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Laser Therapy

Selective Laser Trabeculoplasty for Glaucoma (COAST Trial)

Phase 3

Recruiting

Led By Goundappa K Balasubramani, PhD

Research Sponsored by West Virginia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Each eye with one of the following qualifying diagnoses: High-risk ocular hypertension (OHT), Mild primary open-angle glaucoma, Moderate primary open-angle glaucoma

Be older than 18 years old

Must not have

Any corneal pathology that would preclude accurate assessment of IOP by Goldmann tonometry in either eye

Use of topical IOP-lowering medications for more than 6 cumulative months at any time in the past 5 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12, 24, 36, and 48 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing if a lower-energy version of a common glaucoma treatment is as effective as the standard treatment, and if repeating the lower-energy treatment yearly is better than waiting for the treatment to wear off.

Who is the study for?

This trial is for adults over 18 with high-risk ocular hypertension or mild to moderate primary open-angle glaucoma, who haven't had any previous treatments. Participants should have good overall health and a vision of at least 20/200. Those with recent eye surgery, advanced glaucoma, certain angle closures in the eye, or inability to attend study visits cannot join.

What is being tested?

The study compares two types of SLT therapy for eye conditions: Standard Energy SLT versus Low Energy SLT. It aims to determine if low energy is as effective as standard energy and whether annual low-energy treatments can delay the need for daily medications better than waiting until effects wear off.

What are the potential side effects?

SLT side effects may include mild pain during treatment, temporary increase in intraocular pressure, inflammation inside the eye (iritis), blurry vision shortly after procedure, and potential damage to corneal tissue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a serious form of eye pressure or glaucoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I don't have eye conditions that would affect pressure measurements.

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I have used eye pressure-lowering drops for over 6 months in the past 5 years.

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I can attend all scheduled study visits.

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I have a type of glaucoma that is not primary open-angle glaucoma.

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I have narrow or closed angles in my eye.

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I have had surgery or laser treatment to lower my eye pressure.

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I have advanced glaucoma in at least one eye.

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I have not had eye surgery in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12, 24, 36, and 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12, 24, 36, and 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12, 24, 36, and 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

12-month survival

48-month survival

Secondary study objectives

Incidence of IOP spikes

Long-term mean IOP

Mean IOP

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Second Randomization: Annual Low Energy Repeat SLTExperimental Treatment1 Intervention

At month 12, eligible subjects will be re-randomized to undergo repeat SLT either annually at low energy or as needed at initially assigned energy (from first randomization). The method of SLT delivery is as described in the sections above.

Group II: First Randomization: Low Energy SLTExperimental Treatment1 Intervention

Low energy SLT will consist of 100 treatment spots delivered at 0.4mJ per spot throughout the full 360° treatment, with the exception that energy can be reduced to 0.3mJ if bubbles are seen with 5 consecutive spots and can be increased back to a maximum of 0.4mJ is no bubbles are seen with 5 consecutive spots. Regardless of energy level randomization, energy may be adjusted downward in 0.1mJ increments throughout the procedure in response to factors such as heavy focal pigmentation or patient discomfort.

Group III: Second Randomization: As-Needed Repeat SLT at Initial EnergyActive Control2 Interventions

Group IV: First Randomization: Standard Energy SLTActive Control1 Intervention

Standard SLT will be performed as follows: beginning at 0.8 mJ, energy will be titrated up or down within the first 5-10 spots until champagne bubbles are visualized with every 2nd or 3rd spot. Energy can be titrated throughout the procedure, in response to variations in pigmentation, to ensure the appearance of champagne bubbles with every 2nd or 3rd spot throughout the full 360° treatment. Energy should be increased if no bubbles are seen with 5 consecutive spots and decreased if bubbles are seen with 5 consecutive spots. Regardless of energy level randomization, energy may be adjusted downward in 0.1mJ increments throughout the procedure in response to factors such as heavy focal pigmentation or patient discomfort.

0 / 9Eligibility criteria met