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

A Multicenter, Prospective, Randomized, Double-Masked, Phase 2 Study Evaluating the Safety, Tolerability, and Efficacy of Topical AG-86893 in Patients With Pterygium

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

Study Overview

• Status: Completed
• Conditions: Pterygium
• Intervention / Treatment: Drug: Vehicle Eye Drops; Drug: 0.1% AG-86893 Eye Drops; Drug: 0.3% AG-86893 Eye Drops

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Randwick, New South Wales, Australia
      • M.T. Coroneo Pty Ltd
  • Queensland
    • Sippy Downs, Queensland, Australia
      • H2Vision Centre
  • Victoria
    • Bendigo, Victoria, Australia
      • Bendigo Eye Clinic
    • Essendon, Victoria, Australia
      • Essendon Eye Clinic
    • Waurn Ponds, Victoria, Australia
      • The Geelong Eye Centre
  • Western Australia
    • Nedlands, Western Australia, Australia
      • Lions Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle Eye Drops; 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
Experimental: 0.1% AG-86893 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
Experimental: 0.3% 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Day 28

Collaborators and Investigators

• Sponsor: Allgenesis Biotherapeutics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2018
• Primary Completion (Actual): September 5, 2019
• Study Completion (Actual): October 25, 2019

Study Registration Dates

• First Submitted: April 27, 2018
• First Submitted That Met QC Criteria: May 10, 2018
• First Posted (Actual): May 23, 2018

Study Record Updates

• Last Update Posted (Actual): November 6, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Hyperemia
• Additional Relevant MeSH Terms: Eye Diseases; Conjunctival Diseases; Pterygium; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: P2-86893-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No