Trial Outcomes & Findings for A Study of the Response to AG-86893 in Patients With Pterygium Hyperemia (NCT NCT03533244)

Last Updated: 2020-11-06

Results Overview

Assessed by digital ocular photography; each quadrant of the eye (superior, inferior, nasal, temporal) will be scored using a 5-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe) and graded by a reading center. The overall conjunctival score is the average of the four quadrants. Assessments are made by subtracting the score at Baseline from the score on Day 28. An increase in value indicates worsening of hyperemia, while a decrease indicates improvement.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

64 participants

Primary outcome timeframe

Baseline and Day 28

Results posted on

2020-11-06

Participant Flow

Participant milestones

Participant milestones
Measure	Vehicle Eye Drops One drop, three times daily to the study eye for 28 days Vehicle Eye Drops: One drop, three times daily to the study eye for 28 days	0.1% AG-86893 Eye Drops One drop, three times daily to the study eye for 28 days 0.1% AG-86893 Eye Drops: One drop, three times daily to the study eye for 28 days	0.3% AG-86893 Eye Drops One drop, three times daily to the study eye for 28 days 0.3% AG-86893 Eye Drops: One drop, three times daily to the study eye for 28 days
Overall Study STARTED	20	22	22
Overall Study COMPLETED	18	21	22
Overall Study NOT COMPLETED	2	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of the Response to AG-86893 in Patients With Pterygium Hyperemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vehicle Eye Drops n=20 Participants One drop, three times daily to the study eye for 28 days Vehicle Eye Drops: One drop, three times daily to the study eye for 28 days	0.1% AG-86893 Eye Drops n=22 Participants One drop, three times daily to the study eye for 28 days 0.1% AG-86893 Eye Drops: One drop, three times daily to the study eye for 28 days	0.3% AG-86893 Eye Drops n=22 Participants One drop, three times daily to the study eye for 28 days 0.3% AG-86893 Eye Drops: One drop, three times daily to the study eye for 28 days	Total n=64 Participants Total of all reporting groups
Age, Continuous	49.8 years STANDARD_DEVIATION 12.4 • n=5 Participants	54.7 years STANDARD_DEVIATION 11.9 • n=7 Participants	49.0 years STANDARD_DEVIATION 10.7 • n=5 Participants	51.2 years STANDARD_DEVIATION 11.8 • n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants	26 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	17 Participants n=7 Participants	11 Participants n=5 Participants	38 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) 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 (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	21 Participants n=7 Participants	19 Participants n=5 Participants	58 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Region of Enrollment Australia	20 Participants n=5 Participants	22 Participants n=7 Participants	22 Participants n=5 Participants	64 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and Day 28

Population: modified intent-to-treat (mITT)

Outcome measures

Outcome measures
Measure	Vehicle Eye Drops n=18 Participants One drop, three times daily to the study eye for 28 days Vehicle Eye Drops: One drop, three times daily to the study eye for 28 days	0.1% AG-86893 Eye Drops n=22 Participants One drop, three times daily to the study eye for 28 days 0.1% AG-86893 Eye Drops: One drop, three times daily to the study eye for 28 days	0.3% AG-86893 Eye Drops n=22 Participants One drop, three times daily to the study eye for 28 days 0.3% AG-86893 Eye Drops: One drop, three times daily to the study eye for 28 days
Change From Baseline in Overall Conjunctival Hyperemia Score	-0.056 score on a scale Standard Error 0.120	-0.330 score on a scale Standard Error 0.109	-0.352 score on a scale Standard Error 0.109

SECONDARY outcome

Timeframe: Baseline and Day 28

Population: Per protocol (PP)

Assessed by digital ocular photography; the quadrant with the pterygium will be scored using a 5-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe) and graded by a reading center. Assessments are made by subtracting the score at Baseline from the score on Day 28. An increase in value indicates worsening of hyperemia, while a decrease indicates improvement.

Outcome measures

Outcome measures
Measure	Vehicle Eye Drops n=18 Participants One drop, three times daily to the study eye for 28 days Vehicle Eye Drops: One drop, three times daily to the study eye for 28 days	0.1% AG-86893 Eye Drops n=21 Participants One drop, three times daily to the study eye for 28 days 0.1% AG-86893 Eye Drops: One drop, three times daily to the study eye for 28 days	0.3% AG-86893 Eye Drops n=22 Participants One drop, three times daily to the study eye for 28 days 0.3% AG-86893 Eye Drops: One drop, three times daily to the study eye for 28 days
Change From Baseline in Conjunctival Hyperemia Score in the Quadrant With the Pterygium	-0.111 score on a scale Standard Error 0.153	-0.429 score on a scale Standard Error 0.142	-0.500 score on a scale Standard Error 0.138

POST_HOC outcome

Timeframe: Day 28

Population: Per protocol (PP)

Assessed by digital ocular photography; the quadrant with the pterygium will be scored using a 5-point scale and graded by a reading center. A 1-point reduction in hyperemia score is considered clinically meaningful.

