Trial Outcomes & Findings for Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO) (NCT NCT01660802)

Results Overview

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. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

262 participants

Primary outcome timeframe

Baseline, 6 Months

Results posted on

2019-04-17

Participant Flow

Participant milestones

Participant milestones
Measure	700 μg Dexamethasone 700 μg Dexamethasone intravitreal injection in the study eye on Day 1.	Sham Sham administered in the study eye on Day 1.
Overall Study STARTED	130	132
Overall Study COMPLETED	126	121
Overall Study NOT COMPLETED	4	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	700 μg Dexamethasone n=130 Participants 700 μg Dexamethasone intravitreal injection in the study eye on Day 1.	Sham n=132 Participants Sham administered in the study eye on Day 1.	Total n=262 Participants Total of all reporting groups
Age, Customized <45 years	18 Participants n=5 Participants	25 Participants n=7 Participants	43 Participants n=5 Participants
Age, Customized 45 to 65 years	94 Participants n=5 Participants	86 Participants n=7 Participants	180 Participants n=5 Participants
Age, Customized > 65 years	18 Participants n=5 Participants	21 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	76 Participants n=7 Participants	136 Participants n=5 Participants
Sex: Female, Male Male	70 Participants n=5 Participants	56 Participants n=7 Participants	126 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 6 Months

Population: Modified Intent-to-Treat: all randomized and treated patients

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. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.

Outcome measures

Outcome measures
Measure	700 μg Dexamethasone n=129 Participants 700 μg Dexamethasone intravitreal injection in the study eye on Day 1.	Sham n=130 Participants Sham administered in the study eye on Day 1.
Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye	60 Patients	31 Patients

SECONDARY outcome

Timeframe: Baseline, 6 Months

Population: Modified Intent-to-Treat: all randomized and treated patients

BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.

Outcome measures

Outcome measures
Measure	700 μg Dexamethasone n=129 Participants 700 μg Dexamethasone intravitreal injection in the study eye on Day 1.	Sham n=130 Participants Sham administered in the study eye on Day 1.
Average Change From Baseline in BCVA in the Study Eye Baseline	52.6 Letters Read Correctly Standard Deviation 10.79	53.1 Letters Read Correctly Standard Deviation 10.47
Average Change From Baseline in BCVA in the Study Eye Average Change from Baseline Over 6 Months	6.6 Letters Read Correctly Standard Deviation 8.98	2.5 Letters Read Correctly Standard Deviation 9.98

SECONDARY outcome

Timeframe: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6

Population: Modified Intent-to-Treat: all randomized and treated patients

BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. 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. A decrease in the number of letters read correctly (negative number) means that vision has worsened.

Outcome measures

Outcome measures
Measure	700 μg Dexamethasone n=129 Participants 700 μg Dexamethasone intravitreal injection in the study eye on Day 1.	Sham n=130 Participants Sham administered in the study eye on Day 1.
Change From Baseline in BCVA in the Study Eye Change from Baseline at Month 1	9.1 Letters Read Correctly Standard Deviation 8.45	2.0 Letters Read Correctly Standard Deviation 9.28
Change From Baseline in BCVA in the Study Eye Change from Baseline at Month 2	10.6 Letters Read Correctly Standard Deviation 10.36	1.7 Letters Read Correctly Standard Deviation 12.29
Change From Baseline in BCVA in the Study Eye Change from Baseline at Month 3	7.7 Letters Read Correctly Standard Deviation 12.66	1.8 Letters Read Correctly Standard Deviation 12.98
Change From Baseline in BCVA in the Study Eye Baseline	52.6 Letters Read Correctly Standard Deviation 10.79	53.1 Letters Read Correctly Standard Deviation 10.47
Change From Baseline in BCVA in the Study Eye Change from Baseline at Month 4	5.2 Letters Read Correctly Standard Deviation 12.79	3.3 Letters Read Correctly Standard Deviation 12.32
Change From Baseline in BCVA in the Study Eye Change from Baseline at Month 5	4.4 Letters Read Correctly Standard Deviation 13.28	3.3 Letters Read Correctly Standard Deviation 13.04
Change From Baseline in BCVA in the Study Eye Change from Baseline at Month 6	3.2 Letters Read Correctly Standard Deviation 15.34	4.0 Letters Read Correctly Standard Deviation 13.73

SECONDARY outcome

Timeframe: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6

Population: Modified Intent-to-Treat: all randomized and treated patients

BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. 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 indicates improvement and a decrease in the number of letters read correctly indicates a worsening.

Outcome measures

Outcome measures
Measure	700 μg Dexamethasone n=129 Participants 700 μg Dexamethasone intravitreal injection in the study eye on Day 1.	Sham n=130 Participants Sham administered in the study eye on Day 1.
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye Month 1	28.7 Percentage of Patients	5.4 Percentage of Patients
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye Month 2	34.9 Percentage of Patients	11.5 Percentage of Patients
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye Month 3	33.3 Percentage of Patients	13.1 Percentage of Patients
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye Month 4	23.3 Percentage of Patients	14.6 Percentage of Patients
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye Month 5	22.5 Percentage of Patients	22.3 Percentage of Patients
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye Month 6	23.3 Percentage of Patients	20.8 Percentage of Patients

Adverse Events

700 μg Dexamethasone

Serious events: 1 serious events

Other events: 69 other events

Deaths: 0 deaths

Sham

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	700 μg Dexamethasone n=129 participants at risk 700 μg Dexamethasone intravitreal injection in the study eye on Day 1.	Sham n=130 participants at risk Sham administered in the study eye on Day 1.
Cardiac disorders Atrioventricular Block	0.78% 1/129 The Safety Population included all treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs). Treatment emergent adverse events (TEAE) are reported and include all AEs and SAEs that began or worsened after study treatment.	0.00% 0/130 The Safety Population included all treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs). Treatment emergent adverse events (TEAE) are reported and include all AEs and SAEs that began or worsened after study treatment.
Hepatobiliary disorders Cholecystitis Chronic	0.00% 0/129 The Safety Population included all treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs). Treatment emergent adverse events (TEAE) are reported and include all AEs and SAEs that began or worsened after study treatment.	0.77% 1/130 The Safety Population included all treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs). Treatment emergent adverse events (TEAE) are reported and include all AEs and SAEs that began or worsened after study treatment.
Eye disorders Vitreous Haemorrhage	0.00% 0/129 The Safety Population included all treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs). Treatment emergent adverse events (TEAE) are reported and include all AEs and SAEs that began or worsened after study treatment.	0.77% 1/130 The Safety Population included all treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs). Treatment emergent adverse events (TEAE) are reported and include all AEs and SAEs that began or worsened after study treatment.

Other adverse events

Other adverse events
Measure	700 μg Dexamethasone n=129 participants at risk 700 μg Dexamethasone intravitreal injection in the study eye on Day 1.	Sham n=130 participants at risk Sham administered in the study eye on Day 1.
Eye disorders Conjunctival Haemorrhage	18.6% 24/129 The Safety Population included all treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs). Treatment emergent adverse events (TEAE) are reported and include all AEs and SAEs that began or worsened after study treatment.	3.8% 5/130 The Safety Population included all treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs). Treatment emergent adverse events (TEAE) are reported and include all AEs and SAEs that began or worsened after study treatment.
Eye disorders Conjunctival Hyperaemia	13.2% 17/129 The Safety Population included all treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs). Treatment emergent adverse events (TEAE) are reported and include all AEs and SAEs that began or worsened after study treatment.	4.6% 6/130 The Safety Population included all treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs). Treatment emergent adverse events (TEAE) are reported and include all AEs and SAEs that began or worsened after study treatment.
Investigations Intraocular Pressure Increased	29.5% 38/129 The Safety Population included all treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs). Treatment emergent adverse events (TEAE) are reported and include all AEs and SAEs that began or worsened after study treatment.	3.1% 4/130 The Safety Population included all treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs). Treatment emergent adverse events (TEAE) are reported and include all AEs and SAEs that began or worsened after study treatment.

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 at least 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