African Glaucoma Laser Trial

NCT03648229 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: AGLT
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Open-angle Glaucoma

Keywords

glaucoma; laser; Africa

Outcome Measures

Primary Outcomes (1)

• 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

  Month 12

Secondary Outcomes (3)

• 12-month survival using Step 1 +/- Step 2 of assigned therapy

  Month 12

• Nature and incidence of treatment-emergent adverse events

  Month 12

• Clinical utility of repeat SLT

  Month 36

Study Arms (3)

SLT

EXPERIMENTAL

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

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.

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.

Drug: Latanoprost ophthalmic solution; Drug: Timolol ophthalmic solution

Interventions

Selective laser trabeculoplasty (SLT) PROCEDURE

Delivery of laser energy to the trabecular meshwork of the eye with the goal of reducing intraocular pressure

SLT

Latanoprost ophthalmic solution DRUG

Prostaglandin analogue topical ophthalmic medication for reduction of intraocular pressure

MED; RX

Timolol ophthalmic solution DRUG

Timolol ophthalmic solution 0.5% for reduction of intraocular pressure

MED; RX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• West Virginia University: lead
• University of Pittsburgh: collaborator
• University of Michigan: collaborator

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Anthony D Realini, MD

  West Virginia University Eye Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Ophthalmology

Model Details: Prospective, randomized, active-controlled parallel-group design

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 27, 2018
• Study Start: September 1, 2019
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2024
• Last Updated: June 21, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share