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

Allgenesis Biotherapeutics

Status and phase: Completed; Phase 2

Conditions: Pterygium

Treatments: Drug: 0.3% AG-86893 Eye Drops; Drug: Vehicle Eye Drops; Drug: 0.1% AG-86893 Eye Drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT03533244

P2-86893-001

Details and patient eligibility

About

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

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 3 patient groups, including a placebo group

Vehicle Eye Drops

Placebo Comparator group

Description:

One drop, three times daily to the study eye for 28 days

Treatment:

Drug: Vehicle Eye Drops

0.1% AG-86893 Eye Drops

Experimental group

Description:

One drop, three times daily to the study eye for 28 days

Treatment:

Drug: 0.1% AG-86893 Eye Drops

0.3% AG-86893 Eye Drops

Experimental group

Description:

One drop, three times daily to the study eye for 28 days

Treatment:

Drug: 0.3% AG-86893 Eye Drops