Trial Outcomes & Findings for Efficacy and Safety Study of ESBA1008 Versus EYLEA® (NCT NCT01796964)

Last Updated: 2016-02-09

Results Overview

This outcome measure was used to compare the ESBA1008 and EYLEA groups in regards to fluctuations in treatment effect during the maintenance phase with 8-week treatment cycles (ie, to evaluate treatment effect stability during the maintenance phase). BCVA (with spectacles or other visual corrective devices) using Early Treatment Diabetic Retinopathy Study (ETDRS) testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

173 participants

Primary outcome timeframe

Baseline (Day 0), Week 12

Results posted on

2016-02-09

Participant Flow

Subjects were recruited from 41 investigational centers located in the US.

Of the 173 enrolled, 83 subjects were exited as screen failures prior to randomization. One randomized subject did not receive treatment. Another subject randomized to ESBA 1008 received EYLEA treatment. This reporting group includes all randomized and treated subjects, as treated (ESBA1008: 44 subjects and EYLEA: 45 subjects).

Participant milestones

Participant milestones
Measure	ESBA1008 ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol	EYLEA Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
Overall Study STARTED	44	45
Overall Study COMPLETED	41	42
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	ESBA1008 ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol	EYLEA Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
Overall Study Adverse Event	1	1
Overall Study Death	1	0
Overall Study Protocol Violation	0	1
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Efficacy and Safety Study of ESBA1008 Versus EYLEA®

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ESBA1008 n=44 Participants ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol	EYLEA n=45 Participants Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol	Total n=89 Participants Total of all reporting groups
Age, Continuous	78.8 years STANDARD_DEVIATION 9.7 • n=5 Participants	77.3 years STANDARD_DEVIATION 9.1 • n=7 Participants	78.0 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	25 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	20 Participants n=7 Participants	36 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 0), Week 12

Population: This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.

Outcome measures

Outcome measures
Measure	ESBA1008 n=44 Participants ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol	EYLEA n=45 Participants Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
Best-Corrected Visual Acuity (BCVA) Change From Baseline (No. of Letters) to Week 12 Change from baseline	5.8 letters Standard Deviation 12.7	6.9 letters Standard Deviation 9.3
Best-Corrected Visual Acuity (BCVA) Change From Baseline (No. of Letters) to Week 12 Baseline (Day 0)	54.1 letters Standard Deviation 13.9	55.6 letters Standard Deviation 12.3

SECONDARY outcome

Timeframe: Baseline (Day 0), Week 16

BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.

Outcome measures

Outcome measures
Measure	ESBA1008 n=44 Participants ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol	EYLEA n=45 Participants Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
BCVA Change From Baseline (No. of Letters) to Week 16 Baseline (Day 0)	54.1 letters Standard Deviation 13.9	55.6 letters Standard Deviation 12.3
BCVA Change From Baseline (No. of Letters) to Week 16 Change from baseline	6.0 letters Standard Deviation 13.3	6.6 letters Standard Deviation 9.2

SECONDARY outcome

Timeframe: Baseline (Day 0), Week 4, Week 8, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56

