RECRUITING

AGN-193408 SR in the Treatment of Open-angle Glaucoma or Ocular Hypertension

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Conditions

Open-angle GlaucomaOcular Hypertension

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a multicenter, open-label, dose escalation (Cohort 1) to masked, randomized, parallel-groups (Cohort 2) and (Cohort 3) study to evaluate the safety and efficacy of AGN-193408 SR in participants with open-angle glaucoma or ocular hypertension

Official Title

A Phase 1/2 Study to Evaluate the Safety and Efficacy of AGN-193408 SR in Participants With Open-Angle Glaucoma or Ocular Hypertension

Quick Facts

Study Start:2020-11-16
Study Completion:2028-08-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04499248

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant is willing to withhold his/her IOP (Intraocular Pressure) treatments according to the study requirements, and in the opinion of the investigator, can do so without significant risk.
  2. * Diagnosis of either OAG \[open-angle glaucoma\] (ie, \[POAG\], pseudoexfoliation glaucoma,pigmentary glaucoma) or OHT (ocular hypertension) in both eyes.
  3. * Must be pseudophakic (at least 4 months postcataract surgery prior to treatment administration \[Cycle 1 Day 1 Administration visit\]) (Cohort 3 only).
  1. * Known allergy or sensitivity to any study medication or its components, any component of the delivery vehicle, procedure-related materials, or diagnostic agents used during the study (eg, topical anesthetic, dilating drops, fluorescein, povidone-iodine).
  2. * Concurrent or anticipated enrollment in an investigational drug or device study or participation in such a study within 2 months prior to the Baseline visit through the final study visit.
  3. * History of intracameral implant in the study eye (eg, Bimatoprost SR, OTX-TIC, ENV515 Travoprost XR).
  4. * History of laser trabeculoplasty within 6 months prior to screening in the study eye.
  5. * History or evidence of clinically relevant, substantial ocular trauma (eg, a traumatic cataract, traumatic angle recession, etc.) in the study eye.
  6. * History or evidence of complicated cataract/lens surgery, as stated in the protocol.
  7. * Intraocular surgery (including cataract surgery) in the study eye within the 4 months prior to treatment administration.
  8. * Any history of corneal graft, including partial grafts (eg, Descemet's Stripping Endothelial Keratoplasty \[DSEK\], Descemet's Membrane Endothelial Keratoplasty \[DMEK\]); or incisional refractive surgery (eg, radial keratotomy), other than astigmatic keratotomy or limbal relaxing incisions in the study eye.
  9. * History of herpetic ocular diseases in either eye (including herpes simplex virus and varicella zoster virus).
  10. * Anticipated need for any incisional or laser ocular surgery in either eye during the study.
  11. * History of anatomically narrow angle resulting in evidence of angle changes or any history or closed angle glaucoma in the study eye.
  12. * History or evidence of a peripheral iridotomy/iridectomy in the inferior iris in the study eye.
  13. * Any history of trabeculectomy or other types of incisional glaucoma surgery, including a glaucoma seton or aqueous bypass stents in either eye, or minimally invasive glaucoma surgery (MIGS) type trabecular meshwork surgeries in the study eye.
  14. * Anticipated use of corticosteroids in either eye except for permitted interventions or systemically during the study, or historical use prior to Baseline within:
  15. * 3 years: intraocular fluocinolone acetonide
  16. * 6 months: intraocular corticosteroid(s) other than fluocinolone; any injectable periocular or sub-Tenon's/subconjunctival corticosteroid
  17. * 2 months: systemic (eg, oral, intramuscular, intravenous) or topical ocular corticosteroids
  18. * 2 weeks: dermal corticosteroids applied to skin of the eyelid(s), around the eye, or adnexa.
  19. * Anticipated use of other topical ocular medications in either eye except for permitted interventions.
  20. * The anticipated wearing of contact lenses in the study eye (Cohort 1) and both eyes (Cohorts 2 and 3) during the study that deviates from the following (contact lens wear is allowed during the study, but is to be temporarily discontinued before study visits, and before and after an Administration Day according to the following):
  21. * Use of soft lenses should be discontinued at least 3 days prior to Baseline, and use of rigid gas permeable or hard contact lenses should be discontinued at least 1 week prior to Baseline
  22. * Use of soft lenses should be discontinued at least 3 days and use of rigid gas permeable or hard contact lenses should be discontinued at least 1 week prior to a scheduled study visit or Administration Day visit
  23. * Use of contact lenses of any kind should be discontinued for 1 week following any AGN-193408 SR administration
  24. * Central corneal thickness of \< 480 or \> 620 micrometers in both eyes.
  25. * Visual field loss in the study eye that, in the opinion of the investigator, is functionally significant (eg, split fixation, field defect within the central 10 degrees that is visually significant or likely to cause central visual impairment upon progression) or shows evidence of progressive visual field loss within the year prior to Baseline.
  26. * Evidence of macular edema in either eye during screening or in participant's medical history.
  27. * At Screening, evidence of posterior synechia behind the iris inferiorly in the study eye that in the investigator's opinion may inhibit the ability to safely receive at least 1 AGN-193408 SR implant (Cohort 3 only).

