A Phase 4 interventional study of Selective laser trabeculoplasty (SLT) and Latanoprost ophthalmic solution in Open-angle Glaucoma, sponsored by West Virginia University. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-21.
Sponsored by West Virginia University · Phase 4, Interventional, and Treatment
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.
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)
MED arm (provided at no cost)
RX arm (Usual Care- dispensed by prescription to be obtained at subjects' expense)
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 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.
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Diagnosed with
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.
Exclusion Criteria:
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)
Contraindications to any of the study interventions
The study eye will undergo 360-degree selective laser trabeculoplasty (SLT), followed, if needed, by repeat 360-degree SLT.
Procedure: Selective laser trabeculoplasty (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.
Drug: Latanoprost ophthalmic solution · Drug: Timolol ophthalmic solution
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.
Drug: Latanoprost ophthalmic solution · Drug: Timolol ophthalmic solution
Delivery of laser energy to the trabecular meshwork of the eye with the goal of reducing intraocular pressure
Prostaglandin analogue topical ophthalmic medication for reduction of intraocular pressure
Timolol ophthalmic solution 0.5% for reduction of intraocular pressure
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
Time frame: Month 12
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
Time frame: Month 12
Nature and incidence of treatment-emergent adverse events
Nature and frequency of adverse events reported in each treatment arm
Time frame: Month 12
Clinical utility of repeat SLT
Mean IOP at each time point following repeat SLT compared to initial SLT; nature and incidence of adverse events
Time frame: Month 36
No study locations are listed for this record.
Plan to share: No — To be determined by NIH Data Sharing Policy
No publications or documents are linked to this record.
This study is withdrawn, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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