Comparison of Bimatoprost Sustained Release (SR) to Selective Laser Trabeculoplasty (SLT) in Adults With Open-Angle Glaucoma or Ocular Hypertension
NCT ID: NCT02507687
Last Updated: 2024-05-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
240 participants
INTERVENTIONAL
2015-08-27
2023-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Stage 1: SLT (Primary Eye) / Bimatoprost SR 15 µg (Contralateral Eye)
Participants enrolled prior to implementation of Protocol Amendment 3 receive the following treatment in each eye:
Assigned Primary Eye: Selective laser trabeculoplasty (SLT) administered on Day 1 followed by up to three sham bimatoprost SR administrations.
Contralateral Eye: Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 µg administrations.
Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reach Week 32 prior to implementation of Protocol Amendment 3 only).
Bimatoprost SR
Bimatoprost SR is a biodegradable, sustained-release, preservative-free bimatoprost implant, preloaded in an applicator for administration. The Bimatoprost SR implant is injected into the anterior chamber via the corneal limbus using the prefilled applicator.
Sham Bimatoprost SR
Sham bimatoprost SR performed using the same procedure as for Bimatoprost SR using an needleless applicator that touches the eye at the area of insertion but does not deliver an implant into the anterior chamber.
Selective Laser Trabeculoplasty
SLT is a laser procedure that targets the melanin, or pigment, in specific cells of the eye.
An ophthalmologist performed 360 degrees of SLT using a standardized method.
Sham Selective Laser Trabeculoplasty
Sham SLT is performed on the contralateral eye using the same method as for SLT, with the exception that the laser is not switched to the active state.
Stage 1: Bimatoprost SR 15 µg (Primary Eye) / SLT (Contralateral Eye)
Participants enrolled prior to implementation of Protocol Amendment 3 receive the following treatment in each eye:
Assigned Primary Eye: Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 µg administrations.
Contralateral Eye: SLT administered on Day 1 followed by up to three sham bimatoprost SR administrations.
Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reach Week 32 prior to implementation of Protocol Amendment 3 only).
Bimatoprost SR
Bimatoprost SR is a biodegradable, sustained-release, preservative-free bimatoprost implant, preloaded in an applicator for administration. The Bimatoprost SR implant is injected into the anterior chamber via the corneal limbus using the prefilled applicator.
Sham Bimatoprost SR
Sham bimatoprost SR performed using the same procedure as for Bimatoprost SR using an needleless applicator that touches the eye at the area of insertion but does not deliver an implant into the anterior chamber.
Selective Laser Trabeculoplasty
SLT is a laser procedure that targets the melanin, or pigment, in specific cells of the eye.
An ophthalmologist performed 360 degrees of SLT using a standardized method.
Sham Selective Laser Trabeculoplasty
Sham SLT is performed on the contralateral eye using the same method as for SLT, with the exception that the laser is not switched to the active state.
Stage 2: SLT (Primary Eye) / Bimatoprost SR 10 µg (Contralateral Eye)
Participants enrolled after implementation of Protocol Amendment 3 receive the following treatment in each eye:
Assigned Primary Eye: SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations.
Contralateral Eye: Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 µg administrations.
Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could occur after Week 16 and prior to Month 12 based on when retreatment criteria are met.
Bimatoprost SR
Bimatoprost SR is a biodegradable, sustained-release, preservative-free bimatoprost implant, preloaded in an applicator for administration. The Bimatoprost SR implant is injected into the anterior chamber via the corneal limbus using the prefilled applicator.
Sham Bimatoprost SR
Sham bimatoprost SR performed using the same procedure as for Bimatoprost SR using an needleless applicator that touches the eye at the area of insertion but does not deliver an implant into the anterior chamber.
Selective Laser Trabeculoplasty
SLT is a laser procedure that targets the melanin, or pigment, in specific cells of the eye.
An ophthalmologist performed 360 degrees of SLT using a standardized method.
Sham Selective Laser Trabeculoplasty
Sham SLT is performed on the contralateral eye using the same method as for SLT, with the exception that the laser is not switched to the active state.
