Trial Outcomes & Findings for A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion (NCT NCT00168298)

Last Updated: 2019-04-23

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

668 participants

Primary outcome timeframe

Day 180

Results posted on

2019-04-23

Participant Flow

Patients were randomly assigned during the double-blind period of the study to treatment with 700 µg dexamethasone, 350 µg dexamethasone, or sham injection on Day 0. Patients who qualified to continue in the open-label period of the study received 700 µg dexamethasone on Day 180.

Participant milestones

Participant milestones
Measure	700 µg Dexamethasone 700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.	350 µg Dexamethasone Followed by 700 µg Dexamethasone 350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.	Sham Injection Followed by 700 µg Dexamethasone Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
Double-Blind Period STARTED	226	218	224
Double-Blind Period COMPLETED	214	206	209
Double-Blind Period NOT COMPLETED	12	12	15
Open-Label Period STARTED	179	173	168
Open-Label Period COMPLETED	172	168	160
Open-Label Period NOT COMPLETED	7	5	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	700 µg Dexamethasone n=226 Participants 700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.	350 µg Dexamethasone Followed by 700 µg Dexamethasone n=218 Participants 350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.	Sham Injection Followed by 700 µg Dexamethasone n=224 Participants Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.	Total n=668 Participants Total of all reporting groups
Age, Customized <45 years	14 participants n=5 Participants	15 participants n=7 Participants	13 participants n=5 Participants	42 participants n=4 Participants
Age, Customized 45-65 years	109 participants n=5 Participants	108 participants n=7 Participants	111 participants n=5 Participants	328 participants n=4 Participants
Age, Customized >65 years	103 participants n=5 Participants	95 participants n=7 Participants	100 participants n=5 Participants	298 participants n=4 Participants
Sex: Female, Male Female	115 Participants n=5 Participants	102 Participants n=7 Participants	101 Participants n=5 Participants	318 Participants n=4 Participants
Sex: Female, Male Male	111 Participants n=5 Participants	116 Participants n=7 Participants	123 Participants n=5 Participants	350 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 180

Population: Intent-to-Treat: all randomized patients

Outcome measures

Outcome measures
Measure	700 µg Dexamethasone n=226 Participants 700 µg Dexamethasone intravitreal implant administered on Day 0.	350 µg Dexamethasone n=218 Participants 350 µg Dexamethasone intravitreal implant administered on Day 0.	Sham Injection n=224 Participants Sham injection on Day 0.
Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye	53 Number of Participants	48 Number of Participants	38 Number of Participants

SECONDARY outcome

Timeframe: Baseline, Day 90, Day 180

Population: Intent-to-Treat: all randomized patients

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 change from baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	700 µg Dexamethasone n=226 Participants 700 µg Dexamethasone intravitreal implant administered on Day 0.	350 µg Dexamethasone n=218 Participants 350 µg Dexamethasone intravitreal implant administered on Day 0.	Sham Injection n=224 Participants Sham injection on Day 0.
Change From Baseline in Retinal Thickness in the Study Eye Baseline	573.6 Microns (µm) Standard Deviation 189.08	566.6 Microns (µm) Standard Deviation 219.63	542.5 Microns (µm) Standard Deviation 185.64
Change From Baseline in Retinal Thickness in the Study Eye Change from Baseline at Day 90	-215.6 Microns (µm) Standard Deviation 207.62	-205.5 Microns (µm) Standard Deviation 216.25	-91.1 Microns (µm) Standard Deviation 191.85
Change From Baseline in Retinal Thickness in the Study Eye Change from Baseline at Day 180	-132.1 Microns (µm) Standard Deviation 207.20	-150.5 Microns (µm) Standard Deviation 220.78	-127.4 Microns (µm) Standard Deviation 197.77

SECONDARY outcome

Timeframe: Baseline, Day 90

Population: Intent-to-Treat: all randomized 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. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and \<15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and \<15 Letters Worsening, and ≥15 Letters Worsening.

