Trial Outcomes & Findings for Chart Review: Drug Utilization Study in Participants Who Received Ozurdex™ (Dexamethasone Intravitreal Implant) 0.7 mg Injections for Visual Impairment Due to Diabetic Macular Edema (DME) (NCT NCT03889444)

Results Overview

Study eye was defined as the eye that received the most OZURDEX® injections.

Recruitment status

COMPLETED

Target enrollment

141 participants

Primary outcome timeframe

Up to 44 months

Results posted on

2020-06-22

Participant Flow

Participant milestones

Participant milestones
Measure	OZURDEX® Participants with diabetic macular edema prescribed dexamethasone intravitreal implant, 0.7 mg (OZURDEX®) as per routine clinical practice.
Overall Study STARTED	141
Overall Study COMPLETED	141
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OZURDEX® n=141 Participants Participants with diabetic macular edema prescribed dexamethasone intravitreal implant, 0.7 mg (OZURDEX®) as per routine clinical practice.
Age, Continuous	65.7 years n=141 Participants
Sex: Female, Male Female	57 Participants n=141 Participants
Sex: Female, Male Male	84 Participants n=141 Participants

PRIMARY outcome

Timeframe: Up to 44 months

Population: Analysis Population included all selected participants for whom an eCRF has been completed and who met selection criteria.

Study eye was defined as the eye that received the most OZURDEX® injections.

Outcome measures

Outcome measures
Measure	OZURDEX® n=141 Participants Participants with diabetic macular edema prescribed dexamethasone intravitreal implant, 0.7 mg (OZURDEX®) as per routine clinical practice.
Mean Number of OZURDEX® Implant Reinjections in the Study Eye	3.0 number of injections Standard Deviation 1.9

PRIMARY outcome

Timeframe: Up to 44 months

Population: Analysis Population included all selected participants for whom an eCRF has been completed and who met selection criteria.

The time to reinjection is defined as the time in months from the date of one OZURDEX® injection to the subsequent OZURDEX® injection.

Outcome measures

Outcome measures
Measure	OZURDEX® n=141 Participants Participants with diabetic macular edema prescribed dexamethasone intravitreal implant, 0.7 mg (OZURDEX®) as per routine clinical practice.
Time to OZURDEX® Reinjection	5.7 months Standard Deviation 4.2

SECONDARY outcome

Timeframe: Last assessment prior to each OZURDEX® injection, 7 to 12 weeks following each injection

Population: Analysis Population included all selected participants for whom an eCRF has been completed and who met selection criteria. Number analyzed is the number of participants with evaluable data at the given time-point.

BCVA is measured in the study eye (defined as the eye that received the most OZURDEX® injections) following each injection of OZURDEX® using a special eye chart and is reported as 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. The higher the number of letters read correctly, the better the vision. A positive number indicates improvement. Change data are reported for each injection relative to the assessment immediately prior to the injection to 7 to 12 weeks following that injection.

Outcome measures

Outcome measures
Measure	OZURDEX® n=141 Participants Participants with diabetic macular edema prescribed dexamethasone intravitreal implant, 0.7 mg (OZURDEX®) as per routine clinical practice.
Change in Best Corrected Visual Acuity (BCVA) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Before Injection 1 to 7-12 weeks After Injection 1	3.4 letters Standard Deviation 13.7
Change in Best Corrected Visual Acuity (BCVA) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Reinjection 1 to 7-12 weeks After Reinjection 1	1.2 letters Standard Deviation 12.4
Change in Best Corrected Visual Acuity (BCVA) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Reinjection 2 to 7-12 weeks After Reinjection 2	0.5 letters Standard Deviation 5.8
Change in Best Corrected Visual Acuity (BCVA) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Reinjection 3 to 7-12 weeks After Reinjection 3	3.2 letters Standard Deviation 8.0
Change in Best Corrected Visual Acuity (BCVA) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Reinjection 4 to 7-12 weeks After Reinjection 4	3.0 letters Standard Deviation 4.7
Change in Best Corrected Visual Acuity (BCVA) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Reinjection 5 to 7-12 weeks After Reinjection 5	0.1 letters Standard Deviation 4.7
Change in Best Corrected Visual Acuity (BCVA) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Reinjection 6 to 7-12 weeks After Reinjection 6	-0.3 letters Standard Deviation 0.6
Change in Best Corrected Visual Acuity (BCVA) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Reinjection 7 to 7-12 weeks After Reinjection 7	0.0 letters Standard Deviation NA Standard deviation (SD) was not estimable for one participant.
Change in Best Corrected Visual Acuity (BCVA) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Reinjection 8 to 7-12 weeks After Reinjection 8	6.3 letters Standard Deviation 8.8
Change in Best Corrected Visual Acuity (BCVA) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Reinjection 9 to 7-12 weeks After Reinjection 9	-0.5 letters Standard Deviation 0.7
Change in Best Corrected Visual Acuity (BCVA) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Reinjection 10 to 7-12 weeks After Reinjection 10	0.0 letters Standard Deviation 0.0

SECONDARY outcome

Timeframe: Baseline (Last assessment prior to the first OZURDEX® injection), 7 to 12 weeks following each injection

Population: Analysis Population included all selected participants for whom an eCRF has been completed and who met selection criteria. Number analyzed is the number of participants with evaluable data at the given time-point.