Outcome measures

Outcome measures
Measure	Vehicle Eye Drops n=18 Participants One drop, three times daily to the study eye for 28 days Vehicle Eye Drops: One drop, three times daily to the study eye for 28 days	0.1% AG-86893 Eye Drops n=21 Participants One drop, three times daily to the study eye for 28 days 0.1% AG-86893 Eye Drops: One drop, three times daily to the study eye for 28 days	0.3% AG-86893 Eye Drops n=22 Participants One drop, three times daily to the study eye for 28 days 0.3% AG-86893 Eye Drops: One drop, three times daily to the study eye for 28 days
Percent of Patients With a 1-point Decrease in Hyperemia Score in the Quadrant With the Pterygium	3 Participants	11 Participants	12 Participants

Adverse Events

Vehicle Eye Drops

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

0.1% AG-86893 Eye Drops

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

0.3% AG-86893 Eye Drops

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Tan Nguyen

Allgenesis Biotherapeutics

Phone: +886-2-8787-1232

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Vehicle Eye Drops n=20 participants at risk One drop, three times daily to the study eye for 28 days Vehicle Eye Drops: One drop, three times daily to the study eye for 28 days	0.1% AG-86893 Eye Drops n=22 participants at risk One drop, three times daily to the study eye for 28 days 0.1% AG-86893 Eye Drops: One drop, three times daily to the study eye for 28 days	0.3% AG-86893 Eye Drops n=22 participants at risk One drop, three times daily to the study eye for 28 days 0.3% AG-86893 Eye Drops: One drop, three times daily to the study eye for 28 days
Eye disorders Conjunctival Discoloration	0.00% 0/20 • Adverse events were monitored for each patient until Day 84 (exit).	4.5% 1/22 • Adverse events were monitored for each patient until Day 84 (exit).	45.5% 10/22 • Adverse events were monitored for each patient until Day 84 (exit).
Eye disorders Vision blurred	5.0% 1/20 • Adverse events were monitored for each patient until Day 84 (exit).	4.5% 1/22 • Adverse events were monitored for each patient until Day 84 (exit).	18.2% 4/22 • Adverse events were monitored for each patient until Day 84 (exit).
Eye disorders Dry eye	0.00% 0/20 • Adverse events were monitored for each patient until Day 84 (exit).	0.00% 0/22 • Adverse events were monitored for each patient until Day 84 (exit).	9.1% 2/22 • Adverse events were monitored for each patient until Day 84 (exit).
Eye disorders Eye pruritis	5.0% 1/20 • Adverse events were monitored for each patient until Day 84 (exit).	9.1% 2/22 • Adverse events were monitored for each patient until Day 84 (exit).	0.00% 0/22 • Adverse events were monitored for each patient until Day 84 (exit).
Eye disorders Eye pain	5.0% 1/20 • Adverse events were monitored for each patient until Day 84 (exit).	0.00% 0/22 • Adverse events were monitored for each patient until Day 84 (exit).	4.5% 1/22 • Adverse events were monitored for each patient until Day 84 (exit).
Eye disorders Ocular hyperaemia	5.0% 1/20 • Adverse events were monitored for each patient until Day 84 (exit).	0.00% 0/22 • Adverse events were monitored for each patient until Day 84 (exit).	0.00% 0/22 • Adverse events were monitored for each patient until Day 84 (exit).
Eye disorders Blepharitis	5.0% 1/20 • Adverse events were monitored for each patient until Day 84 (exit).	0.00% 0/22 • Adverse events were monitored for each patient until Day 84 (exit).	0.00% 0/22 • Adverse events were monitored for each patient until Day 84 (exit).
Eye disorders Episcleritis	5.0% 1/20 • Adverse events were monitored for each patient until Day 84 (exit).	0.00% 0/22 • Adverse events were monitored for each patient until Day 84 (exit).	0.00% 0/22 • Adverse events were monitored for each patient until Day 84 (exit).
Eye disorders Lacrimation increased	10.0% 2/20 • Adverse events were monitored for each patient until Day 84 (exit).	4.5% 1/22 • Adverse events were monitored for each patient until Day 84 (exit).	0.00% 0/22 • Adverse events were monitored for each patient until Day 84 (exit).
Eye disorders Visual impairment	5.0% 1/20 • Adverse events were monitored for each patient until Day 84 (exit).	0.00% 0/22 • Adverse events were monitored for each patient until Day 84 (exit).	0.00% 0/22 • Adverse events were monitored for each patient until Day 84 (exit).
Ear and labyrinth disorders Influenza	5.0% 1/20 • Adverse events were monitored for each patient until Day 84 (exit).	0.00% 0/22 • Adverse events were monitored for each patient until Day 84 (exit).	0.00% 0/22 • Adverse events were monitored for each patient until Day 84 (exit).
Ear and labyrinth disorders Nasopharyngitis	5.0% 1/20 • Adverse events were monitored for each patient until Day 84 (exit).	0.00% 0/22 • Adverse events were monitored for each patient until Day 84 (exit).	0.00% 0/22 • Adverse events were monitored for each patient until Day 84 (exit).
Ear and labyrinth disorders Pneumonia	5.0% 1/20 • Adverse events were monitored for each patient until Day 84 (exit).	0.00% 0/22 • Adverse events were monitored for each patient until Day 84 (exit).	0.00% 0/22 • Adverse events were monitored for each patient until Day 84 (exit).
Ear and labyrinth disorders Viral upper respiratory tract infection	5.0% 1/20 • Adverse events were monitored for each patient until Day 84 (exit).	0.00% 0/22 • Adverse events were monitored for each patient until Day 84 (exit).	0.00% 0/22 • Adverse events were monitored for each patient until Day 84 (exit).
Skin and subcutaneous tissue disorders Dermatitis allergic	5.0% 1/20 • Adverse events were monitored for each patient until Day 84 (exit).	0.00% 0/22 • Adverse events were monitored for each patient until Day 84 (exit).	0.00% 0/22 • Adverse events were monitored for each patient until Day 84 (exit).