Trial Outcomes & Findings for A Retrospective Data Collection Study in Patients Receiving Dexamethasone Intravitreal Implant (Ozurdex®) for Macular Oedema Due to Retinal Vein Occlusion (RVO) (NCT NCT01445626)

Results Overview

Time to OZURDEX® re-injection is the time in days between the first and second OZURDEX® injections.

Recruitment status

COMPLETED

Target enrollment

87 participants

Primary outcome timeframe

Up to 12 months

Results posted on

2013-02-18

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
Overall Study STARTED	87
Overall Study COMPLETED	87
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Retrospective Data Collection Study in Patients Receiving Dexamethasone Intravitreal Implant (Ozurdex®) for Macular Oedema Due to Retinal Vein Occlusion (RVO)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=87 Participants Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
Age Continuous	68.48 Years STANDARD_DEVIATION 9.15 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 months

Population: All participants with data available for analysis.

Time to OZURDEX® re-injection is the time in days between the first and second OZURDEX® injections.

Outcome measures

Outcome measures
Measure	All Participants n=85 Participants Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
Time to OZURDEX® Re-injection	140.80 Days Standard Deviation 56.65 • Interval 28.0 to 323.0

SECONDARY outcome

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

Population: All participants with data available for analysis.

BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of letters ranging from 0 (worse) to 100 (best). The change in BCVA was calculated using the most improved number of letters read correctly between 7 and 12 weeks following the last injection of OZURDEX® - the number of letters read correctly at baseline. A positive change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	All Participants n=35 Participants Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following the Last Injection Baseline	50.97 Letters Standard Deviation 18.82 • Interval 20.0 to 76.0
Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following the Last Injection Change from baseline 7-12 wks after last injection	10.89 Letters Standard Deviation 21.21 • Interval -41.0 to 45.0

SECONDARY outcome

Timeframe: Baseline, Up to 12 months

Population: All treated participants.

BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) 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=87 Participants Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
Percentage of Patients With an Increase of 2 Lines or More in BCVA	56.3 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Up to 12 months

Population: All treated participants.

BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) 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=87 Participants Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
Percentage of Patients With an Increase of 3 Lines or More in BCVA	50.6 Percentage of participants

SECONDARY outcome

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

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 7 to 12 weeks after the last injection. A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	All Participants n=34 Participants Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following the Last Injection Baseline	576.85 µm Standard Deviation 204.66
Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following the Last Injection Change from baseline 7-12 wks after last injection	-259.21 µm Standard Deviation 265.35

SECONDARY outcome

Timeframe: Baseline, Up to 12 months

Population: All participants with data available for analysis.

Time to improvement of 2 lines or more in BCVA is defined as the number of days after the first injection of OZURDEX® to achieve an improvement of 2 or more lines read correctly compared to baseline. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best).

Outcome measures

Outcome measures
Measure	All Participants n=42 Participants Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
Time to Improvement of 2 Lines or More in BCVA	55.0 Days Interval 27.0 to 184.0

SECONDARY outcome

Timeframe: Baseline, Up to 12 months

Population: All participants with data available for analysis.

Time to improvement of 3 lines or more in BCVA is defined as the number of days after the first injection of OZURDEX® to achieve an improvement of 3 or more lines read correctly compared to baseline. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best).

Outcome measures

Outcome measures
Measure	All Participants n=35 Participants Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
Time to Improvement of 3 Lines or More in BCVA	57.0 Days Interval 27.0 to 208.0

Adverse Events

All Participants

Serious events: 6 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Participants n=87 participants at risk Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
Eye disorders Cataract operation	3.4% 3/87 This was a retrospective study. Patient charts were reviewed for adverse events (AEs). All AEs related to study drug were collected from the time of the first OZURDEX® injection through six months after the last injection.
Eye disorders Suspected glaucoma	1.1% 1/87 This was a retrospective study. Patient charts were reviewed for adverse events (AEs). All AEs related to study drug were collected from the time of the first OZURDEX® injection through six months after the last injection.
Eye disorders Choroidal detachment	1.1% 1/87 This was a retrospective study. Patient charts were reviewed for adverse events (AEs). All AEs related to study drug were collected from the time of the first OZURDEX® injection through six months after the last injection.
Eye disorders Cataract progression	1.1% 1/87 This was a retrospective study. Patient charts were reviewed for adverse events (AEs). All AEs related to study drug were collected from the time of the first OZURDEX® injection through six months after the last injection.

Other adverse events

Other adverse events
Measure	All Participants n=87 participants at risk Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
Investigations Intraocular pressure increased	18.4% 16/87 This was a retrospective study. Patient charts were reviewed for adverse events (AEs). All AEs related to study drug were collected from the time of the first OZURDEX® injection through six months after the last injection.
Eye disorders Glaucoma	11.5% 10/87 This was a retrospective study. Patient charts were reviewed for adverse events (AEs). All AEs related to study drug were collected from the time of the first OZURDEX® injection through six months after the last injection.
Eye disorders Eye laser surgery	10.3% 9/87 This was a retrospective study. Patient charts were reviewed for adverse events (AEs). All AEs related to study drug were collected from the time of the first OZURDEX® injection through six months after the last injection.
Eye disorders Cataract operation	6.9% 6/87 This was a retrospective study. Patient charts were reviewed for adverse events (AEs). All AEs related to study drug were collected from the time of the first OZURDEX® injection through six months after the last injection.
Eye disorders Retinal degeneration	6.9% 6/87 This was a retrospective study. Patient charts were reviewed for adverse events (AEs). All AEs related to study drug were collected from the time of the first OZURDEX® injection through six months after the last injection.

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