Stage 2: Bimatoprost SR 10 µg (Primary Eye) / SLT (Contralateral Eye)
Participants enrolled after implementation of Protocol Amendment 3 receive the following treatment in each eye:
Assigned Primary Eye: Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 µg administrations.
Contralateral Eye: SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations.
Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could occur after Week 16 and prior to Month 12 based on when retreatment criteria were met.
Bimatoprost SR
Bimatoprost SR is a biodegradable, sustained-release, preservative-free bimatoprost implant, preloaded in an applicator for administration. The Bimatoprost SR implant is injected into the anterior chamber via the corneal limbus using the prefilled applicator.
Sham Bimatoprost SR
Sham bimatoprost SR performed using the same procedure as for Bimatoprost SR using an needleless applicator that touches the eye at the area of insertion but does not deliver an implant into the anterior chamber.
Selective Laser Trabeculoplasty
SLT is a laser procedure that targets the melanin, or pigment, in specific cells of the eye.
An ophthalmologist performed 360 degrees of SLT using a standardized method.
Sham Selective Laser Trabeculoplasty
Sham SLT is performed on the contralateral eye using the same method as for SLT, with the exception that the laser is not switched to the active state.
Interventions
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Bimatoprost SR
Bimatoprost SR is a biodegradable, sustained-release, preservative-free bimatoprost implant, preloaded in an applicator for administration. The Bimatoprost SR implant is injected into the anterior chamber via the corneal limbus using the prefilled applicator.
Sham Bimatoprost SR
Sham bimatoprost SR performed using the same procedure as for Bimatoprost SR using an needleless applicator that touches the eye at the area of insertion but does not deliver an implant into the anterior chamber.
Selective Laser Trabeculoplasty
SLT is a laser procedure that targets the melanin, or pigment, in specific cells of the eye.
An ophthalmologist performed 360 degrees of SLT using a standardized method.
Sham Selective Laser Trabeculoplasty
Sham SLT is performed on the contralateral eye using the same method as for SLT, with the exception that the laser is not switched to the active state.
Eligibility Criteria
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Inclusion Criteria
* In the investigator's opinion, patient's IOP is not adequately managed with topical medication for reasons other than medication efficacy (eg, due to intolerance or nonadherence).
* In the investigator's opinion, both eyes can be treated adequately with topical prostamide, prostaglandin, or prostaglandin analog eye drops as the sole therapy if medication was taken as directed, or with SLT monotherapy.
Exclusion Criteria
* History or evidence of complicated cataract surgery: eg, surgery resulting in complicated lens placement (such as anterior chamber intraocular lens implant \[IOL\], sulcus IOL, aphakia, etc) or intraoperative complications (such as a posterior capsular tear \[with or without vitreous loss\], substantial iris trauma, etc) or history of phakic IOL insertion for refractive error correction
* Intraocular surgery (including cataract surgery) and/or any ocular laser surgery within the 6 months prior to treatment
* Previous use of commercially available Bimatoprost SR; concurrent enrollment in another Allergan Bimatoprost SR study; or previous enrollment in which an implant was received.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Trinity Research Group /ID# 234598
Dothan, Alabama, United States
Arizona Advanced Eye Research Institute /ID# 234947
Glendale, Arizona, United States
Arizona Glaucoma Specialists /ID# 235066
