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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Vaccination against Neisseria meningitidis and Streptococcus pneumoniae received at least 2 weeks prior to first dose of investigational product
Well-demarcated geographic atrophy (GA) due to AMD
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upweek 49
Awards & highlights
Study Summary
This trial is testing a new treatment for AMD to see if it can slow the rate of growth of GA.
Eligible Conditions
- Age-Related Macular Degeneration
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 49
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 49
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Absolute Change from Baseline in the Geographic Atrophy (GA) Area at Week 49, as Assessed by Retinal Imaging
Secondary outcome measures
Absolute Change from Baseline in Low Luminance Visual Acuity (LLVA)
Percentage Change from Baseline in Levels of Factor B (FB) in Plasma
Percentage Change from Baseline in Levels of Serum AH50 Activity
Trial Design
2Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
Stage 1 participants will receive a placebo matching solution, administered subcutaneously every 4 weeks, completing the treatment period at Week 45. Stage 2 participants will receive a placebo matching solution, administered subcutaneously every 4 weeks, completing the treatment period at Week 45.
Group II: IONIS-FB-LRxExperimental Treatment1 Intervention
Stage 1 participants will receive IONIS-FB-LRx randomized to 1 of 3 dose levels, administered subcutaneously every 4 weeks, completing the treatment period at Week 45. Stage 2 will expand 2 of the dosing cohorts in a new randomized group of participants based on the Stage 1 interim analysis. Participants will be randomized to 1 of 2 of the expanded cohorts, administered subcutaneously every 4 weeks, completing the treatment period at Week 45.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Ionis Pharmaceuticals, Inc.Lead Sponsor
143 Previous Clinical Trials
14,863 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The person taking the photograph must have clear vision and the pupil of their eye must be dilated enough to take a clear picture of the fundus.You have been taking steroids for a long time, either through skin application or injection into the eye.You have had an infection within the last 14 days and have not fully recovered from it.Females must not be pregnant or lactating, and must have had a surgical procedure to make them sterile or have gone through menopause.You have a medical condition, other than AMD, that could impact your vision or safety during the trial.You have previously been treated with an experimental medication, biological product, or medical device.There may be additional requirements for inclusion or exclusion from the study that are not listed here but will be specified in the study protocol.The person had a BCVA letter score of 35 letters or better on the ETDRS chart.
Research Study Groups:
This trial has the following groups:- Group 1: IONIS-FB-LRx
- Group 2: Placebo
Awards:
This trial has 0 awards, including: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: NCT03815825 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many healthcare facilities are actively administering this trial?
"64 medical institutions, such as VCH/UBC Eye Care Center in Vancouver, Cumberland Valley Retina Consultants in Hagerstown and USF Eye Institute in Tampa are all conducting this trial."
Answered by AI
Are there still open slots for participants in this research endeavor?
"Affirmative. Clinicaltrials.gov confirms that this clinical trial, initially posted on March 4th 2019, is actively recruiting 330 patients from 64 sites across the world."
Answered by AI
What is the projected enrollment rate for this research trial?
"This clinical trial necessitates 330 suitable patients to participate. Prospective participants can sign up at the VCH/UBC Eye Care Center in Vancouver, British Columbia or Cumberland Valley Retina Consultants in Hagerstown, Maryland."
Answered by AI
Has the IONIS-FB-LRx drug been sanctioned by the FDA?
"There is limited evidence of IONIS-FB-LRx's safety, hence it was awarded a score of 2."
Answered by AI
Who else is applying?
What state do they live in?
Florida
California
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
What site did they apply to?
Retina-Vitreous Associates Medical Group
Blue Ocean Clinical Research at the Macula Center
University of California, Irvine
Other
Why did patients apply to this trial?
i am getting eye injections. I am hoping to add to the knowledge about AMD treatments. I am a retired epidemiologist-.
PatientReceived no prior treatments
I have recently been diagnosed with dry MD. I want to do all I can to keep from getting weeks.
PatientReceived 2+ prior treatments
I have it in my left eye, and I received one injection in March 2023. But I stopped because of financial situation. Is it still for possible to do a clinical trial?
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long does it tske? Is their more than 1 trial I may qualify for?
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- IONIS Investigative Site: < 48 hours
Average response time
- < 2 Days
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