Trial Outcomes & Findings for A Safety and Efficacy Study to Assess OZURDEX® in Patients With Macular Oedema Secondary to Retinal Vein Occlusion (RVO) (NCT NCT01571557)

Results Overview

BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate Early Treatment Diabetic Retinopathy Study (ETDRS) letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are "approximate ETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). The higher the number of letters read correctly (higher number on the decimal scale), the better the vision (or visual acuity). A positive number change from baseline in the number of letters read means vision has improved and a negative number change from baseline means vision has worsened.

Recruitment status

COMPLETED

Target enrollment

573 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2019-04-19

Participant Flow

Participant milestones

Participant milestones
Measure	OZURDEX® OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
Overall Study STARTED	573
Overall Study COMPLETED	573
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Safety and Efficacy Study to Assess OZURDEX® in Patients With Macular Oedema Secondary to Retinal Vein Occlusion (RVO)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OZURDEX® n=573 Participants OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
Age, Customized 31 to 40 years	4 Participants n=5 Participants
Age, Customized 41 to 50 years	13 Participants n=5 Participants
Age, Customized 51 to 60 years	69 Participants n=5 Participants
Age, Customized 61 to 70 years	127 Participants n=5 Participants
Age, Customized 71 to 80 years	235 Participants n=5 Participants
Age, Customized 81 to 90 years	119 Participants n=5 Participants
Age, Customized 91 to 100 years	6 Participants n=5 Participants
Sex: Female, Male Female	286 Participants n=5 Participants
Sex: Female, Male Male	287 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: All enrolled patients with complete data at this time point

BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate Early Treatment Diabetic Retinopathy Study (ETDRS) letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are "approximate ETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). The higher the number of letters read correctly (higher number on the decimal scale), the better the vision (or visual acuity). A positive number change from baseline in the number of letters read means vision has improved and a negative number change from baseline means vision has worsened.

Outcome measures

Outcome measures
Measure	OZURDEX® n=351 Participants OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye Baseline	52.431 Approximate EDTRS Letters Standard Deviation 18.929
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye Change from Baseline at Week 12	7.774 Approximate EDTRS Letters Standard Deviation 14.986

SECONDARY outcome

Timeframe: Baseline, 48 Weeks

Population: All enrolled patients

BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate ETDRS letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are "approximate ETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). An increase of 2 letters or more indicates an improvement in BCVA.

Outcome measures

Outcome measures
Measure	OZURDEX® n=573 Participants OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
Percentage of Patients With an Increase of ≥2 Lines From Baseline BCVA in the Study Eye	46.60 Percentage of Patients

SECONDARY outcome

Timeframe: Baseline, 48 Weeks

Population: All enrolled patients

BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate ETDRS letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are "approximate ETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). An increase of 3 letters or more indicates an improvement in BCVA.

Outcome measures

Outcome measures
Measure	OZURDEX® n=573 Participants OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
Percentage of Patients With an Increase of ≥3 Lines From Baseline BCVA in the Study Eye	36.47 Percentage of Patients

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All enrolled patients with complete data at this time point

Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative mean change from baseline indicates an improvement and a positive mean change from baseline indicates a worsening.

Outcome measures

Outcome measures
Measure	OZURDEX® n=343 Participants OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
Mean Change From Baseline in Central Retinal Thickness Baseline	501.18 micrometers (μm) Standard Deviation 169.30
Mean Change From Baseline in Central Retinal Thickness Change from Baseline at Week 24 (N=138)	-61.75 micrometers (μm) Standard Deviation 192.28

Adverse Events

OZURDEX®

Serious events: 1 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	OZURDEX® n=573 participants at risk OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
Eye disorders Glaucoma	0.17% 1/573 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the time of the first OZURDEX® injection through the final follow-up visit for each patient. All enrolled patients were used to assess AEs and SAEs.

Other adverse events

Other adverse events
Measure	OZURDEX® n=573 participants at risk OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
Eye disorders Intraocular Pressure Increased	5.8% 33/573 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the time of the first OZURDEX® injection through the final follow-up visit for each patient. All enrolled patients were used to assess AEs and SAEs.

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