African Glaucoma Laser Trial

• Status: Withdrawn
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: West Virginia University
• Collaborators: University of Michigan; University of Pittsburgh
• Treatments: Latanoprost; Ophthalmic Solutions; Pharmaceutical Solutions; Timolol

Criteria

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