Phoenix, Arizona, United States
M&M Eye Institute /ID# 235391
Prescott, Arizona, United States
Walman Eye Center /ID# 236054
Sun City, Arizona, United States
California Center for Clin Res /ID# 237412
Arcadia, California, United States
Orange County Ophthalmology /ID# 235995
Garden Grove, California, United States
Speciality Eye Care Medical Group /ID# 236001
Glendale, California, United States
Lugene Eye Institute /ID# 237042
Glendale, California, United States
Lakeside Vision Center /ID# 234971
Irvine, California, United States
California Eye Specialists Medical Group Inc. /ID# 235999
Pasadena, California, United States
North Bay Eye Associates Inc. /ID# 235429
Petaluma, California, United States
Pacific Eye Associates /ID# 235326
San Francisco, California, United States
Wolstan & Goldberg Eye Associates /ID# 235166
Torrance, California, United States
Segal Drug Trials Inc. /ID# 235169
Delray Beach, Florida, United States
Eye Associates of South West Florida /ID# 235424
Fort Myers, Florida, United States
Levenson Eye Associates Inc. /ID# 235021
Jacksonville, Florida, United States
University of Florida /ID# 236876
Jacksonville, Florida, United States
Ocala Eye PA /ID# 235431
Ocala, Florida, United States
Dr. Andrew Gardner Logan, FL /ID# 236946
Tamarac, Florida, United States
University of South Florida /ID# 237737
Tampa, Florida, United States
Clayton Eye Clinical Research, LLC /ID# 236678
Morrow, Georgia, United States
University of Illinois at Chicago Illinois Eye and Ear Infirmary /ID# 234875
Chicago, Illinois, United States
Sabates Eye Centers /ID# 234868
Leawood, Kansas, United States
Cincinnati Eye Institute- Edgewood /ID# 236714
Edgewood, Kentucky, United States
The Eye Care Institute /ID# 236690
Louisville, Kentucky, United States
Advanced Glaucoma Specialists /ID# 234799
Reading, Massachusetts, United States
Fraser Eye Center /ID# 235791
Fraser, Michigan, United States
Midwest Vision Research Foundation at Pepose Vision Institute /ID# 235879
Chesterfield, Missouri, United States
Northern New Jersey Eye Institute PA /ID# 234944
South Orange, New Jersey, United States
Eye Associates of New Mexico /ID# 235115
Albuquerque, New Mexico, United States
Albemarle Clinical Trials LLC /ID# 235144
Elizabeth City, North Carolina, United States
Duplicate_Cornerstone Eye Care /ID# 235047
High Point, North Carolina, United States
Bagan Strinden Vision /ID# 234898
Fargo, North Dakota, United States
Oklahoma Eye Surgeons /ID# 235848
Oklahoma City, Oklahoma, United States
Scott and Christie and Associates /ID# 234594
Cranberry Township, Pennsylvania, United States
Eye Care Specialists /ID# 235129
Kingston, Pennsylvania, United States
Family Eye Group P.C. /ID# 236114
Lancaster, Pennsylvania, United States
Wills Eye Hospital /ID# 236487
Philadelphia, Pennsylvania, United States
Carolinas Centers for Sight,PC /ID# 237017
Florence, South Carolina, United States
Chattanooga Eye Institute /ID# 235250
Chattanooga, Tennessee, United States
ATX Clinical Trials Inc. dba Keystone Research /ID# 235869
Austin, Texas, United States
Cross Eye Center /ID# 236116
Bellaire, Texas, United States
Houston Eye Associates /ID# 237883
Houston, Texas, United States
Baylor College of Medicine - Baylor Medical Center /ID# 237148
Houston, Texas, United States
San Antonio Eye Center /ID# 235632
San Antonio, Texas, United States
Eye associates /ID# 236501
San Antonio, Texas, United States
Medical Center Ophthalmology Associates /ID# 235016
San Antonio, Texas, United States
Emerson Clinical Research Institute /ID# 235977
Falls Church, Virginia, United States
Piedmont Eye Center /ID# 234533
Lynchburg, Virginia, United States
West Virginia University Eye Institute /ID# 235174
Morgantown, West Virginia, United States
Queensland Eye Institute /ID# 236074
South Brisbane, Queensland, Australia
