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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12, 24, 36, and 48 months
Awards & highlights
COAST 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.Check my eligibility
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.See study design
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.
COAST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a serious form of eye pressure or glaucoma.
COAST Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
12-month survival
48-month medication-free survival
Secondary outcome measures
Incidence of IOP spikes
Long-term mean IOP
Mean IOP
COAST Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Second Randomization: Annual Low Energy Repeat SLTExperimental Treatment1 Intervention
At month 12, subjects remaining medication-free 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
At month 12, subjects remaining medication-free 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 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.
Find a Location
Who is running the clinical trial?
West Virginia UniversityLead Sponsor
176 Previous Clinical Trials
59,588 Total Patients Enrolled
4 Trials studying Glaucoma
164 Patients Enrolled for Glaucoma
University of PittsburghOTHER
1,722 Previous Clinical Trials
16,342,296 Total Patients Enrolled
6 Trials studying Glaucoma
10,505 Patients Enrolled for Glaucoma
Tony Realini, MD, MPHStudy ChairWest Virginia University
1 Previous Clinical Trials
129 Total Patients Enrolled
1 Trials studying Glaucoma
129 Patients Enrolled for Glaucoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have eye conditions that would affect pressure measurements.I have mild glaucoma with specific vision field limits.I have moderate open-angle glaucoma with specific vision field limits.I have used eye pressure-lowering drops for over 6 months in the past 5 years.I can attend all scheduled study visits.I have a type of glaucoma that is not primary open-angle glaucoma.I have narrow or closed angles in my eye.I have had surgery or laser treatment to lower my eye pressure.I am 18 or older and in good health.I have advanced glaucoma in at least one eye.I have high eye pressure over 21 mmHg but no signs of glaucoma damage.I have been diagnosed with a serious form of eye pressure or glaucoma.I have not had eye surgery in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Second Randomization: As-Needed Repeat SLT at Initial Energy
- Group 2: First Randomization: Standard Energy SLT
- Group 3: First Randomization: Low Energy SLT
- Group 4: Second Randomization: Annual Low Energy Repeat SLT
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there numerous hospitals conducting this clinical trial throughout Canada?
"The current study has 18 sites, which are situated in Reading, Cleveland, Laguna Hills and a few other places. If you want to take part in this trial, try to select the site that is closest to your location so that you won't have to travel far."
Answered by AI
What is the study's participant cap?
"Yes. The trial is ongoing and has 18 sites across the country. Currently, they are looking for 640 participants in total."
Answered by AI
Does Low Energy SLT have any serious risks for human patients?
"Low Energy SLT has been studied in Phase 3 trials, which means that while there is evidence of efficacy, multiple rounds of data have also supported its safety. As such, our team rates it as a 3."
Answered by AI
Are people with the relevant medical conditions able to enroll in this trial today?
"Currently, this trial is open and enrolling patients. The information on clinicaltrials.gov indicates that the study was posted on September 22nd, 2021 and updated as recently as July 12th, 2022."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
Doheny Eye Center UCLA
University of California, San Francisco
Other
New York Eye Surgery Associates
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What state do they live in?
Michigan
How many prior treatments have patients received?
0
3+
How responsive is this trial?
Typically responds via
Phone Call
Average response time
- < 2 Days
Most responsive sites:
- Kresge Eye Institute Wayne State University: < 48 hours
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