Open-angle GlaucomaPhase 4AGLTNCT03648229
African Glaucoma Laser Trial
A Phase 4 study testing Selective laser trabeculoplasty (SLT), Latanoprost ophthalmic solution and Timolol ophthalmic solution in people with Open-angle Glaucoma, run by West Virginia University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open-angle Glaucoma
- What is being tested?
- Selective laser trabeculoplasty (SLT), Latanoprost ophthalmic solution and Timolol ophthalmic solution
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to 30 Jun 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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
About this study
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.
Read the 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.
- Conditions
- Open-angle Glaucoma
- Being tested
- Selective laser trabeculoplasty (SLT), Latanoprost ophthalmic solution, Timolol ophthalmic solution
- Keywords
- glaucoma, laser, Africa
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective laser trabeculoplasty (SLT)Procedure or surgery
Delivery of laser energy to the trabecular meshwork of the eye with the goal of reducing intraocular pressure
Latanoprost ophthalmic solutionDrug
Prostaglandin analogue topical ophthalmic medication for reduction of intraocular pressure
Timolol ophthalmic solutionDrug
Timolol ophthalmic solution 0.5% for reduction of intraocular pressure
| Study group | Role | What they receive |
|---|---|---|
| SLT | Experimental | The study eye will undergo 360-degree selective laser trabeculoplasty (SLT), followed, if needed, by repeat 360-degree SLT. Receives: Procedure: Selective laser trabeculoplasty (SLT) |
| MED | Active comparator | 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. Receives: Drug: Latanoprost ophthalmic solution; Drug: Timolol ophthalmic solution |
| RX | Active comparator | 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. Receives: Drug: Latanoprost ophthalmic solution; Drug: Timolol ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Month 12
Secondary outcomes (3)
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
Measured: Month 12
Nature and incidence of treatment-emergent adverse events
Nature and frequency of adverse events reported in each treatment arm
Measured: 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
Measured: Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start1 Sep 2019 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2024 (estimated)
Why it stopped: Funding unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open-angle GlaucomaStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, active-controlled parallel-group design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, University of Michigan
- Responsible party
- Principal investigator, Anthony Realini, West Virginia University
- Investigators
- Anthony D Realini, MD, Study chair, West Virginia University Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648229
- Sponsor's protocol ID
- AGLT
- Acronym
- AGLT
- Status last verified
- Jun 2021
- First submitted
- 14 Aug 2018
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: To be determined by NIH Data Sharing Policy
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- African Glaucoma Laser Trial
- ClinicalTrials.gov ID
- NCT03648229
- Acronym / sponsor ID
- AGLT / AGLT
- Conditions
- Open-angle Glaucoma
- Keywords
- glaucoma, laser, Africa
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding unavailable
- Enrolment
- 0 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Collaborators
- University of Pittsburgh, University of Michigan
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective, randomized, active-controlled parallel-group design
| Arm | Type | Receives |
|---|---|---|
| SLT | Experimental | Procedure: Selective laser trabeculoplasty (SLT)The study eye will undergo 360-degree selective laser trabeculoplasty (SLT), followed, if needed, by repeat 360-degree SLT. |
| MED | Active comparator | Drug: Latanoprost ophthalmic solution, Drug: Timolol ophthalmic solutionThe 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. |
| RX | Active comparator | Drug: Latanoprost ophthalmic solution, Drug: Timolol ophthalmic solutionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
- Treatment-naïve: no prior treatment for open-angle glaucoma (including medications, laser, or glaucoma surgery) in both eyes
Key exclusion criteria (15 listed)
- 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)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selective laser trabeculoplasty (SLT)Delivery of laser energy to the trabecular meshwork of the eye with the goal of reducing intraocular pressure | Procedure or surgery | SLT |
| Latanoprost ophthalmic solutionProstaglandin analogue topical ophthalmic medication for reduction of intraocular pressure | Drug | MED, RX |
| Timolol ophthalmic solutionTimolol ophthalmic solution 0.5% for reduction of intraocular pressure | Drug | MED, RX |
Primary outcome
12-month survival using Step 1 of assigned therapy
Time frame: Month 12
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
3 secondary outcomes
12-month survival using Step 1 +/- Step 2 of assigned therapy
Time frame: Month 12
Nature and incidence of treatment-emergent adverse events
Time frame: Month 12
Clinical utility of repeat SLT
Time frame: Month 36
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Individual participant dataSharing planned: No. To be determined by NIH Data Sharing Policy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony D Realini, MD study chair
West Virginia University Eye Institute
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Selective laser trabeculoplasty (SLT), Latanoprost ophthalmic solution and Timolol ophthalmic solution in people with Open-angle Glaucoma, run by West Virginia University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-month survival using Step 1 of assigned therapy (time frame: Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2021; AzTrials last refreshed its copy on 3 Nov 2026.