Eye Surgery Associates /ID# 235872
East Melbourne, Victoria, Australia
Melbourne Eye Specialists /ID# 234614
Fitzroy, Victoria, Australia
Waverley Eye Clinic /ID# 234997
Glen Waverley, Victoria, Australia
The Lions Eye Institute /ID# 236832
Nedlands, Western Australia, Australia
Essendon Eye Clinic /ID# 235433
Essendon, , Australia
Geelong Eye Clinic /ID# 236118
Geelong, , Australia
Vision Eye Institute /ID# 236003
Melbourne, , Australia
Ophthalmology Clinic Bellevue /ID# 234631
Montreal, Quebec, Canada
Rigshospitalet Glostrup /ID# 237709
Glostrup Municipality, Capital Region, Denmark
Chu Angers /Id# 237805
Angers, , France
Polyclinique de la Baie /ID# 235842
Avranches, , France
CHU Bordeaux - Hopital Pellegrin /ID# 237705
Bordeaux, , France
Clinique Honore Cave - Pharmacie /ID# 235925
Montauban, , France
CHU de Nice - Hospital Pasteur 2 /ID# 235844
Nice, , France
CHU Strasbourg - Hopital Civil /ID# 237837
Strasbourg, , France
Chu Toulouse Purpan - Hopital Pierre Paul Riquet /ID# 235841
Toulouse, , France
Internationale Innovative Ophthalmochirurgie /ID# 235263
Düsseldorf, North Rhine-Westphalia, Germany
Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 235966
Berlin, , Germany
Universitaetsklinikum Magdeburg /ID# 237284
Magdeburg, , Germany
Tel Aviv Sourasky Medical Center /ID# 237211
Tel Aviv, Tel Aviv, Israel
Rambam Health Care Campus /ID# 237741
Haifa, , Israel
The Lady Davis Carmel Medical Center /ID# 236757
Haifa, , Israel
Galilee Medical Center /ID# 235742
Nahariya, , Israel
Rabin Medical Center /ID# 237698
Petah Tikva, , Israel
Auckland Eye Hospital /ID# 235253
Remuera, Auckland, New Zealand
Southern Eye Specialists /ID# 236081
Christchurch, Canterbury, New Zealand
Capital Eye Specialists /ID# 236111
Wellington, , New Zealand
Asian Eye Institute /ID# 235092
Makati City, , Philippines
Peregrine Eye and Laser Institute /ID# 236220
Makati City, , Philippines
American Eye Center /ID# 235320
Makati City, , Philippines
Cardinal Santos Medical Center /ID# 235325
San Juan City, , Philippines
Centrum Diagnostyki i Mikrochirurgii Oka - LENS dr n. med. Slawomir Zalewski /ID# 235929
Olsztyn, , Poland
Clinical ophthalmology hospital n.a. V.P. Vihodtsev. /ID# 236041
Omsk, , Russia
Samara State Medical University /ID# 236997
Samara, , Russia
University Hospital of Derby and Burton NHS Foundation Trust /ID# 237129
Derby, Derbyshire, United Kingdom
Queen Mary's Hospital /ID# 234899
Greater London, Kent, United Kingdom
Guys and St Thomas NHS Foundation Trust /ID# 236806
London, London, City of, United Kingdom
Epsom & St Helier University Hospital NHS Trust /ID# 236902
Carshalton, Surrey, United Kingdom
Cambridge University Hospitals NHS Foundation Trust /ID# 238315
Cambridge, , United Kingdom
NHS Lothian /ID# 237450
Edinburgh, , United Kingdom
Moorfields Eye Hospital NHS Foundation Trust /ID# 237708
London, , United Kingdom
Imperial College Healthcare NHS Trust /ID# 234777
London, , United Kingdom
Manchester University NHS Foundation Trust /ID# 237318
Manchester, , United Kingdom
Countries
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References
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Kolko M, Tatham AJ, Lim KS, Wells AP, Shiu M, Uy HS, Sarkisian SR Jr, Ho Q, Jiao J, Kim K, Goodkin ML, Bejanian M, Robinson MR, Paauw JD; ATHENA STUDY GROUP. Phase 3, Randomized, Comparison Study of Intracameral Bimatoprost Implant 10 microg and Selective Laser Trabeculoplasty. Am J Ophthalmol. 2025 Apr;272:19-37. doi: 10.1016/j.ajo.2024.12.026. Epub 2025 Jan 10.
Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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2015-002131-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
192024-093
Identifier Type: -
Identifier Source: org_study_id
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