Clinical trial NCT03533244: A Study of the Response to AG-86893 in Patients With Pterygium Hyperemia
Official title: A Multicenter, Prospective, Randomized, Double-Masked, Phase 2 Study Evaluating the Safety, Tolerability, and Efficacy of Topical AG-86893 in Patients With Pterygium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pterygium
Keywords: Hyperemia
Lead sponsor: Allgenesis Biotherapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2018-05-23
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

1. AG-86893 dosed three times daily for 28 consecutive days has an acceptable safety profile as measured by the incidence and severity of adverse events (AEs) compared with vehicle
2. At least 1 concentration of AG-86893 is effective, as measured by the mean change from baseline in conjunctival hyperemia (redness), compared with vehicle


Eligibility criteria: Inclusion Criteria:

* Good health with no clinically significant findings based on the medical history, electrocardiogram, vital signs, blood chemistry, hematology, and urinalysis findings, as determined by the investigator
* Females of childbearing potential must have a negative pregnancy test at baseline and must be on established, adequate contraception and males must use condoms if their partner is of childbearing potential and their female partner should also use an additional effective means of contraception, or they must agree to abstain from sexual intercourse with a female partner for the duration of the study; contraception should be continued for 3 months after the last dose.
* Presence of pterygium with associated conjunctival hyperemia (redness) of grade ≥2 as assessed by a central reading center.

Exclusion Criteria:

* History or presence of any ocular diseases other than pterygium or its sequelae (after-effects), including neoplasia (uncontrolled overgrowth)
* Diagnosis of ocular hypertension or glaucoma requiring use of intraocular pressure-lowering medication
* Use of contact lenses during the study in the study eye
* History or evidence of ocular surgeries in the study eye at any time
* History of liver dysfunction or current abnormal liver enzymes
* Pregnancy, plans for pregnancy, or breastfeeding during the study

Primary outcomes:
measure: Change From Baseline in Overall Conjunctival Hyperemia Score
timeFrame: Baseline and Day 28
Secondary outcomes:
measure: Change From Baseline in Conjunctival Hyperemia Score in the Quadrant With the Pterygium
timeFrame: Baseline and Day 28
Other outcomes:
Locations:
city: Randwick
country: Australia
facility: M.T. Coroneo Pty Ltd
state: New South Wales
city: Sippy Downs
country: Australia
facility: H2Vision Centre
state: Queensland
city: Bendigo
country: Australia
facility: Bendigo Eye Clinic
state: Victoria
city: Essendon
country: Australia
facility: Essendon Eye Clinic
state: Victoria
city: Waurn Ponds
country: Australia
facility: The Geelong Eye Centre
state: Victoria
city: Nedlands
country: Australia
facility: Lions Eye Institute
state: Western Australia
Study officials:
References: