Study of AGN-190584 Eye Drops to Assess Safety and Efficacy in Participants Aged 40-80 Years With Pseudophakic Presbyopia (ARIES)

A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of AGN-190584 in Subjects With Pseudophakic Presbyopia

Presbyopia is a condition in which the eye exhibits a diminished ability to focus on near objects with increasing age. This study will assess the safety and exploratory efficacy of AGN-190584 is in treating participants with pseudophakic presbyopia.

AGN-190584 is approved (in the United States) for use in adults with presbyopia (including those who are pseudophakic) and this study is being conducted to better understand the safety and efficacy in the pseudophakic presbyopia population. This study is double-masked meaning that neither the participants nor the study doctors will know who will be given AGN-190584 and who will be given vehicle (does not contain treatment drug). Study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to vehicle. Approximately 150 participants aged 40-80 years with pseudophakic presbyopia will be enrolled in approximately 30 sites in the US.

Participants will receive eye drops of AGN-190584 or vehicle once daily in the morning in each eye for 14 days.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study. The effect of the treatment will be evaluated by medical assessments, checking for side effects and completing questionnaires.

Study Overview

• Status: Withdrawn
• Conditions: Presbyopia
• Intervention / Treatment: Drug: AGN-190584; Drug: Vehicle

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Dothan, Alabama, United States, 36301
      • Trinity Research Group /ID# 243541
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Arizona Eye Center /ID# 243897
  • California
    • Glendale, California, United States, 91204-2500
      • Global Research Management /ID# 243544
    • Inglewood, California, United States, 90301
      • United Medical Research Institute /ID# 243531
    • Newport Beach, California, United States, 92663-3600
      • Salvay Vision /ID# 243828
    • Newport Beach, California, United States, 92663-3637
      • The Eye Research Foundation /ID# 243524
    • Sacramento, California, United States, 95815
      • Sacramento Eye Consultants /ID# 243538
  • Florida
    • Crystal River, Florida, United States, 34429
      • Nature Coast Clinical Research - Crystal River /ID# 243519
    • Delray Beach, Florida, United States, 33484
      • Segal Drug Trials, Inc /ID# 243521
    • Fort Myers, Florida, United States, 33901
      • Eye Associates of Fort Meyers /ID# 243545
    • Jacksonville, Florida, United States, 32204
      • Levenson Eye Associates Inc. /ID# 243532
  • Georgia
    • Atlanta, Georgia, United States, 30322-1013
      • Emory University /ID# 243534
    • Morrow, Georgia, United States, 30260-4180
      • Clayton Eye Clinical Research, LLC /ID# 243530
    • Roswell, Georgia, United States, 30076
      • Coastal Research Associates /ID# 243525
  • Kansas
    • Pittsburg, Kansas, United States, 66762-2620
      • Kannarr Eye Care /ID# 243542
  • Kentucky
    • Edgewood, Kentucky, United States, 41017-3415
      • Cincinnati Eye Institute- Edgewood /ID# 243810
    • Louisville, Kentucky, United States, 40206-1738
      • The Eye Care Institute /ID# 243588
  • Michigan
    • Fraser, Michigan, United States, 48026
      • Fraser Eye Center /ID# 244038
  • Missouri
    • Kansas City, Missouri, United States, 64034
      • Silverstein Eye Centers /ID# 243546
  • New Jersey
    • Dover, New Jersey, United States, 07801-1629
      • Eye Associates of North Jersey /ID# 243913
    • South Orange, New Jersey, United States, 07079-1855
      • Northern New Jersey Eye Institute PA /ID# 243522
  • New York
    • Rochester, New York, United States, 14618-2616
      • Rochester Ophthalmological Group PC /ID# 243539
  • Ohio
    • Powell, Ohio, United States, 43065
      • EyeCare Professionals Inc /ID# 243938
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Scott and Christie and Associates /ID# 243548
  • Tennessee
    • Maryville, Tennessee, United States, 37805
      • University Eye Surgeons /ID# 243926
    • Smyrna, Tennessee, United States, 37167
      • Advancing Vision Research /ID# 243529
  • Texas
    • Dallas, Texas, United States, 75243
      • Key-Whitman Eye Center /ID# 243928
    • San Antonio, Texas, United States, 78229
      • Eye associates /ID# 243526
    • San Antonio, Texas, United States, 78229
      • Parkhurst Nuvision /ID# 244041
  • Utah
    • Draper, Utah, United States, 84020-7133
      • Hoopes, Durrie, Rivera Research /ID# 243535
    • Ogden, Utah, United States, 84403-2200
      • Country Hills Eye Center /ID# 243520
    • Saint George, Utah, United States, 84790
      • Southern Utah Medical Research /ID# 243931

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• History of bilateral pseudophakia with monofocal intraocular lenses corrected for distance (noncomplicated cataract surgery), with identifiable intraocular lens type/brand, at least 3 months after surgery (prior to baseline), and be in stable condition.
• If a participant has had neodymium-doped yttrium aluminum garnet (Nd:YAG) laser capsulotomy, it needs to be done bilaterally at least 1 month prior to baseline.
• Subjective complaints of poor near vision that impacts activities of daily living, as defined by at least a moderate impact (score >= 3) on at least 1 question on 25-Item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) Questions 5 to 7 in the main questionnaire or Near Vision Subscale, Questions A3 to A5 in the Appendix of Optional Additional Questions at the screening visit.
• Best distance correction at screening in the range of spherical -1.50 D to +1.00 D inclusively and cylinder <= ±2.00 D with photopic high contrast binocular corrected distance visual acuity (CDVA) of 20/25 or better at the screening and baseline visits.
• Mesopic, high contrast binocular distance-corrected near visual acuity (DCNVA) no better than 20/40 (J3) at screening and baseline visits.

Exclusion Criteria:

- Presence of any ocular condition that, in the opinion of the investigator, could affect the safety of the participant or interpretation of efficacy parameters (e.g., uveitis, acute iritis, retinal detachment or retinal tear).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AGN-190584; Participants will receive one drop of AGN-190584 instilled in each eye once daily for 14 days.	Drug: AGN-190584; Eye drops
Placebo Comparator: Vehicle; Participants will receive one drop of vehicle instilled in each eye once daily for 14 days.	Drug: Vehicle; Eye drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Experiencing Adverse Events (AEs)	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.	Up to approximately 14 days

Collaborators and Investigators

• Sponsor: Allergan

Study record dates

Study Major Dates

• Study Start (Anticipated): June 9, 2022
• Primary Completion (Anticipated): April 4, 2023
• Study Completion (Anticipated): April 4, 2023

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Actual): June 29, 2022
• Last Update Submitted That Met QC Criteria: June 24, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Presbyopia; ARIES; AGN-190584; Pseudophakic Presbyopia; Pilocarpine HCl
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: M21-194

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No