Trial Outcomes & Findings for Retrospective Data Collection Study in Patients With Macular Oedema Receiving OZURDEX® (NCT NCT02181530)

Results Overview

BCVA is measured in the study eye following each injection of OZURDEX® using a special eye chart. The number of letters read correctly Snellen fraction are converted to a decimal scale. There are 11 lines on a standard Snellen chart ranging from 0.1 (20/200) at worst to 2.0 (20/10) at best. 20/20 on the decimal scale is equal to 1.0. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). The higher the number of letters read correctly (higher number on the decimal scale), the better the vision (or visual acuity). A positive number improvement in the number of letters read means that the vision has improved.

Recruitment status

COMPLETED

Target enrollment

43 participants

Primary outcome timeframe

Baseline, 7 to 12 weeks following the first OZURDEX® injection

Results posted on

2015-05-25

Participant Flow

Participant milestones

Participant milestones
Measure	OZURDEX® Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
Overall Study STARTED	43
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Retrospective Data Collection Study in Patients With Macular Oedema Receiving OZURDEX®

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OZURDEX® n=43 Participants Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
Age, Continuous	59.02 years STANDARD_DEVIATION 13.58 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 7 to 12 weeks following the first OZURDEX® injection

Population: All participants with data available at the time-point.

BCVA is measured in the study eye following each injection of OZURDEX® using a special eye chart. The number of letters read correctly Snellen fraction are converted to a decimal scale. There are 11 lines on a standard Snellen chart ranging from 0.1 (20/200) at worst to 2.0 (20/10) at best. 20/20 on the decimal scale is equal to 1.0. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). The higher the number of letters read correctly (higher number on the decimal scale), the better the vision (or visual acuity). A positive number improvement in the number of letters read means that the vision has improved.

Outcome measures

Outcome measures
Measure	OZURDEX® n=43 Participants Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye Baseline	0.22 units on a scale Standard Deviation 0.22
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye Change from Baseline at 7 to 12 weeks (n=27)	0.18 units on a scale Standard Deviation 0.25

SECONDARY outcome

Timeframe: Baseline, Up to 17 Months

Population: All participants.

BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate Early Treatment Diabetic Retinopathy Study (ETDRS) letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as "approxETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. An increase of 2 lines or more indicates an improvement.

Outcome measures

Outcome measures
Measure	OZURDEX® n=43 Participants Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
Percentage of Patients With an Increase of 2 Lines or More in BCVA in the Study Eye	63 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Up to 17 Months

Population: All participants.

BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate ETDRS letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as "approxETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. An increase of 3 lines or more indicates an improvement.

Outcome measures

Outcome measures
Measure	OZURDEX® n=43 Participants Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
Percentage of Patients With an Increase of 3 Lines or More in BCVA in the Study Eye	53 percentage of participants

SECONDARY outcome

Timeframe: Baseline, 7 to 12 weeks following the first OZURDEX® injection

Population: All participants with data available at the given time-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

Outcome measures

Outcome measures
Measure	OZURDEX® n=43 Participants Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT) Baseline	695.12 μm Standard Deviation 212.71
Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT) Change from Baseline at 7 to 12 weeks (n=26)	-355.08 μm Standard Deviation 184.72

SECONDARY outcome

Timeframe: Baseline, Up to 17 Months

Population: All participants with improvement of 2 lines or more in BCVA.

BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate ETDRS letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as "approxETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. The time in days to improvement of 2 or more lines is reported.

Outcome measures

Outcome measures
Measure	OZURDEX® n=27 Participants Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
Time to Improvement of 2 Lines or More in BCVA in the Study Eye	105.41 days Standard Deviation 184.50

SECONDARY outcome

Timeframe: Baseline, Up to 17 Months

Population: All participants with improvement of 3 lines or more in BCVA.

BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate ETDRS letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as "approxETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. The time in days to improvement of 3 or more lines is reported.

Outcome measures

Outcome measures
Measure	OZURDEX® n=23 Participants Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
Time to Improvement of 3 Lines or More in BCVA in the Study Eye	100.48 days Standard Deviation 172.84

SECONDARY outcome

Timeframe: Up to 17 Months

Population: All participants who had OZURDEX® re-injection.

Outcome measures

Outcome measures
Measure	OZURDEX® n=7 Participants Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
Time to OZURDEX® Re-Injection in the Study Eye	223.00 days Standard Deviation 54.71

Adverse Events

OZURDEX®

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	OZURDEX® n=43 participants at risk Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
Investigations Increased intraocular pressure	27.9% 12/43
Eye disorders Ocular hypertension	11.6% 5/43
Eye disorders Conjunctival haemorrhage	25.6% 11/43
Eye disorders Chemosis	9.3% 4/43
Eye disorders Conjunctival hyperaemia	23.3% 10/43
Eye disorders Cortical/nuclear cataract	9.3% 4/43
Eye disorders Subcapsular cataract	4.7% 2/43
Eye disorders Vitreous floaters	4.7% 2/43
Eye disorders Eye pain	7.0% 3/43

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