BCVA is measured in the study eye (defined as the eye that received the most OZURDEX® injections) following each injection of OZURDEX® using a special eye chart and is reported as 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. The higher the number of letters read correctly, the better the vision. A positive change from baseline indicates improvement. Change data are reported for each injection relative to the assessment prior the first injection to 7 to 12 weeks following each injection.

Outcome measures

Outcome measures
Measure	OZURDEX® n=141 Participants Participants with diabetic macular edema prescribed dexamethasone intravitreal implant, 0.7 mg (OZURDEX®) as per routine clinical practice.
Change From Baseline in BCVA From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Baseline to 7-12 weeks After Injection 1	3.4 letters Standard Deviation 13.7
Change From Baseline in BCVA From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Baseline to 7-12 weeks After Reinjection 1	3.7 letters Standard Deviation 10.0
Change From Baseline in BCVA From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Baseline to 7-12 weeks After Reinjection 2	3.2 letters Standard Deviation 10.9
Change From Baseline in BCVA From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Baseline to 7-12 weeks After Reinjection 3	-1.4 letters Standard Deviation 12.5
Change From Baseline in BCVA From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Baseline to 7-12 weeks After Reinjection 4	0.5 letters Standard Deviation 18.6
Change From Baseline in BCVA From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Baseline to 7-12 weeks After Reinjection 5	3.5 letters Standard Deviation 15.4
Change From Baseline in BCVA From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Baseline to 7-12 weeks After Reinjection 6	5.1 letters Standard Deviation 8.2
Change From Baseline in BCVA From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Baseline to 7-12 weeks After Reinjection 7	0.0 letters Standard Deviation 0.0
Change From Baseline in BCVA From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Baseline to 7-12 weeks After Reinjection 8	-0.8 letters Standard Deviation 3.8
Change From Baseline in BCVA From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Baseline to 7-12 weeks After Reinjection 9	-3.7 letters Standard Deviation 3.2
Change From Baseline in BCVA From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Baseline to 7-12 weeks After Reinjection 10	-0.3 letters Standard Deviation 4.5

SECONDARY outcome

Timeframe: Last assessment prior to each OZURDEX® injection, 7 to 12 weeks following each injection

Population: Analysis Population included all selected participants for whom an eCRF has been completed and who met selection criteria. Number analyzed is the number of participants with evaluable data at the given time-point.

OCT is measured in the study eye (defined as the eye that received the most OZURDEX® injections) prior to and 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. Change data are reported for each injection relative to the assessment immediately prior to the injection to 7 to 12 weeks following that injection.

Outcome measures

Outcome measures
Measure	OZURDEX® n=141 Participants Participants with diabetic macular edema prescribed dexamethasone intravitreal implant, 0.7 mg (OZURDEX®) as per routine clinical practice.
Change in Central Retinal Thickness (CRT) by Optical Coherence Tomography (OCT) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Before Injection 1 to 7-12 weeks After Injection 1	-88.3 micrometer (μm) Standard Deviation 100.2
Change in Central Retinal Thickness (CRT) by Optical Coherence Tomography (OCT) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Reinjection 1 to 7-12 weeks After Reinjection 1	-63.9 micrometer (μm) Standard Deviation 79.6
Change in Central Retinal Thickness (CRT) by Optical Coherence Tomography (OCT) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Reinjection 2 to 7-12 weeks After Reinjection 2	-70.4 micrometer (μm) Standard Deviation 96.4
Change in Central Retinal Thickness (CRT) by Optical Coherence Tomography (OCT) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Reinjection 3 to 7-12 weeks After Reinjection 3	-51.6 micrometer (μm) Standard Deviation 54.4
Change in Central Retinal Thickness (CRT) by Optical Coherence Tomography (OCT) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Reinjection 4 to 7-12 weeks After Reinjection 4	-84.0 micrometer (μm) Standard Deviation 94.4
Change in Central Retinal Thickness (CRT) by Optical Coherence Tomography (OCT) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Reinjection 5 to 7-12 weeks After Reinjection 5	-60.6 micrometer (μm) Standard Deviation 44.2
Change in Central Retinal Thickness (CRT) by Optical Coherence Tomography (OCT) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Reinjection 6 to 7-12 weeks After Reinjection 6	-68.3 micrometer (μm) Standard Deviation 93.9
Change in Central Retinal Thickness (CRT) by Optical Coherence Tomography (OCT) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Reinjection 7 to 7-12 weeks After Reinjection 7	-3.0 micrometer (μm) Standard Deviation NA SD was not estimable for one participant.
Change in Central Retinal Thickness (CRT) by Optical Coherence Tomography (OCT) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Reinjection 8 to 7-12 weeks After Reinjection 8	-70.0 micrometer (μm) Standard Deviation NA SD was not estimable for one participant.
Change in Central Retinal Thickness (CRT) by Optical Coherence Tomography (OCT) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Reinjection 9 to 7-12 weeks After Reinjection 9	-55.5 micrometer (μm) Standard Deviation 4.9
Change in Central Retinal Thickness (CRT) by Optical Coherence Tomography (OCT) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Reinjection 10 to 7-12 weeks After Reinjection 10	-15.0 micrometer (μm) Standard Deviation 2.8

SECONDARY outcome

Timeframe: Baseline (Last assessment prior to the first OZURDEX® injection), 7 to 12 weeks following each injection

Population: Analysis Population included all selected participants for whom an eCRF has been completed and who met selection criteria. Number analyzed is the number of participants with evaluable data at the given time-point.

OCT is measured at Baseline and following each injection of OZURDEX® in the study eye (defined as the eye that received the most OZURDEX® injections . 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. Change data are reported for each injection relative to the assessment prior the first injection to 7 to 12 weeks following each injection.

Outcome measures

Outcome measures
Measure	OZURDEX® n=141 Participants Participants with diabetic macular edema prescribed dexamethasone intravitreal implant, 0.7 mg (OZURDEX®) as per routine clinical practice.
Change From Baseline in CRT by OCT From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Baseline to 7-12 weeks After Injection 1	-88.3 μm Standard Deviation 100.2
Change From Baseline in CRT by OCT From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Baseline to 7-12 weeks After Reinjection 1	-81.6 μm Standard Deviation 97.5
Change From Baseline in CRT by OCT From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Baseline to 7-12 weeks After Reinjection 2	-102.4 μm Standard Deviation 117.6
Change From Baseline in CRT by OCT From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Baseline to 7-12 weeks After Reinjection 3	-124.1 μm Standard Deviation 165.1
Change From Baseline in CRT by OCT From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Baseline to 7-12 weeks After Reinjection 4	-115.7 μm Standard Deviation 135.6
Change From Baseline in CRT by OCT From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Baseline to 7-12 weeks After Reinjection 5	-147.7 μm Standard Deviation 152.6
Change From Baseline in CRT by OCT From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Baseline to 7-12 weeks After Reinjection 6	-167.3 μm Standard Deviation 244.4
Change From Baseline in CRT by OCT From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Baseline to 7-12 weeks After Reinjection 7	-35.3 μm Standard Deviation 29.0
Change From Baseline in CRT by OCT From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Baseline to 7-12 weeks After Reinjection 8	-22.5 μm Standard Deviation 6.4
Change From Baseline in CRT by OCT From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Baseline to 7-12 weeks After Reinjection 9	-19.3 μm Standard Deviation 91.6
Change From Baseline in CRT by OCT From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection Baseline to 7-12 weeks After Reinjection 10	-42.3 μm Standard Deviation 62.1

SECONDARY outcome

Timeframe: Up to 44 months

Population: Analysis Population included all selected participants for whom an eCRF has been completed and who met selection criteria.

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. The adverse events of special interest include: Glaucoma, defined as damage to the optic nerve with progressive vision loss, Intraocular hypertension, defined as intra-ocular pressure (IOP) without meeting the criteria for glaucoma, Hypotony, defined as low IOP ≤5 mmHg, Cataract or lens opacities, Ocular bleeding or hemorrhage, Retinal detachment, tear or hole, Vitreous detachment, Infection vs. Non-infection related Ocular inflammation, Significant vitreous loss, Mechanical failure of device and implant misplacement, Implant dislocation.

Outcome measures

Outcome measures
Measure	OZURDEX® n=141 Participants Participants with diabetic macular edema prescribed dexamethasone intravitreal implant, 0.7 mg (OZURDEX®) as per routine clinical practice.
Percentage of Participants Who Experienced At Least One Adverse Events of Special Interest (AESIs)	18.4 percentage of participants

Adverse Events

OZURDEX®

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	OZURDEX® n=141 participants at risk Participants with diabetic macular edema prescribed dexamethasone intravitreal implant, 0.7 mg (OZURDEX®) as per routine clinical practice.
Eye disorders Intraocular hypertension	6.4% 9/141 • Up to 44 months Only adverse events of special interest were collected during the study.
Eye disorders Cataract or lens opacities	5.0% 7/141 • Up to 44 months Only adverse events of special interest were collected during the study.

Additional Information

Therapeutic Area, Head

Allergan

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