Outcome measures

Outcome measures
Measure	ESBA1008 n=44 Participants ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol	EYLEA n=45 Participants Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
BCVA Change From Baseline (No. of Letters) by Visit Change from baseline at Week 4	4.8 letters Standard Deviation 9.1	4.3 letters Standard Deviation 7.4
BCVA Change From Baseline (No. of Letters) by Visit Change from baseline at Week 8	6.0 letters Standard Deviation 11.6	6.5 letters Standard Deviation 8.5
BCVA Change From Baseline (No. of Letters) by Visit Change from baseline at Week 20	7.5 letters Standard Deviation 14.5	7.3 letters Standard Deviation 9.4
BCVA Change From Baseline (No. of Letters) by Visit Change from baseline at Week 24	7.1 letters Standard Deviation 13.0	8.2 letters Standard Deviation 11.2
BCVA Change From Baseline (No. of Letters) by Visit Change from baseline at Week 28	8.3 letters Standard Deviation 12.2	6.6 letters Standard Deviation 12.4
BCVA Change From Baseline (No. of Letters) by Visit Change from baseline at Week 32	6.7 letters Standard Deviation 13.7	6.5 letters Standard Deviation 12.7
BCVA Change From Baseline (No. of Letters) by Visit Change from baseline at Week 36	6.2 letters Standard Deviation 16.2	6.4 letters Standard Deviation 13.1
BCVA Change From Baseline (No. of Letters) by Visit Change from baseline at Week 40	6.3 letters Standard Deviation 14.9	5.7 letters Standard Deviation 13.6
BCVA Change From Baseline (No. of Letters) by Visit Change from baseline at Week 44	7.0 letters Standard Deviation 15.6	6.5 letters Standard Deviation 12.0
BCVA Change From Baseline (No. of Letters) by Visit Baseline (Day 0)	54.1 letters Standard Deviation 13.9	55.6 letters Standard Deviation 12.3
BCVA Change From Baseline (No. of Letters) by Visit Change from baseline at Week 48	6.2 letters Standard Deviation 16.5	6.8 letters Standard Deviation 13.4
BCVA Change From Baseline (No. of Letters) by Visit Change from baseline at Week 52	6.0 letters Standard Deviation 16.4	7.2 letters Standard Deviation 13.2
BCVA Change From Baseline (No. of Letters) by Visit Change from baseline at Week 56	4.9 letters Standard Deviation 17.9	7.3 letters Standard Deviation 13.4

SECONDARY outcome

Timeframe: Baseline (Day 0), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56

The purpose of this outcome measure was to assess the integrated effect of the treatment for different study periods and to provide more robust estimate of the absolute treatment effects. BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. These changes were computed as the average of the changes from baseline to each monthly study visit corresponding to each period. One eye (study eye) contributed to the analysis.

Outcome measures

Outcome measures
Measure	ESBA1008 n=44 Participants ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol	EYLEA n=45 Participants Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
Average BCVA Change From Baseline (No. of Letters) Over the Periods of Week 4 to Week 16, Week 4 to Week 24, Week 4 to Week 40, and Week 4 to Week 56 Avg Change from baseline over period of Weeks 4-16	5.7 letters Standard Deviation 11.0	6.1 letters Standard Deviation 8.0
Average BCVA Change From Baseline (No. of Letters) Over the Periods of Week 4 to Week 16, Week 4 to Week 24, Week 4 to Week 40, and Week 4 to Week 56 Avg Change from baseline over period of Weeks 4-40	6.5 letters Standard Deviation 12.3	6.5 letters Standard Deviation 9.2
Average BCVA Change From Baseline (No. of Letters) Over the Periods of Week 4 to Week 16, Week 4 to Week 24, Week 4 to Week 40, and Week 4 to Week 56 Avg Change from baseline over period of Weeks 4-56	6.4 letters Standard Deviation 13.3	6.6 letters Standard Deviation 10.0
Average BCVA Change From Baseline (No. of Letters) Over the Periods of Week 4 to Week 16, Week 4 to Week 24, Week 4 to Week 40, and Week 4 to Week 56 Baseline (Day 0)	54.1 letters Standard Deviation 13.9	55.6 letters Standard Deviation 12.3
Average BCVA Change From Baseline (No. of Letters) Over the Periods of Week 4 to Week 16, Week 4 to Week 24, Week 4 to Week 40, and Week 4 to Week 56 Avg Change from baseline over period of Weeks 4-24	6.2 letters Standard Deviation 11.7	6.6 letters Standard Deviation 8.4

SECONDARY outcome

Timeframe: Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56

The purpose of this outcome measure was to assess the average maintenance level of BCVA following the 3 loading treatments (ie, after Week 12). BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. These changes were computed as the average of the changes from Week 12 to each monthly study visit corresponding to each period. One eye (study eye) contributed to the analysis.

