Trial Outcomes & Findings for A Retrospective Chart Review of OZURDEX® in Patients With Macular Edema (NCT NCT01805323)

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 peak mean change in BCVA was calculated using the most improved number of lines read correctly between 2 and 26 weeks following the last available injection of OZURDEX® - the number of lines read correctly at Baseline. A positive change from Baseline indicated improvement.

Recruitment status

COMPLETED

Target enrollment

101 participants

Primary outcome timeframe

Baseline, 2 to 26 weeks (wks) following last injection (up to 6.5 months)

Results posted on

2019-04-17

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
Overall Study STARTED	101
Overall Study COMPLETED	101
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Retrospective Chart Review of OZURDEX® in Patients With Macular Edema

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=101 Participants Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
Age, Continuous	60.9 Years STANDARD_DEVIATION 14.8 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	66 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 2 to 26 weeks (wks) following last injection (up to 6.5 months)

Population: All participants with BCVA observations available following the last OZURDEX® injection from 2 to 26 weeks.

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 peak mean change in BCVA was calculated using the most improved number of lines read correctly between 2 and 26 weeks following the last available injection of OZURDEX® - the number of lines read correctly at Baseline. A positive change from Baseline indicated improvement.

Outcome measures

Outcome measures
Measure	All Participants n=90 Eyes Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
Peak Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Baseline	6.3 Lines Standard Error 0.3
Peak Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Change from Baseline 2-26 wks after last injection	1.4 Lines Standard Error 0.3

SECONDARY outcome

Timeframe: Baseline, 2 to 26 weeks following last injection (up to 6.5 months)

Population: All participants with CRT observations available following the last OZURDEX® injection from 2 to 26 weeks.

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. The peak mean change was the maximum change from Baseline in CRT at 2 to 26 weeks following the last available injection of OZURDEX®. A negative change from Baseline indicated improvement.

Outcome measures

Outcome measures
Measure	All Participants n=85 Eyes Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
Peak Mean Change From Baseline in Central Retinal Thickness (CRT) Baseline	474.4 microns (μm) Standard Error 18.2
Peak Mean Change From Baseline in Central Retinal Thickness (CRT) Change from Baseline 2-26 wks after last injection	-183.4 microns (μm) Standard Error 17.9

Adverse Events

All Participants

Serious events: 4 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Participants n=101 participants at risk Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
Eye disorders Endophthalmitis	0.99% 1/101
Eye disorders Uveitis	0.99% 1/101
Injury, poisoning and procedural complications Retinal detachment	0.99% 1/101
Surgical and medical procedures Retinal implant	0.99% 1/101

Other adverse events

Other adverse events
Measure	All Participants n=101 participants at risk Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
Investigations Intraocular pressure increased	18.8% 19/101
Eye disorders Cystoid macular oedema	5.9% 6/101

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