Outcome measures

Outcome measures
Measure	700 µg Dexamethasone n=226 Participants 700 µg Dexamethasone intravitreal implant administered on Day 0.	350 µg Dexamethasone n=218 Participants 350 µg Dexamethasone intravitreal implant administered on Day 0.	Sham Injection n=224 Participants Sham injection on Day 0.
Percentage of Patients With a Change From Baseline in BCVA by Category ≥15 Letters Improvement	21.2 Percentage of Patients	25.7 Percentage of Patients	13.8 Percentage of Patients
Percentage of Patients With a Change From Baseline in BCVA by Category ≥5 and <15 Letters Improvement	45.1 Percentage of Patients	39.0 Percentage of Patients	37.1 Percentage of Patients
Percentage of Patients With a Change From Baseline in BCVA by Category No Change (Between -5 to +5 Letters)	25.7 Percentage of Patients	26.6 Percentage of Patients	29.9 Percentage of Patients
Percentage of Patients With a Change From Baseline in BCVA by Category ≥5 and <15 Letters Worsening	4.4 Percentage of Patients	6.4 Percentage of Patients	11.2 Percentage of Patients
Percentage of Patients With a Change From Baseline in BCVA by Category ≥15 Letters Worsening	3.5 Percentage of Patients	2.3 Percentage of Patients	8.0 Percentage of Patients

SECONDARY outcome

Timeframe: Baseline, Day 180

Population: Intent-to-Treat: all randomized 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. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and \<15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and \<15 Letters Worsening, and ≥15 Letters Worsening.

Outcome measures

Outcome measures
Measure	700 µg Dexamethasone n=226 Participants 700 µg Dexamethasone intravitreal implant administered on Day 0.	350 µg Dexamethasone n=218 Participants 350 µg Dexamethasone intravitreal implant administered on Day 0.	Sham Injection n=224 Participants Sham injection on Day 0.
Percentage of Patients With a Change From Baseline in BCVA by Category ≥15 Letters Improvement	23.5 Percentage of Patients	21.6 Percentage of Patients	17.0 Percentage of Patients
Percentage of Patients With a Change From Baseline in BCVA by Category ≥5 and <15 Letters Improvement	35.0 Percentage of Patients	33.9 Percentage of Patients	28.6 Percentage of Patients
Percentage of Patients With a Change From Baseline in BCVA by Category No Change (Between -5 to +5 Letters)	27.0 Percentage of Patients	28.9 Percentage of Patients	28.6 Percentage of Patients
Percentage of Patients With a Change From Baseline in BCVA by Category ≥5 and <15 Letters Worsening	8.0 Percentage of Patients	10.6 Percentage of Patients	13.8 Percentage of Patients
Percentage of Patients With a Change From Baseline in BCVA by Category ≥15 Letters Worsening	6.6 Percentage of Patients	5.0 Percentage of Patients	12.1 Percentage of Patients

Adverse Events

700 µg Dexamethasone

Serious events: 16 serious events

Other events: 168 other events

Deaths: 0 deaths

350 µg Dexamethasone

Serious events: 7 serious events

Other events: 145 other events

Deaths: 0 deaths

Sham Injection

Serious events: 17 serious events

Other events: 94 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	700 µg Dexamethasone n=225 participants at risk 700 µg Dexamethasone intravitreal implant administered on Day 0.	350 µg Dexamethasone n=215 participants at risk 350 µg Dexamethasone intravitreal implant administered on Day 0.	Sham Injection n=221 participants at risk Sham injection on Day 0.
Eye disorders Conjunctival haemorrhage	20.4% 46/225 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6. The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.	17.2% 37/215 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6. The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.	16.7% 37/221 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6. The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
Eye disorders Conjunctival hyperaemia	8.0% 18/225 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6. The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.	7.4% 16/215 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6. The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.	5.9% 13/221 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6. The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
Eye disorders Eye pain	8.0% 18/225 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6. The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.	4.7% 10/215 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6. The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.	4.5% 10/221 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6. The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
Eye disorders Maculopathy	3.6% 8/225 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6. The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.	7.0% 15/215 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6. The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.	2.7% 6/221 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6. The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
Eye disorders Retinal exudates	2.7% 6/225 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6. The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.	0.93% 2/215 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6. The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.	5.4% 12/221 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6. The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
Investigations Intraocular pressure increased	26.7% 60/225 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6. The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.	26.0% 56/215 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6. The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.	2.3% 5/221 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6. The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
Vascular disorders Hypertension	5.3% 12/225 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6. The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.	4.2% 9/215 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6. The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.	5.0% 11/221 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6. The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.

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