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African Glaucoma Laser Trial (AGLT)

Primary Purpose

Open-angle Glaucoma

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Selective laser trabeculoplasty (SLT)
Latanoprost ophthalmic solution
Timolol ophthalmic solution
Sponsored by
West Virginia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open-angle Glaucoma focused on measuring glaucoma, laser, Africa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Male or female black African aged 18 years or older

  4. Diagnosed with

    1. early or moderate open-angle glaucoma in one or both eyes (cup-disc ratio (CDR) < 0.9 and (if available) no glaucoma-related visual field loss in the central 10° on automated perimetry; or,
    2. if diagnosed with advanced glaucoma (CDR > 0.9 or glaucoma-related visual field loss within the central 10° on automated perimetry), meet at least one of the following criteria:

    i. Surgery is not available in the region of the study site; or ii. The subject is deemed not to be a candidate for surgery in the investigator's judgment; or iii. Surgery was offered and refused with no knowledge of this study.

  5. Treatment-naïve: no prior treatment for open-angle glaucoma (including medications, laser, or glaucoma surgery) in both eyes
  6. Untreated intraocular pressure >18 mmHg and <32 mmHg in the study eye at both baseline visits
  7. Best-corrected visual acuity no worse than 20/400 in the study eye measured using Snellen's chart
  8. Open iridocorneal angle (Shaffer Grade 3 or 4) with no more than 3 clock hours of peripheral anterior synechiae in both eyes
  9. No contraindications to any of the study interventions
  10. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.

Exclusion Criteria:

  1. Any glaucoma diagnosis other than open-angle glaucoma

  2. Advanced stage glaucoma, defined as CDR > 0.9 or visual field loss within the central 10° on automated perimetry attributable to glaucoma (in the investigator's judgment)

    • The rationale for excluding subjects with advanced glaucoma is that these subjects would typically undergo surgery rather than laser or medical treatment. However, subjects with advanced stage glaucoma can be enrolled if any of the following three conditions are met:
    • Surgery is not available in the region of the study site; or
    • The subject is deemed not to be a candidate for surgery in the investigator's judgment; or
    • Surgery was offered and refused with no knowledge of this study In these cases, the subject would not undergo surgery regardless of participation in the study, and therefore should not be prevented from participation on this basis alone.
  3. Currently or previously under treatment for glaucoma using medications, laser therapy or surgical interventions
  4. Any corneal pathology that would preclude accurate assessment of IOP by rebound tonometry
  5. Any non-glaucoma intraocular surgical procedure within the past 6 months

  6. Contraindications to any of the study interventions

    • For SLT: no known absolute contraindications
    • For latanoprost: known hypersensitivity to any product ingredients
    • For timolol: bronchial asthma or history of such; severe chronic obstructive pulmonary disease; sinus bradycardia (<55 beats per minute); second or third degree atrioventricular block; overt cardiac failure; cardiogenic shock; hypersensitivity to any product ingredients
  7. Pregnancy or lactation
  8. Inability to attend all scheduled study visits

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    SLT

    MED

    RX

    Arm Description

    The study eye will undergo 360-degree selective laser trabeculoplasty (SLT), followed, if needed, by repeat 360-degree SLT.

    The study eye will receive latanoprost ophthalmic solution 0.005% once daily, followed, if needed, by adjunctive timolol ophthalmic solution 0.5% twice daily. Medications will be provided at no cost to the subject.

    The study eye will receive latanoprost ophthalmic solution 0.005% once daily, followed, if needed, by adjunctive timolol ophthalmic solution 0.5% twice daily. Medications will be provided by prescription to be obtained at the subject's expense. This represents usual care for glaucoma in Africa and other regions of the world.

    Outcomes

    Primary Outcome Measures

    12-month survival using Step 1 of assigned therapy
    The proportion of eyes in each treatment group that achieve and maintain target IOP (minimum 20% reduction from baseline and IOP < 22 mmHg) through Month 12 using only Step 1 of therapy

    Secondary Outcome Measures

    12-month survival using Step 1 +/- Step 2 of assigned therapy
    The proportion of eyes in each treatment group that achieve and maintain target IOP (minimum 20% reduction from baseline and IOP < 22 mmHg) through Month 12 using Step 1 +/- Step 2 of therapy
    Nature and incidence of treatment-emergent adverse events
    Nature and frequency of adverse events reported in each treatment arm
    Clinical utility of repeat SLT
    Mean IOP at each time point following repeat SLT compared to initial SLT; nature and incidence of adverse events

    Full Information

    First Posted
    August 14, 2018
    Last Updated
    June 17, 2021
    Sponsor
    West Virginia University
    Collaborators
    University of Pittsburgh, University of Michigan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03648229
    Brief Title
    African Glaucoma Laser Trial
    Acronym
    AGLT
    Official Title
    African Glaucoma Laser Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Funding unavailable
    Study Start Date
    September 1, 2019 (Anticipated)
    Primary Completion Date
    June 30, 2022 (Anticipated)
    Study Completion Date
    June 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    West Virginia University
    Collaborators
    University of Pittsburgh, University of Michigan

    4. Oversight

    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.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The AGLT is a prospective, multicenter, randomized study in which adult black Africans with treatment-naive open-angle glaucoma are assigned to therapy with selective laser trabeculoplasty (SLT), medications provided at no cost (MED), or medications provided by prescription for subjects to obtain at their own expense as per usual care (RX). The overall goal of the AGLT is to determine the best treatment strategy for newly-diagnosed open-angle glaucoma in Africa.
    Detailed Description
    This study is designed to test the hypothesis that the efficacy of SLT is non-inferior to medical therapy and the effectiveness of SLT is superior to medical therapy for glaucoma. This is a prospective, multicenter, active-controlled, parallel-group randomized trial. One eye per subject is included in this study and is randomized 1:1:1 to one of three treatment arms: SLT arm (provided at no cost) Step 1: Initial 360 degree SLT Step 2: Repeat 360 degree SLT MED arm (provided at no cost) Step 1: Latanoprost 0.005% once daily Step 2: Adjunctive timolol 0.5% twice daily RX arm (Usual Care- dispensed by prescription to be obtained at subjects' expense) Step 1: Prescription for latanoprost 0.005% once daily Step 2: Prescription for adjunctive timolol 0.5% twice daily Screening and baseline data are collected over two initial study visits. Baseline intraocular pressure (IOP) is determined and target IOP is calculated as a 20% reduction from baseline IOP and IOP < 22 mmHg. Following the initiation of step one of assigned therapy, subjects in the SLT arm will attend a Week 1 safety visit. All subjects will be seen at Month 1 for the first efficacy evaluation, then again at Month 3 and then every 3 months thereafter through 36 months of follow-up. Eyes with IOP above target IOP at two consecutive visits during the first 12 months will be deemed to have failed current therapy and are advanced to step 2 of assigned therapy: In the SLT arm, if step 1 (initial SLT) does not achieve or maintain target IOP, step 2 (repeat SLT) should be performed. One repeat SLT (two total) are allowed in the first 12 months following initial SLT; thereafter, SLT can be repeated as often as every 6 months. In the MED and RX arms, if step 1 does not achieve target IOP, latanoprost therapy should be continued and timolol added. In all arms, if subjects fail step 2 of assigned therapy before Month 12, the subject is discontinued from study therapy, treated as deemed appropriate by site investigators, and continues to attend scheduled study visits and undergo safety-related study assessments. At Month 12, subjects in the SLT arm who have failed step 2 of therapy (repeat SLT) by Month 12 exit the study (as failure of 2 SLT treatments within 12 months indicates the subject is a poor candidate for further SLT). At Month 12, subjects in the MED and RX arms who are still active in the study (either still a success with Step 1 or 2 of assigned therapy; or failed step 2 but continue to attend study visits for safety assessment) will cross over to the SLT arm, discontinue medications, and undergo initial SLT. These subjects will attend a safety visit 1 week later and the first efficacy visit 1 month later. One repeat SLT (two total) is allowed in the first 12 months following initial SLT for those crossing over from the MED and RX arms; thereafter, SLT can be repeated as often as every 6 months. The primary outcome measure is intraocular pressure, which will be assessed by study personnel masked to treatment assignment during the first 12 months and to all prior IOP measurements at every visit.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Open-angle Glaucoma
    Keywords
    glaucoma, laser, Africa

