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

NCT03533244 | Completed Phase 2 Results FDA Drug

• 1 other identifier: P2-86893-001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 6

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. 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. 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

Conditions

Pterygium

Keywords

Hyperemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change From Baseline in Conjunctival Hyperemia Score in the Quadrant With the Pterygium

  Baseline and Day 28

Study Arms (3)

Vehicle Eye Drops

PLACEBO COMPARATOR

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

Drug: Vehicle Eye Drops

0.1% AG-86893 Eye Drops

EXPERIMENTAL

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

Drug: 0.1% AG-86893 Eye Drops

0.3% AG-86893 Eye Drops

EXPERIMENTAL

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

Drug: 0.3% AG-86893 Eye Drops

Interventions

0.1% AG-86893 Eye Drops DRUG

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

0.1% AG-86893 Eye Drops

0.3% AG-86893 Eye Drops DRUG

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

0.3% AG-86893 Eye Drops

Vehicle Eye Drops DRUG

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

Vehicle Eye Drops

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Allgenesis Biotherapeutics Inc.: lead

Study Sites (6)

M.T. Coroneo Pty Ltd

Randwick, New South Wales, Australia

Location

H2Vision Centre

Sippy Downs, Queensland, Australia

Location

Bendigo Eye Clinic

Bendigo, Victoria, Australia

Location

Essendon Eye Clinic

Essendon, Victoria, Australia

Location

The Geelong Eye Centre

Waurn Ponds, Victoria, Australia

Location

Lions Eye Institute

Nedlands, Western Australia, Australia

Location

MeSH Terms

Conditions

Pterygium; Hyperemia

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Tan Nguyen
• Organization: Allgenesis Biotherapeutics

tan.nguyen@allgenesis.com

+886-2-8787-1232

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: May 23, 2018
• Study Start: October 11, 2018
• Primary Completion: September 5, 2019
• Study Completion: October 25, 2019
• Last Updated: November 6, 2020
• Results First Posted: November 6, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (6)