Trial Outcomes & Findings for Study Assessing AR-1105 in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO) (NCT NCT03739593)

Last Updated: 2022-02-28

Results Overview

Treatment-emergent adverse events summarized at the subject level by system organ class and preferred term are available in the Adverse Events module. Data reported in the table below corresponds to the total number of participants with ocular and non-ocular treatment-emergent adverse events (TEAEs).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

49 participants

Primary outcome timeframe

Up to 6 months treatment duration

Results posted on

2022-02-28

Participant Flow

Participant milestones

Participant milestones
Measure	Initial Phase: AR-1105-CF1 Single dose of AR- 1105-clinical formulation 1 (CF1) dexamethasone 340 mcg administered as an intravitreal implant into a single eye	Randomization Phase: AR-1105-CF1 Single dose of AR- 1105-clinical formulation 1 (CF1) dexamethasone 340 mcg administered as an intravitreal implant into a single eye	Randomization Phase: AR-1105-CF2 Single dose of AR- 1105-clinical formulation 2 (CF2) dexamethasone 340 mcg administered as an intravitreal implant into a single eye
Overall Study STARTED	5	22	22
Overall Study COMPLETED	2	16	14
Overall Study NOT COMPLETED	3	6	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study Assessing AR-1105 in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AR-1105-CF1 Initial Phase n=5 Participants Single dose of AR-1105-CF1 (dexamethasone 340 mcg) administered as an intravitreal implant into a single eye	AR-1105-CF1 Randomization Phase n=22 Participants Single dose of AR-1105-CF1 (dexamethasone 340 mcg) administered as an intravitreal implant into a single eye	AR-1105-CF2 Randomization Phase n=22 Participants Single dose of AR-1105-CF2 (dexamethasone, 340 mcg) administered as an intravitreal implant into a single eye	Total n=49 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	10 Participants n=7 Participants	6 Participants n=5 Participants	18 Participants n=4 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	12 Participants n=7 Participants	16 Participants n=5 Participants	31 Participants n=4 Participants
Age, Continuous	67 Years n=5 Participants	66 Years n=7 Participants	72 Years n=5 Participants	68 Years n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants	22 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	13 Participants n=7 Participants	9 Participants n=5 Participants	27 Participants n=4 Participants
Race/Ethnicity, Customized Race : American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Race : Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Race : Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Race : Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Race : White	5 Participants n=5 Participants	19 Participants n=7 Participants	19 Participants n=5 Participants	43 Participants n=4 Participants
Race/Ethnicity, Customized Race : Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Race : Multiple Race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	5 participants n=5 Participants	22 participants n=7 Participants	22 participants n=5 Participants	49 participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 6 months treatment duration

Population: All safety evaluations were conducted on subjects in the safety population. The safety population included all subjects who received study medication. This population was used to summarize safety variables. Subjects were analyzed as-treated

Outcome measures

Outcome measures
Measure	Initial Phase: AR-1105-CF1 n=5 Participants Single dose of AR-1105-clinical formulation 1 (CF1) dexamethasone 340 mcg administered as an intravitreal implant into a single eye	Randomization Phase: AR-1105-CF1 n=22 Participants Single dose of AR-1105-clinical formulation 1 (CF1) dexamethasone 340 mcg administered as an intravitreal implant into a single eye	Randomization Phase: AR-1105-CF2 n=22 Participants Single dose of AR-1105-clinical formulation 2 (CF2) dexamethasone 340 mcg administered as an intravitreal implant into a single eye
Safety Tolerability: Number of Ocular and Non-ocular TEAEs	5 participants	22 participants	22 participants

Adverse Events

Initial Phase: AR-1105-CF1

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Randomization Phase: AR-1105-CF1

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Randomization Phase: AR-1105-CF2

Serious events: 4 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Initial Phase: AR-1105-CF1 n=5 participants at risk Single dose of AR- 1105-clinical formulation 1 (CF1) dexamethasone 340 mcg administered as an intravitreal implant into a single eye	Randomization Phase: AR-1105-CF1 n=22 participants at risk Single dose of AR- 1105-clinical formulation 1 (CF1) dexamethasone 340 mcg administered as an intravitreal implant into a single eye	Randomization Phase: AR-1105-CF2 n=22 participants at risk Single dose of AR- 1105-clinical formulation 1 (CF2) dexamethasone 340 mcg administered as an intravitreal implant into a single eye
Infections and infestations Pneumonia	0.00% 0/5 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.	0.00% 0/22 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.	4.5% 1/22 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.
Eye disorders Visual Acuity Reduced	20.0% 1/5 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.	4.5% 1/22 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.	9.1% 2/22 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.
Eye disorders Iris Neovascularization	20.0% 1/5 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.	0.00% 0/22 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.	0.00% 0/22 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.
Cardiac disorders Angina Pectoris	0.00% 0/5 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.	0.00% 0/22 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.	4.5% 1/22 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.
Eye disorders Cataract	0.00% 0/5 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.	0.00% 0/22 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.	4.5% 1/22 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.
Eye disorders Visual Impairment	0.00% 0/5 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.	4.5% 1/22 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.	0.00% 0/22 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.

Other adverse events

Other adverse events
Measure	Initial Phase: AR-1105-CF1 n=5 participants at risk Single dose of AR- 1105-clinical formulation 1 (CF1) dexamethasone 340 mcg administered as an intravitreal implant into a single eye	Randomization Phase: AR-1105-CF1 n=22 participants at risk Single dose of AR- 1105-clinical formulation 1 (CF1) dexamethasone 340 mcg administered as an intravitreal implant into a single eye	Randomization Phase: AR-1105-CF2 n=22 participants at risk Single dose of AR- 1105-clinical formulation 1 (CF2) dexamethasone 340 mcg administered as an intravitreal implant into a single eye
Eye disorders Visual Acuity Reduced	20.0% 1/5 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.	9.1% 2/22 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.	13.6% 3/22 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.
Eye disorders Macular Edema	40.0% 2/5 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.	18.2% 4/22 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.	9.1% 2/22 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.
Eye disorders Conjunctival Haemorrhage	40.0% 2/5 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.	9.1% 2/22 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.	4.5% 1/22 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.
Eye disorders Ocular Hypertension	0.00% 0/5 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.	0.00% 0/22 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.	13.6% 3/22 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.
Eye disorders Vitreous Haemorrhage	0.00% 0/5 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.	0.00% 0/22 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.	13.6% 3/22 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.
Eye disorders Vitreous Floaters	0.00% 0/5 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.	0.00% 0/22 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.	9.1% 2/22 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.
Investigations Intraocular Pressure Increased	20.0% 1/5 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.	4.5% 1/22 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.	13.6% 3/22 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.
Infections and infestations Nasopharyngitis	0.00% 0/5 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.	9.1% 2/22 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.	0.00% 0/22 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.
Metabolism and nutrition disorders Type 2 Diabetes Mellitus	20.0% 1/5 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.	0.00% 0/22 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.	0.00% 0/22 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.
Eye disorders Vision Blurred	20.0% 1/5 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.	0.00% 0/22 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.	0.00% 0/22 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.
Product Issues Device Malfunction	20.0% 1/5 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.	0.00% 0/22 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.	0.00% 0/22 • Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.

Additional Information

Kevin Kerr, Director of Clinical Development

Aerie Pharmaceuticals, Inc

Phone: (949) 526-8701

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place