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Vascular Endothelial Growth Factor (VEGF) Inhibitor
OPT-302 + Aflibercept for Age-Related Macular Degeneration (COAST Trial)
Phase 3
Waitlist Available
Research Sponsored by Opthea Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Active subfoveal CNV lesion or juxtafoveal CNV lesion with foveal involvement that is secondary to AMD in the Study Eye.
Clinically significant ocular disorders (other than neovascular AMD), which may interfere with assessment of BCVA, assessment of safety, or fundus imaging.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 52
Awards & highlights
COAST Trial Summary
This trial will compare a new treatment to a sham (fake) treatment in order to see if the new treatment is effective. The primary efficacy will be determined at Week 52, meaning that's how long the trial will last.
Who is the study for?
This trial is for individuals with neovascular Age-related Macular Degeneration (nAMD) who have a specific level of vision acuity, measured by the ETDRS BCVA score between 60 and 25. Participants can have had previous treatments for nAMD but must not have other significant eye disorders or any conditions that could affect study participation.Check my eligibility
What is being tested?
The study is testing a new treatment called OPT-302 in combination with Aflibercept against a sham procedure over two years. The main goal is to see how well it works after one year. Patients are randomly assigned to either get the real treatments or a pretend one without knowing which they're getting.See study design
What are the potential side effects?
Potential side effects were not provided in the information given, but generally, treatments like OPT-302 and Aflibercept may cause eye irritation, discomfort at injection site, changes in vision, increased eye pressure, or inflammation.
COAST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My eye condition is due to AMD and affects the center of my vision.
Select...
I do not have serious eye problems that could affect vision tests or safety assessments.
Select...
I have received treatment for wet age-related macular degeneration.
Select...
I'm sorry, but "Main" is not a specific clinical trial exclusion criterion. Could you please provide me with more information or context?
COAST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean change in Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters
Secondary outcome measures
Change in choroidal neovascularisation (CNV) area by fluorescein angiography (FA)
Proportion of participants gaining 10 or more ETDRS BCVA letters
Proportion of participants gaining 15 or more ETDRS BCVA letters
+1 moreSide effects data
From 2020 Phase 4 trial • 26 Patients • NCT030222924%
Retinal detachment
4%
Myelodysplastic syndrome
4%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
IAI Treatment
COAST Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: 2.0 mg aflibercept with Standard Dosing 2.0 mg OPT-302Experimental Treatment2 Interventions
2.0 mg aflibercept intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals.
2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals.
Group II: 2.0 mg aflibercept with Extended Dosing 2.0 mg OPT-302Experimental Treatment2 Interventions
2.0 mg aflibercept intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals.
2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals, with sham intravitreal injection administered at visits when OPT-302 is not.
Group III: 2.0 mg aflibercept with shamPlacebo Group2 Interventions
2.0 mg aflibercept intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals.
Sham intravitreal injection administered at 4-weekly intervals.
Find a Location
Who is running the clinical trial?
Opthea LimitedLead Sponsor
4 Previous Clinical Trials
1,560 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My eye condition is due to AMD and affects the center of my vision.You have a medical, psychological, or social condition that makes it impossible for you to participate in the study.I do not have serious eye problems that could affect vision tests or safety assessments.I have received treatment for wet age-related macular degeneration.The ETDRS BCVA score is between 60 and 25 (inclusive) letters in the Study Eye.I'm sorry, but "Main" is not a specific clinical trial exclusion criterion. Could you please provide me with more information or context?
Research Study Groups:
This trial has the following groups:- Group 1: 2.0 mg aflibercept with sham
- Group 2: 2.0 mg aflibercept with Standard Dosing 2.0 mg OPT-302
- Group 3: 2.0 mg aflibercept with Extended Dosing 2.0 mg OPT-302
Awards:
This trial has 1 awards, including:- 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.
Age-Related Macular Degeneration Patient Testimony for trial: Trial Name: NCT04757636 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can patients still join this clinical trial?
"Yes, this trial is still recruiting patients according to the information available on clinicaltrials.gov. This study was originally posted on March 12th, 2021 and was updated September 6th, 2022."
Answered by AI
What are the potential dangers associated with 2.0 aflibercept?
"There is both efficacy and safety data available for 2.0 aflibercept because it has reached Phase 3 in clinical trials. Therefore, our team rates its safety as a 3."
Answered by AI
To what medical conditions does 2.0 aflibercept offer relief?
"2.0 aflibercept can be used as treatment for various conditions including wet age-related macular degeneration (wamd), macular edema, and diabetic macular edema (dme)."
Answered by AI
What previous studies have included 2.0 aflibercept?
"In 2013, 2.0 aflibercept was first studied at Massachusetts General Hospital. As of now, 337 clinical trials have been completed and 51 are actively recruiting patients. Many of the open studies are located in Rapid City, South dakota."
Answered by AI
How many patients are meeting the requirements for this experiment?
"The website clinicaltrials.gov affirms that this research is presently looking for participants. This trial was first publicized on March 12th, 2021 and received its most recent update September 6th, 2022. A total of 990 individuals are being recruited from 57 different locations."
Answered by AI
How many different areas are conducting this experiment?
"This trial is looking for participants from a total of 57 sites, which are located in Rapid City, The Woodlands, Greenville and other surrounding areas. If you enroll in this study, it would be most convenient to select the site nearest your location to reduce travel demands."
Answered by AI
Who else is applying?
What state do they live in?
Missouri
Ohio
Florida
How old are they?
65+
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
0
What site did they apply to?
COAST Investigational Site
Other
What questions have other patients asked about this trial?
How often are the visits?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
My mom suffered with MD I always felt sad for her. I got an email and my mom has this. I am being proactive with my sight. I have beginnings of it.
PatientReceived 1 prior treatment
I've had slowly loosing vision in 1 eye now I feel it's gone to my other eye burning, itchy, dry,.
PatientReceived no prior treatments
I have been unable to get into a study for DNA transplant so I wonder if this study would help me have improved vision.
PatientReceived no prior treatments
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