Outcome measures

Outcome measures
Measure	ESBA1008 n=44 Participants ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol	EYLEA n=45 Participants Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
Average BCVA Change From Week 12 (No. of Letters) Over the Periods of Week 16 to Week 24, Week 16 Week 40, and Week 16 to Week 56 Avg Change from Week 12 over period Weeks 16-24	1.1 letters Standard Deviation 5.4	0.5 letters Standard Deviation 4.7
Average BCVA Change From Week 12 (No. of Letters) Over the Periods of Week 16 to Week 24, Week 16 Week 40, and Week 16 to Week 56 Avg Change from Week 12 over period Weeks 16-56	0.8 letters Standard Deviation 7.0	-0.0 letters Standard Deviation 8.1
Average BCVA Change From Week 12 (No. of Letters) Over the Periods of Week 16 to Week 24, Week 16 Week 40, and Week 16 to Week 56 Week 12	59.8 letters Standard Deviation 18.5	62.4 letters Standard Deviation 16.1
Average BCVA Change From Week 12 (No. of Letters) Over the Periods of Week 16 to Week 24, Week 16 Week 40, and Week 16 to Week 56 Avg Change from Week 12 over period Weeks 16-40	1.1 letters Standard Deviation 6.3	-0.1 letters Standard Deviation 7.3

SECONDARY outcome

Timeframe: Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56

The purpose of this outcome measure was to assess the stability of BCVA during the second month of 8-week/12-week treatment cycles and specifically to identify potential under treatment. BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.

Outcome measures

Outcome measures
Measure	ESBA1008 n=44 Participants ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol	EYLEA n=45 Participants Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
One-Month BCVA Changes (No. of Letters) Following No Treatment for 1-Month Change from Week 12 to Week 16	0.3 letters Standard Deviation 5.7	-0.2 letters Standard Deviation 5.1
One-Month BCVA Changes (No. of Letters) Following No Treatment for 1-Month Change from Week 20 to Week 24	-0.4 letters Standard Deviation 4.8	0.9 letters Standard Deviation 5.5
One-Month BCVA Changes (No. of Letters) Following No Treatment for 1-Month Change from Week 28 to Week 32	-1.7 letters Standard Deviation 4.6	-0.1 letters Standard Deviation 3.6
One-Month BCVA Changes (No. of Letters) Following No Treatment for 1-Month Change from Week 48 to Week 52	-0.1 letters Standard Deviation 4.3	NA letters Standard Deviation NA Subjects in the EYLEA group received IVT injections at Day 0, Weeks 4, 8, 16, 24, 32, 40, and 48.
One-Month BCVA Changes (No. of Letters) Following No Treatment for 1-Month Change from Week 52 to Week 56	NA letters Standard Deviation NA Subjects in the ESBA1008 group received active IVT injections at Day 0 and at Weeks 4, 8, 16, 24, 32, and 44.	0.0 letters Standard Deviation 4.2
One-Month BCVA Changes (No. of Letters) Following No Treatment for 1-Month Change from Week 36 to Week 40	0.1 letters Standard Deviation 7.3	-0.7 letters Standard Deviation 4.0
One-Month BCVA Changes (No. of Letters) Following No Treatment for 1-Month Change from Week 44 to Week 48	NA letters Standard Deviation NA Subjects in the ESBA1008 group received active IVT injections at Day 0 and at Weeks 4, 8, 16, 24, 32, and 44.	0.2 letters Standard Deviation 4.2

SECONDARY outcome

Timeframe: Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52

The purpose of this outcome measure was to assess the potential treatment needs present at these treatment visits. BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.

