Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03533244
Recruitment Status : Completed
First Posted : May 23, 2018
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Allgenesis Biotherapeutics Inc.

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. 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

Condition or disease Intervention/treatment Phase
Pterygium Drug: 0.1% AG-86893 Eye Drops Drug: 0.3% AG-86893 Eye Drops Drug: Vehicle Eye Drops Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 11, 2018
Actual Primary Completion Date : September 5, 2019
Actual Study Completion Date : October 25, 2019

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




Primary Outcome Measures :
  1. Change from baseline in overall conjunctival hyperemia score [ Time Frame: 28 Days ]
    Assessed by digital ocular photography; each quadrant will be scored using a 5-point scale and graded by a reading center. The overall conjunctival score is the average of the score of each quadrant.


Secondary Outcome Measures :
  1. Change from baseline in overall conjunctival hyperemia score [ Time Frame: 7 (optional) and 56 Days ]
    Assessed by digital ocular photography; each quadrant will be scored using a 5-point scale and graded by a reading center. The overall conjunctival score is the average of the score of each quadrant.

  2. Change from baseline in conjunctival hyperemia score in the quadrant with the pterygium [ Time Frame: 7 (optional), 28, and 56 Days ]
    Assessed by digital ocular photography; the quadrant with the pterygium will be scored using a 5-point scale and graded by a reading center.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03533244


Locations
Layout table for location information
Australia, New South Wales
M.T. Coroneo Pty Ltd
Randwick, New South Wales, Australia
Australia, Queensland
H2Vision Centre
Sippy Downs, Queensland, Australia
Australia, Victoria
Bendigo Eye Clinic
Bendigo, Victoria, Australia
Essendon Eye Clinic
Essendon, Victoria, Australia
The Geelong Eye Centre
Waurn Ponds, Victoria, Australia
Australia, Western Australia
Lions Eye Institute
Nedlands, Western Australia, Australia
Sponsors and Collaborators
Allgenesis Biotherapeutics Inc.

Layout table for additonal information
Responsible Party: Allgenesis Biotherapeutics Inc.
ClinicalTrials.gov Identifier: NCT03533244    
Other Study ID Numbers: P2-86893-001
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Allgenesis Biotherapeutics Inc.:
Hyperemia
Additional relevant MeSH terms:
Layout table for MeSH terms
Pterygium
Conjunctival Diseases
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions