A Phase 2 interventional study of 0.1% AG-86893 Eye Drops and 0.3% AG-86893 Eye Drops in Pterygium, sponsored by Allgenesis Biotherapeutics Inc.. Completed at 6 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-06.
Sponsored by Allgenesis Biotherapeutics Inc. · Phase 2, Interventional, and Treatment
A pterygium is a wing-shaped, benign tissue growth which forms on the surface of the conjunctiva and grows towards the cornea. It can eventually lead to vision impairment. The precise cause of pterygium formation is unknown but new blood vessel growth and fibroblastic structures are characteristics of the disease. AG-86893 is an eye drop being developed to treat hyperemia (redness) and growth of the pterygium.
Hypothesis
109 studies on the registry are indexed under Pterygium; 9 are open to participants now.
This study's enrollment of 64 is close to the median of 60 across 93 interventional studies indexed under Pterygium.
Browse Pterygium studies →Allgenesis Biotherapeutics Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One drop, three times daily to the study eye for 28 days
Drug: Vehicle Eye Drops
One drop, three times daily to the study eye for 28 days
Drug: 0.1% AG-86893 Eye Drops
One drop, three times daily to the study eye for 28 days
Drug: 0.3% AG-86893 Eye Drops
One drop, three times daily to the study eye for 28 days
One drop, three times daily to the study eye for 28 days
One drop, three times daily to the study eye for 28 days
Change From Baseline in Overall Conjunctival Hyperemia Score
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.
Time frame: Baseline and Day 28
Change From Baseline in Conjunctival Hyperemia Score in the Quadrant With the Pterygium
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.
Time frame: Baseline and Day 28
| Milestone | Vehicle Eye Drops | 0.1% AG-86893 Eye Drops | 0.3% AG-86893 Eye Drops |
|---|---|---|---|
| Started | 20 | 22 | 22 |
| Completed | 18 | 21 | 22 |
| Not completed | 2 | 1 | 0 |
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.
| score on a scale | Vehicle Eye Drops | 0.1% AG-86893 Eye Drops | 0.3% AG-86893 Eye Drops |
|---|---|---|---|
| Change From Baseline in Overall Conjunctival Hyperemia Score | -0.056 ± 0.120 | -0.330 ± 0.109 | -0.352 ± 0.109 |
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.
| score on a scale | Vehicle Eye Drops | 0.1% AG-86893 Eye Drops | 0.3% AG-86893 Eye Drops |
|---|---|---|---|
| Change From Baseline in Conjunctival Hyperemia Score in the Quadrant With the Pterygium | -0.111 ± 0.153 | -0.429 ± 0.142 | -0.500 ± 0.138 |
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.
| Participants | Vehicle Eye Drops | 0.1% AG-86893 Eye Drops | 0.3% AG-86893 Eye Drops |
|---|---|---|---|
| Percent of Patients With a 1-point Decrease in Hyperemia Score in the Quadrant With the Pterygium | 3 | 11 | 12 |
Collected over Adverse events were monitored for each patient until Day 84 (exit).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vehicle Eye Drops | 0/20 (0%) | 0/20 (0%) | 5/20 (25%) |
| 0.1% AG-86893 Eye Drops | 0/22 (0%) | 0/22 (0%) | 5/22 (22.7%) |
| 0.3% AG-86893 Eye Drops | 0/22 (0%) | 0/22 (0%) | 15/22 (68.2%) |
| Event | Vehicle Eye Drops | 0.1% AG-86893 Eye Drops | 0.3% AG-86893 Eye Drops |
|---|---|---|---|
| Conjunctival DiscolorationEye disorders | 0/20 | 1/22 | 10/22 |
| Vision blurredEye disorders | 1/20 | 1/22 | 4/22 |
| Lacrimation increasedEye disorders | 2/20 | 1/22 | 0/22 |
| Dry eyeEye disorders | 0/20 | 0/22 | 2/22 |
| Eye pruritisEye disorders | 1/20 | 2/22 | 0/22 |
| Eye painEye disorders | 1/20 | 0/22 | 1/22 |
| Ocular hyperaemiaEye disorders | 1/20 | 0/22 | 0/22 |
| BlepharitisEye disorders | 1/20 | 0/22 | 0/22 |
| EpiscleritisEye disorders | 1/20 | 0/22 | 0/22 |
| Visual impairmentEye disorders | 1/20 | 0/22 | 0/22 |
| Age, Continuous(years) | Vehicle Eye Drops | 0.1% AG-86893 Eye Drops | 0.3% AG-86893 Eye Drops | Total |
|---|---|---|---|---|
| Mean | 49.8 ± 12.4 | 54.7 ± 11.9 | 49.0 ± 10.7 | 51.2 ± 11.8 |
| Sex: Female, Male(Participants) | Vehicle Eye Drops | 0.1% AG-86893 Eye Drops | 0.3% AG-86893 Eye Drops | Total |
|---|---|---|---|---|
| Female | 10 | 5 | 11 | 26 |
| Male | 10 | 17 | 11 | 38 |
| Race (NIH/OMB)(Participants) | Vehicle Eye Drops | 0.1% AG-86893 Eye Drops | 0.3% AG-86893 Eye Drops | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 18 | 21 | 19 | 58 |
| More than one race | 1 | 0 | 0 | 1 |
| Unknown or Not Reported | 1 | 0 | 2 | 3 |
| Region of Enrollment(Participants) | Vehicle Eye Drops | 0.1% AG-86893 Eye Drops | 0.3% AG-86893 Eye Drops | Total |
|---|---|---|---|---|
| Australia | 20 | 22 | 22 | 64 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2018 to primary completion in Sep 2019, 10 months.
Results were first posted in Nov 2020, 1 year 2 months after primary completion.
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Allgenesis Biotherapeutics Inc.