Outcome measures

Outcome measures
Measure	ESBA1008 n=44 Participants ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol	EYLEA n=45 Participants Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
One-Month BCVA Changes (No. of Letters) Following Treatment by Visit Change from Week 16 to Week 20	1.5 letters Standard Deviation 5.7	0.6 letters Standard Deviation 5.1
One-Month BCVA Changes (No. of Letters) Following Treatment by Visit Change from Week 24 to Week 28	1.2 letters Standard Deviation 5.6	-1.6 letters Standard Deviation 7.7
One-Month BCVA Changes (No. of Letters) Following Treatment by Visit Change from Week 40 to Week 44	NA letters Standard Deviation NA Subjects in the ESBA1008 group received active IVT injections at Day 0 and at Weeks 4, 8, 16, 24, 32, and 44.	0.8 letters Standard Deviation 5.2
One-Month BCVA Changes (No. of Letters) Following Treatment by Visit Change from Week 44 to Week 48	-0.8 letters Standard Deviation 4.2	NA letters Standard Deviation NA Subjects in the EYLEA group received IVT injections at Day 0, Weeks 4, 8, 16, 24, 32, 40, and 48.
One-Month BCVA Changes (No. of Letters) Following Treatment by Visit Change from Week 48 to Week 52	NA letters Standard Deviation NA Subjects in the ESBA1008 group received active IVT injections at Day 0 and at Weeks 4, 8, 16, 24, 32, and 44.	0.5 letters Standard Deviation 3.6
One-Month BCVA Changes (No. of Letters) Following Treatment by Visit Change from Week 32 at Week 36	-0.5 letters Standard Deviation 7.9	-0.2 letters Standard Deviation 5.1

SECONDARY outcome

Timeframe: Week 36, Week 44, Week 48, Week 56

Outcome measures

Outcome measures
Measure	ESBA1008 n=44 Participants ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol	EYLEA Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
Two-Months BCVA Changes (No. of Letters) Following No Treatment for 1 Month in ESBA Treatment Group Change from Week 36 to Week 44	0.8 letters Standard Deviation 7.1	—
Two-Months BCVA Changes (No. of Letters) Following No Treatment for 1 Month in ESBA Treatment Group Change from Week 48 to Week 56	-1.3 letters Standard Deviation 5.0	—

SECONDARY outcome

Timeframe: Baseline (Day 0), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56

CSFT (average thickness in the central subfield centered at the fovea) as measured using Spectral-Domain Optical Coherence Tomography (SD-OCT). Reduction in CSFT measurement from baseline indicates improvement. One eye (study eye) contributed to the analysis.

