ 3 lines in BCVA.

BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 3 lines or more indicates an improvement.

Outcome measures

Outcome measures
Measure	Patients Previously Treated With OZURDEX® n=11 Participants OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
Time to Improvement of 3 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye	41.0 Days Full Range 45.46 • Interval 25.0 to 154.0

Adverse Events

Patients Previously Treated With OZURDEX®

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Patients Previously Treated With OZURDEX® n=26 participants at risk OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
Eye disorders Lenticular Opacities	19.2% 5/26 • All adverse events (AEs) related to study drug were collected from the time of the first OZURDEX® injection through six months after the last injection. All enrolled patients were used to assess adverse events (AEs) and serious adverse events (SAEs). This was a retrospective study. Patient charts were reviewed for AEs.
Eye disorders Ocular Hypertension	19.2% 5/26 • All adverse events (AEs) related to study drug were collected from the time of the first OZURDEX® injection through six months after the last injection. All enrolled patients were used to assess adverse events (AEs) and serious adverse events (SAEs). This was a retrospective study. Patient charts were reviewed for AEs.
Eye disorders Intraocular Pressure Increased	15.4% 4/26 • All adverse events (AEs) related to study drug were collected from the time of the first OZURDEX® injection through six months after the last injection. All enrolled patients were used to assess adverse events (AEs) and serious adverse events (SAEs). This was a retrospective study. Patient charts were reviewed for AEs.
Eye disorders Cataract	11.5% 3/26 • All adverse events (AEs) related to study drug were collected from the time of the first OZURDEX® injection through six months after the last injection. All enrolled patients were used to assess adverse events (AEs) and serious adverse events (SAEs). This was a retrospective study. Patient charts were reviewed for AEs.
Eye disorders Cataract Operation	11.5% 3/26 • All adverse events (AEs) related to study drug were collected from the time of the first OZURDEX® injection through six months after the last injection. All enrolled patients were used to assess adverse events (AEs) and serious adverse events (SAEs). This was a retrospective study. Patient charts were reviewed for AEs.
Eye disorders Eye Laser Surgery	11.5% 3/26 • All adverse events (AEs) related to study drug were collected from the time of the first OZURDEX® injection through six months after the last injection. All enrolled patients were used to assess adverse events (AEs) and serious adverse events (SAEs). This was a retrospective study. Patient charts were reviewed for AEs.
Eye disorders Macular Fibrosis	7.7% 2/26 • All adverse events (AEs) related to study drug were collected from the time of the first OZURDEX® injection through six months after the last injection. All enrolled patients were used to assess adverse events (AEs) and serious adverse events (SAEs). This was a retrospective study. Patient charts were reviewed for AEs.
Eye disorders Visual Impairment	7.7% 2/26 • All adverse events (AEs) related to study drug were collected from the time of the first OZURDEX® injection through six months after the last injection. All enrolled patients were used to assess adverse events (AEs) and serious adverse events (SAEs). This was a retrospective study. Patient charts were reviewed for AEs.

Additional Information

Vice President Medical Affairs,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

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