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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03533244
Registration number
NCT03533244
Ethics application status
Date submitted
27/04/2018
Date registered
23/05/2018
Date last updated
6/11/2020
Titles & IDs
Public title
A Study of the Response to AG-86893 in Patients With Pterygium Hyperemia
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Scientific title
A Multicenter, Prospective, Randomized, Double-Masked, Phase 2 Study Evaluating the Safety, Tolerability, and Efficacy of Topical AG-86893 in Patients With Pterygium
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Secondary ID [1]00
P2-86893-001
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Universal Trial Number (UTN)
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Trial acronym
SURPH
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pterygium00
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Condition category
Condition code
Eye0000
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - 0.1% AG-86893 Eye Drops Placebo Comparator: 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 Experimental: 0.3% AG-86893 Eye Drops - One drop, three times daily to the study eye for 28 days Treatment: Drugs: 0.1% AG-86893 Eye Drops Treatment: Drugs: 0.3% AG-86893 Eye Drops Treatment: Drugs: Vehicle Eye Drops
Treatment: Drugs - 0.3% AG-86893 Eye Drops
Treatment: Drugs - Vehicle Eye Drops
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
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Intervention code [1]00
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]00
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.
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Secondary outcome [1]00
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.
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Timepoint [1]00
Baseline and Day 28
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Eligibility
Key inclusion criteria
- Good health with no clinically significant findings based on the medical history, - Females of childbearing potential must have a negative pregnancy test at baseline and - Presence of pterygium with associated conjunctival hyperemia (redness) of grade =2 as
electrocardiogram, vital signs, blood chemistry, hematology, and urinalysis findings,
as determined by the investigator
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.
assessed by a central reading center.
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Minimum age
18Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- History or presence of any ocular diseases other than pterygium or its sequelae - Diagnosis of ocular hypertension or glaucoma requiring use of intraocular - 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
(after-effects), including neoplasia (uncontrolled overgrowth)
pressure-lowering medication
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealmentprocedures)
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Methods used to generate the sequence in which subjects will be randomised (sequencegeneration)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/10/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
25/10/2019
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Sample size
Target
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Accrual to date
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Final
64
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]00
M.T. Coroneo Pty Ltd - Randwick
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Recruitment hospital [2]00
H2Vision Centre - Sippy Downs
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Recruitment hospital [3]00
Bendigo Eye Clinic - Bendigo
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Recruitment hospital [4]00
Essendon Eye Clinic - Essendon
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Recruitment hospital [5]00
The Geelong Eye Centre - Waurn Ponds
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Recruitment hospital [6]00
Lions Eye Institute - Nedlands
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Recruitment postcode(s) [1]00
- Randwick
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Recruitment postcode(s) [2]00
- Sippy Downs
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Recruitment postcode(s) [3]00
- Bendigo
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Recruitment postcode(s) [4]00
- Essendon
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Recruitment postcode(s) [5]00
- Waurn Ponds
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Recruitment postcode(s) [6]00
- Nedlands
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Allgenesis Biotherapeutics Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
A pterygium is a wing-shaped, benign tissue growth which forms on the surface of the Hypothesis 1. AG-86893 dosed three times daily for 28 consecutive days has an acceptable safety 2. At least 1 concentration of AG-86893 is effective, as measured by the mean change from
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.
profile as measured by the incidence and severity of adverse events (AEs) compared with
vehicle
baseline in conjunctival hyperemia (redness), compared with vehicle
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03533244
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name00
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Address00
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Country00
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Phone00
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Fax00
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Email00
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Contact person for public queries
Name00
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Address00
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Country00
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Phone00
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Email00
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Contact person for scientific queries
Summary results
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Other publications
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