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

Primary Purpose

Pterygium

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
0.1% AG-86893 Eye Drops
0.3% AG-86893 Eye Drops
Vehicle Eye Drops
Sponsored by
Allgenesis Biotherapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pterygium focused on measuring Hyperemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • M.T. Coroneo Pty Ltd
  • H2Vision Centre
  • Bendigo Eye Clinic
  • Essendon Eye Clinic
  • The Geelong Eye Centre
  • Lions Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Vehicle Eye Drops

0.1% AG-86893 Eye Drops

0.3% AG-86893 Eye Drops

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 27, 2018
Last Updated
November 4, 2020
Sponsor
Allgenesis Biotherapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03533244
Brief Title
A Study of the Response to AG-86893 in Patients With Pterygium Hyperemia
Acronym
SURPH
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 11, 2018 (Actual)
Primary Completion Date
September 5, 2019 (Actual)
Study Completion Date
October 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allgenesis Biotherapeutics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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 At least 1 concentration of AG-86893 is effective, as measured by the mean change from baseline in conjunctival hyperemia (redness), compared with vehicle

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium
Keywords
Hyperemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vehicle Eye Drops
Arm Type
Placebo Comparator
Arm Description
One drop, three times daily to the study eye for 28 days
Arm Title
0.1% AG-86893 Eye Drops
Arm Type
Experimental
Arm Description
One drop, three times daily to the study eye for 28 days
Arm Title
0.3% AG-86893 Eye Drops
Arm Type
Experimental
Arm Description
One drop, three times daily to the study eye for 28 days
Intervention Type
Drug
Intervention Name(s)
0.1% AG-86893 Eye Drops
Intervention Description
One drop, three times daily to the study eye for 28 days
Intervention Type
Drug
Intervention Name(s)
0.3% AG-86893 Eye Drops
Intervention Description
One drop, three times daily to the study eye for 28 days
Intervention Type
Drug
Intervention Name(s)
Vehicle Eye Drops
Intervention Description
One drop, three times daily to the study eye for 28 days
Primary Outcome Measure Information:
Title
Change From Baseline in Overall Conjunctival Hyperemia Score
Description
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
Secondary Outcome Measure Information:
Title
Change From Baseline in Conjunctival Hyperemia Score in the Quadrant With the Pterygium
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
M.T. Coroneo Pty Ltd
City
Randwick
State/Province
New South Wales
Country
Australia
Facility Name
H2Vision Centre
City
Sippy Downs
State/Province
Queensland
Country
Australia
Facility Name
Bendigo Eye Clinic
City
Bendigo
State/Province
Victoria
Country
Australia
Facility Name
Essendon Eye Clinic
City
Essendon
State/Province
Victoria
Country
Australia
Facility Name
The Geelong Eye Centre
City
Waurn Ponds
State/Province
Victoria
Country
Australia
Facility Name
Lions Eye Institute
City
Nedlands
State/Province
Western Australia
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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