PterygiumPhase 2SURPHNCT03533244
A Study of the Response to AG-86893 in Patients With Pterygium Hyperemia
A Phase 2 study testing 0.1% AG-86893 Eye Drops and 0.3% AG-86893 Eye Drops in people with Pterygium, run by Allgenesis Biotherapeutics Inc. at 6 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pterygium
- What is being tested?
- 0.1% AG-86893 Eye Drops and 0.3% AG-86893 Eye Drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 6 sitesAustralia
- Study dates
- 11 Oct 2018to 25 Oct 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
Australia6 sites
Bendigo Eye Clinic
Bendigo, Victoria
Essendon Eye Clinic
Essendon, Victoria
Lions Eye Institute
Nedlands, Western Australia
M.T. Coroneo Pty Ltd
Randwick, New South Wales
H2Vision Centre
Sippy Downs, Queensland
The Geelong Eye Centre
Waurn Ponds, Victoria
About this study
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
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
- Conditions
- Pterygium
- Being tested
- 0.1% AG-86893 Eye Drops, 0.3% AG-86893 Eye Drops, Vehicle Eye Drops
- Keywords
- Hyperemia
- Medical subject headings
- Pterygium, Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.1% AG-86893 Eye DropsDrug
One drop, three times daily to the study eye for 28 days
0.3% AG-86893 Eye DropsDrug
One drop, three times daily to the study eye for 28 days
Vehicle Eye DropsDrug
One drop, three times daily to the study eye for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Vehicle Eye Drops | Placebo comparator | One drop, three times daily to the study eye for 28 days Receives: Drug: Vehicle Eye Drops |
| 0.1% AG-86893 Eye Drops | Experimental | One drop, three times daily to the study eye for 28 days Receives: 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 Receives: Drug: 0.3% AG-86893 Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Day 28
Secondary outcomes (1)
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.
Measured: Baseline and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start11 Oct 2018
- Primary completion5 Sep 2019
- Study completion25 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PterygiumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allgenesis Biotherapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533244
- Sponsor's protocol ID
- P2-86893-001
- Acronym
- SURPH
- Status last verified
- Jan 2020
- First submitted
- 27 Apr 2018
- Last updated
- 6 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03533244
- Acronym / sponsor ID
- SURPH / P2-86893-001
- Conditions
- Pterygium
- Keywords
- Hyperemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Allgenesis Biotherapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Oct 2018 (actual)
- Primary completion
- 5 Sep 2019 (actual)
- Study completion
- 25 Oct 2019 (actual)
- First posted
- 23 May 2018 (actual)
- Results
- Posted 6 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vehicle Eye Drops | Placebo comparator | Drug: Vehicle Eye DropsOne drop, three times daily to the study eye for 28 days |
| 0.1% AG-86893 Eye Drops | Experimental | Drug: 0.1% AG-86893 Eye DropsOne drop, three times daily to the study eye for 28 days |
| 0.3% AG-86893 Eye Drops | Experimental | Drug: 0.3% AG-86893 Eye DropsOne drop, three times daily to the study eye for 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.1% AG-86893 Eye DropsOne drop, three times daily to the study eye for 28 days | Drug | 0.1% AG-86893 Eye Drops |
| 0.3% AG-86893 Eye DropsOne drop, three times daily to the study eye for 28 days | Drug | 0.3% AG-86893 Eye Drops |
| Vehicle Eye DropsOne drop, three times daily to the study eye for 28 days | Drug | Vehicle Eye Drops |
Primary outcome
Change From Baseline in Overall Conjunctival Hyperemia Score
Time frame: Baseline and Day 28
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.
1 secondary outcome
Change From Baseline in Conjunctival Hyperemia Score in the Quadrant With the Pterygium
Time frame: Baseline and Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.1% AG-86893 Eye Drops and 0.3% AG-86893 Eye Drops in people with Pterygium, run by Allgenesis Biotherapeutics Inc. at 6 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Overall Conjunctival Hyperemia Score (time frame: Baseline and Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.