Contacts and Locations

Study Contact

ABBVIE CALL CENTER
CONTACT
844-663-3742
abbvieclinicaltrials@abbvie.com

Principal Investigator

ABBVIE INC.
STUDY_DIRECTOR
AbbVie

Study Locations (Sites)

Walman Eye Center /ID# 252153
Sun City, Arizona, 85351
United States
Global Research Management /ID# 241699
Glendale, California, 91204-2500
United States
United Medical Research Institute /ID# 241701
Inglewood, California, 90301
United States
Lakeside Vision Center /ID# 241698
Irvine, California, 92604
United States
The Eye Research Foundation /ID# 234528
Newport Beach, California, 92663-3637
United States
Sacramento Eye Consultants /ID# 241697
Sacramento, California, 95815
United States
Premiere Practice Management LLC /ID# 235957
Torrance, California, 90505
United States
Wolstan & Goldberg Eye Associates /ID# 241700
Torrance, California, 90505
United States
Connecticut Eye Consultants P.C. /ID# 235862
Danbury, Connecticut, 06810
United States
Nature Coast Clinical Research - Crystal River /ID# 237781
Crystal River, Florida, 34429
United States
University of Florida Health Ophthalmology - Jacksonville /ID# 243122
Jacksonville, Florida, 32209-6533
United States
East Florida Eye Institute /ID# 235762
Stuart, Florida, 34994
United States
Logan Ophthalmic Research Inc. /ID# 252087
Tamarac, Florida, 33321
United States
Coastal Research Associates /ID# 234649
Roswell, Georgia, 30076
United States
Midwest Medical Advisors Inc /ID# 235845
Carmel, Indiana, 46290
United States
Indiana University - Glick Eye Institute /ID# 235887
Indianapolis, Indiana, 46202
United States
Ophthalmic Consultants of Boston /ID# 236535
Boston, Massachusetts, 02129
United States
Fraser Eye Care Center /ID# 267100
Fraser, Michigan, 48026
United States
Midwest Vision Research Foundation at Pepose Vision Institute /ID# 267094
Chesterfield, Missouri, 63017
United States
Silverstein Eye Centers /ID# 266767
Kansas City, Missouri, 64133
United States
Tekwani Vision Center /ID# 235149
Saint Louis, Missouri, 63128
United States
Rutgers New Jersey Medical School Campus, Doctors Office Center /ID# 234365
Newark, New Jersey, 07103-2425
United States
Northern New Jersey Eye Institute PA /ID# 241545
South Orange, New Jersey, 07079-1855
United States
Asheville Eye Associates /ID# 234963
Asheville, North Carolina, 28803
United States
James D Branch MD /ID# 234560
Winston-Salem, North Carolina, 27101
United States
Oklahoma Eye Surgeons /ID# 252089
Oklahoma City, Oklahoma, 73112
United States
Drs Fine Hoffman & Sims LLC /ID# 235919
Eugene, Oregon, 97401
United States
Scott and Christie and Associates /ID# 252284
Cranberry Township, Pennsylvania, 16066
United States
Advancing Vision Research /ID# 236683
Smyrna, Tennessee, 37167
United States
Keystone Research /ID# 266772
Austin, Texas, 78731
United States
St. George Eye Center /ID# 236200
Saint George, Utah, 84790
United States
Piedmont Eye Center /ID# 246455
Lynchburg, Virginia, 24502
United States
Vistar Eye Center /ID# 234811
Roanoke, Virginia, 24011
United States

Collaborators and Investigators

Sponsor: AbbVie

  • ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-16
Study Completion Date2028-08-30

Study Record Updates

Study Start Date2020-11-16
Study Completion Date2028-08-30

Terms related to this study

Keywords Provided by Researchers

  • Open-angle glaucoma
  • Ocular hypertension

Additional Relevant MeSH Terms

  • Open-angle Glaucoma
  • Ocular Hypertension