Outcome measures

Outcome measures
Measure	ESBA1008 n=44 Participants ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol	EYLEA n=45 Participants Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
Central Subfield Thickness (CSFT) Change From Baseline by Visit Change from baseline at Week 16	-188.4 microns Standard Deviation 121.0	-163.2 microns Standard Deviation 116.4
Central Subfield Thickness (CSFT) Change From Baseline by Visit Change from baseline at Week 20	-207.0 microns Standard Deviation 123.2	-184.8 microns Standard Deviation 118.5
Central Subfield Thickness (CSFT) Change From Baseline by Visit Change from baseline at Week 24	-194.0 microns Standard Deviation 127.9	-164.0 microns Standard Deviation 121.8
Central Subfield Thickness (CSFT) Change From Baseline by Visit Change from baseline at Week 28	-210.0 microns Standard Deviation 125.0	-185.9 microns Standard Deviation 117.9
Central Subfield Thickness (CSFT) Change From Baseline by Visit Baseline (Day 0)	490.1 microns Standard Deviation 149.2	495.7 microns Standard Deviation 144.6
Central Subfield Thickness (CSFT) Change From Baseline by Visit Change from baseline at Week 4	-184.7 microns Standard Deviation 118.9	-153.0 microns Standard Deviation 95.1
Central Subfield Thickness (CSFT) Change From Baseline by Visit Change from baseline at Week 8	-198.5 microns Standard Deviation 117.6	-176.1 microns Standard Deviation 106.5
Central Subfield Thickness (CSFT) Change From Baseline by Visit Change from baseline at Week 12	-199.5 microns Standard Deviation 126.7	-186.2 microns Standard Deviation 113.6
Central Subfield Thickness (CSFT) Change From Baseline by Visit Change from baseline at Week 32	-205.8 microns Standard Deviation 124.3	-166.4 microns Standard Deviation 123.2
Central Subfield Thickness (CSFT) Change From Baseline by Visit Change from baseline at Week 36	-213.0 microns Standard Deviation 132.4	-185.3 microns Standard Deviation 117.7
Central Subfield Thickness (CSFT) Change From Baseline by Visit Change from baseline at Week 40	-200.6 microns Standard Deviation 143.6	-175.2 microns Standard Deviation 124.1
Central Subfield Thickness (CSFT) Change From Baseline by Visit Change from baseline at Week 44	-196.1 microns Standard Deviation 120.2	-184.6 microns Standard Deviation 121.7
Central Subfield Thickness (CSFT) Change From Baseline by Visit Change from baseline at Week 48	-213.0 microns Standard Deviation 129.7	-175.7 microns Standard Deviation 124.3
Central Subfield Thickness (CSFT) Change From Baseline by Visit Change from baseline at Week 52	-210.5 microns Standard Deviation 130.6	-198.8 microns Standard Deviation 123.4
Central Subfield Thickness (CSFT) Change From Baseline by Visit Change from baseline at Week 56	-196.8 microns Standard Deviation 135.4	-180.4 microns Standard Deviation 121.6

Adverse Events

Pre-treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ESBA 1008

Serious events: 11 serious events

Other events: 22 other events

Deaths: 0 deaths

EYLEA

Serious events: 9 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Pre-treatment n=173 participants at risk All subjects who consented to participate in the study	ESBA 1008 n=44 participants at risk All subjects who were randomized and received at least 1 IVT injection of ESBA1008 solution	EYLEA n=45 participants at risk All subjects who were randomized and received at least 1 IVT injection of Aflibercept
Eye disorders Age-related macular degeneration	0.00% 0/173 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.	11.4% 5/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.	4.4% 2/45 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.
Eye disorders Cataract	0.00% 0/173 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.	2.3% 1/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.	6.7% 3/45 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.
Eye disorders Conjunctival haemorrhage	0.00% 0/173 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.	11.4% 5/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.	15.6% 7/45 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.
Eye disorders Foreign body sensation in eyes	0.00% 0/173 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.	0.00% 0/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.	6.7% 3/45 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.
Eye disorders Macular fibrosis	0.00% 0/173 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.	6.8% 3/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.	2.2% 1/45 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.
Eye disorders Punctate keratitis	0.00% 0/173 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.	4.5% 2/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.	6.7% 3/45 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.
Eye disorders Retinal haemorrhage	0.00% 0/173 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.	4.5% 2/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.	6.7% 3/45 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.
Eye disorders Vision blurred	0.00% 0/173 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.	4.5% 2/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.	6.7% 3/45 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.
Eye disorders Visual acuity reduced	0.00% 0/173 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.	11.4% 5/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.	8.9% 4/45 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.
Eye disorders Vitreous detachment	0.00% 0/173 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.	6.8% 3/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.	8.9% 4/45 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.
Eye disorders Vitreous floaters	0.00% 0/173 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.	11.4% 5/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.	8.9% 4/45 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.
Gastrointestinal disorders Nausea	0.00% 0/173 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.	6.8% 3/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.	2.2% 1/45 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.
Infections and infestations Upper respiratory tract infection	0.00% 0/173 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.	11.4% 5/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.	6.7% 3/45 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.
Infections and infestations Urinary tract infection	0.00% 0/173 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.	4.5% 2/44 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.	8.9% 4/45 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.

Additional Information

Clinical Project Group Lead, GCRA, Pharma

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER