Trial Outcomes & Findings for Retrospective Study in Patients Receiving Two or More OZURDEX® Injections for Retinal Vein Occlusion (RVO) (NCT NCT01411696)

Last Updated: 2013-04-16

Results Overview

BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). The change in BCVA was calculated using the most improved number of lines read correctly between 4 and 20 weeks following the last injection of OZURDEX® - the number of lines read correctly at baseline. A positive change from baseline indicates improvement.

Recruitment status

COMPLETED

Target enrollment

289 participants

Primary outcome timeframe

Baseline, 4 to 20 weeks after last injection (Up to 6 months)

Results posted on

2013-04-16

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
Overall Study STARTED	289
Overall Study COMPLETED	289
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Retrospective Study in Patients Receiving Two or More OZURDEX® Injections for Retinal Vein Occlusion (RVO)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=289 Participants Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
Age Continuous	71.9 Years STANDARD_DEVIATION 10.95 • n=5 Participants
Sex: Female, Male Female	166 Participants n=5 Participants
Sex: Female, Male Male	123 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 4 to 20 weeks after last injection (Up to 6 months)

Population: All participants with data available for analysis.

Outcome measures

Outcome measures
Measure	All Participants n=283 Participants Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
Change From Baseline in Best Corrected Visual Acuity (BCVA) 4 to 20 Weeks Following the Last OZURDEX® (Dexamethasone Intravitreal Implant) Injection Change from baseline at Week 4 to 20 (n=209)	1.0 Lines Full Range 3.51 • Interval -13.0 to 12.0
Change From Baseline in Best Corrected Visual Acuity (BCVA) 4 to 20 Weeks Following the Last OZURDEX® (Dexamethasone Intravitreal Implant) Injection Baseline	9.8 Lines Full Range 4.62 • Interval 0.0 to 18.0

SECONDARY outcome

Timeframe: Baseline, Up to 6 months

Population: All participants.

BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). An increase of 2 or more lines read correctly compared to baseline is an improvement.

Outcome measures

Outcome measures
Measure	All Participants n=289 Participants Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
Percentage of Participants With an Increase of 2 Lines or More in BCVA	62.9 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Up to 6 months

Population: All participants.

BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). An increase of 3 or more lines read correctly compared to baseline is an improvement.

Outcome measures

Outcome measures
Measure	All Participants n=289 Participants Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
Percentage of Participants With an Increase of 3 Lines or More in BCVA	48.1 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, 4 to 20 Weeks after Each injection (up to 6 months)

Population: All participants with data available for analysis.

Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at baseline and 4 to 20 weeks after each injection. A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	All Participants n=247 Participants Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection Change from baseline; third injection (n=128)	-160.9 Micron (μm) Standard Deviation 172.98
Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection Change from baseline; fifth injection (n=31)	-145.9 Micron (μm) Standard Deviation 171.27
Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection Change from baseline; fourth injection (n=67)	-155.5 Micron (μm) Standard Deviation 171.25
Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection Baseline	437.8 Micron (μm) Standard Deviation 181.7
Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection Change from baseline; first injection (n=242)	-170.8 Micron (μm) Standard Deviation 179.27
Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection Change from baseline; second injection (n=232)	-177.6 Micron (μm) Standard Deviation 185.21
Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection Change from baseline; sixth injection (n=16)	-193.4 Micron (μm) Standard Deviation 186.01
Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection Change from baseline; seventh injection (n=5)	-220.8 Micron (μm) Standard Deviation 241.88
Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection Change from baseline; eighth injection (n=1)	-75.0 Micron (μm) Standard Deviation NA No measure of dispersion can be calculated for n=1.
Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection Change from baseline; ninth injection (n=1)	-61.0 Micron (μm) Standard Deviation NA No measure of dispersion can be calculated for n=1.

Adverse Events

All Participants

Serious events: 7 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Participants n=289 participants at risk Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
Cardiac disorders Arrhythmia	0.35% 1/289 SAEs (serious adverse events) and AEs (adverse events) were collected retrospectively from chart data.
Cardiac disorders Atrial fibrillation	0.35% 1/289 SAEs (serious adverse events) and AEs (adverse events) were collected retrospectively from chart data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.35% 1/289 SAEs (serious adverse events) and AEs (adverse events) were collected retrospectively from chart data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.35% 1/289 SAEs (serious adverse events) and AEs (adverse events) were collected retrospectively from chart data.
Infections and infestations Pneumonia	0.35% 1/289 SAEs (serious adverse events) and AEs (adverse events) were collected retrospectively from chart data.
Investigations Heart rate irregular	0.35% 1/289 SAEs (serious adverse events) and AEs (adverse events) were collected retrospectively from chart data.
Respiratory, thoracic and mediastinal disorders Asthma	0.35% 1/289 SAEs (serious adverse events) and AEs (adverse events) were collected retrospectively from chart data.

Other adverse events

Other adverse events
Measure	All Participants n=289 participants at risk Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
Eye disorders Cataract	9.0% 26/289 SAEs (serious adverse events) and AEs (adverse events) were collected retrospectively from chart data.
Investigations Intraocular pressure increased	8.0% 23/289 SAEs (serious adverse events) and AEs (adverse events) were collected retrospectively from chart data.

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