Trial Outcomes & Findings for Safety and Efficacy of Dexamethasone (OZURDEX®) Intravitreal Implant in Korea (NCT NCT01976650)

Results Overview

An Adverse Event is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction is a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded.

Recruitment status

COMPLETED

Target enrollment

724 participants

Primary outcome timeframe

4 Years

Results posted on

2016-01-13

Participant Flow

The Enrolled Population includes all 724 patients consented. The Safety Analysis Population includes 718 patients who were treated per protocol and completed a survey. The Safety Analysis Population was used for all analyses.

Participant milestones

Participant milestones
Measure	OZURDEX® Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.
Overall Study STARTED	724
Overall Study COMPLETED	718
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of Dexamethasone (OZURDEX®) Intravitreal Implant in Korea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OZURDEX® n=718 Participants Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.
Age, Continuous	62.18 Years STANDARD_DEVIATION 11.14 • n=5 Participants
Sex: Female, Male Female	424 Participants n=5 Participants
Sex: Female, Male Male	294 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 Years

Population: Safety Population: all patients who were treated per protocol and completed a survey

An Adverse Event is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction is a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded.

Outcome measures

Outcome measures
Measure	OZURDEX® n=718 Participants Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.
Number of Patients With Adverse Events or Adverse Drug Reactions Adverse Events	55 Patients
Number of Patients With Adverse Events or Adverse Drug Reactions Adverse Drug Reactions	50 Patients

SECONDARY outcome

Timeframe: 4 Years

Population: Efficacy Population: all patients who were treated per protocol who had data available for analysis

BCVA is measured using an eye chart and is reported as the 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 (or visual acuity). An increase in the number of letters read correctly means that vision has improved and was considered 'effective'. The percentage of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.

Outcome measures

Outcome measures
Measure	OZURDEX® n=691 Participants Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.
Percentage of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye	94.36 Percentage of Participants

Adverse Events

OZURDEX®

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	OZURDEX® n=718 participants at risk Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.
Eye disorders Ocular Tension Decreased	0.14% 1/718 The Safety Analysis Population includes patients treated with dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant and completed a survey. The Safety Analysis Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
Eye disorders Endophthalmitis	0.28% 2/718 The Safety Analysis Population includes patients treated with dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant and completed a survey. The Safety Analysis Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
Eye disorders Macula Lutea	0.14% 1/718 The Safety Analysis Population includes patients treated with dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant and completed a survey. The Safety Analysis Population was used to assess adverse events (AEs) and serious adverse events (SAEs).

Other adverse events

Adverse event data not reported

Additional Information

Therapeutic Area Head,

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