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    Prospective, randomized, active-controlled parallel-group design
    Masking
    Outcomes Assessor
    Masking Description
    Study personnel assessing IOP will be masked to treatment assignment during the first 12-month period and to all prior IOP measurements at every visit. IOP will be obtained using the iCare tonometer which provides an objective, digital reading.
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SLT
    Arm Type
    Experimental
    Arm Description
    The study eye will undergo 360-degree selective laser trabeculoplasty (SLT), followed, if needed, by repeat 360-degree SLT.
    Arm Title
    MED
    Arm Type
    Active Comparator
    Arm Description
    The study eye will receive latanoprost ophthalmic solution 0.005% once daily, followed, if needed, by adjunctive timolol ophthalmic solution 0.5% twice daily. Medications will be provided at no cost to the subject.
    Arm Title
    RX
    Arm Type
    Active Comparator
    Arm Description
    The study eye will receive latanoprost ophthalmic solution 0.005% once daily, followed, if needed, by adjunctive timolol ophthalmic solution 0.5% twice daily. Medications will be provided by prescription to be obtained at the subject's expense. This represents usual care for glaucoma in Africa and other regions of the world.
    Intervention Type
    Procedure
    Intervention Name(s)
    Selective laser trabeculoplasty (SLT)
    Intervention Description
    Delivery of laser energy to the trabecular meshwork of the eye with the goal of reducing intraocular pressure
    Intervention Type
    Drug
    Intervention Name(s)
    Latanoprost ophthalmic solution
    Intervention Description
    Prostaglandin analogue topical ophthalmic medication for reduction of intraocular pressure
    Intervention Type
    Drug
    Intervention Name(s)
    Timolol ophthalmic solution
    Intervention Description
    Timolol ophthalmic solution 0.5% for reduction of intraocular pressure
    Primary Outcome Measure Information:
    Title
    12-month survival using Step 1 of assigned therapy
    Description
    The proportion of eyes in each treatment group that achieve and maintain target IOP (minimum 20% reduction from baseline and IOP < 22 mmHg) through Month 12 using only Step 1 of therapy
    Time Frame
    Month 12
    Secondary Outcome Measure Information:
    Title
    12-month survival using Step 1 +/- Step 2 of assigned therapy
    Description
    The proportion of eyes in each treatment group that achieve and maintain target IOP (minimum 20% reduction from baseline and IOP < 22 mmHg) through Month 12 using Step 1 +/- Step 2 of therapy
    Time Frame
    Month 12
    Title
    Nature and incidence of treatment-emergent adverse events
    Description
    Nature and frequency of adverse events reported in each treatment arm
    Time Frame
    Month 12
    Title
    Clinical utility of repeat SLT
    Description
    Mean IOP at each time point following repeat SLT compared to initial SLT; nature and incidence of adverse events
    Time Frame
    Month 36

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Male or female black African aged 18 years or older Diagnosed with early or moderate open-angle glaucoma in one or both eyes (cup-disc ratio (CDR) < 0.9 and (if available) no glaucoma-related visual field loss in the central 10° on automated perimetry; or, if diagnosed with advanced glaucoma (CDR > 0.9 or glaucoma-related visual field loss within the central 10° on automated perimetry), meet at least one of the following criteria: i. Surgery is not available in the region of the study site; or ii. The subject is deemed not to be a candidate for surgery in the investigator's judgment; or iii. Surgery was offered and refused with no knowledge of this study. Treatment-naïve: no prior treatment for open-angle glaucoma (including medications, laser, or glaucoma surgery) in both eyes Untreated intraocular pressure >18 mmHg and <32 mmHg in the study eye at both baseline visits Best-corrected visual acuity no worse than 20/400 in the study eye measured using Snellen's chart Open iridocorneal angle (Shaffer Grade 3 or 4) with no more than 3 clock hours of peripheral anterior synechiae in both eyes No contraindications to any of the study interventions For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation. Exclusion Criteria: Any glaucoma diagnosis other than open-angle glaucoma Advanced stage glaucoma, defined as CDR > 0.9 or visual field loss within the central 10° on automated perimetry attributable to glaucoma (in the investigator's judgment) The rationale for excluding subjects with advanced glaucoma is that these subjects would typically undergo surgery rather than laser or medical treatment. However, subjects with advanced stage glaucoma can be enrolled if any of the following three conditions are met: Surgery is not available in the region of the study site; or The subject is deemed not to be a candidate for surgery in the investigator's judgment; or Surgery was offered and refused with no knowledge of this study In these cases, the subject would not undergo surgery regardless of participation in the study, and therefore should not be prevented from participation on this basis alone. Currently or previously under treatment for glaucoma using medications, laser therapy or surgical interventions Any corneal pathology that would preclude accurate assessment of IOP by rebound tonometry Any non-glaucoma intraocular surgical procedure within the past 6 months Contraindications to any of the study interventions For SLT: no known absolute contraindications For latanoprost: known hypersensitivity to any product ingredients For timolol: bronchial asthma or history of such; severe chronic obstructive pulmonary disease; sinus bradycardia (<55 beats per minute); second or third degree atrioventricular block; overt cardiac failure; cardiogenic shock; hypersensitivity to any product ingredients Pregnancy or lactation Inability to attend all scheduled study visits
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anthony D Realini, MD
    Organizational Affiliation
    West Virginia University Eye Institute
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    To be determined by NIH Data Sharing Policy

    Learn more about this trial

    African Glaucoma Laser Trial

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