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Antisense Oligonucleotide
Avacincaptad Pegol for Geographic Atrophy
Phase 3
Waitlist Available
Research Sponsored by IVERIC bio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female patients aged 50 years or greater diagnosed with GA inside and/or outside of the fovea who completed Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 18
Awards & highlights
Study Summary
This trial will test a new medication for patients with myelofibrosis. The medication will be given monthly, and the trial will monitor the effects.
Who is the study for?
This trial is for patients aged 50 or older with a condition called Geographic Atrophy, who completed the GATHER2 study. They must be able to attend all visits over an 18-month period and not have dropped out of the previous study due to side effects.Check my eligibility
What is being tested?
The trial involves monthly injections of Avacincaptad pegol (2 mg) directly into the eye. It's designed for those who've already received this treatment in a prior study and aims to further evaluate its long-term effects.See study design
What are the potential side effects?
While specific side effects are not listed here, intravitreal injections like Avacincaptad pegol can cause eye irritation, redness, discomfort, possible bleeding inside the eye, and increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 50 or older with GA and finished the GATHER2 study up to Month 24.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 18
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 18
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events
Trial Design
1Treatment groups
Experimental Treatment
Group I: Avacincaptad pegol 2 mgExperimental Treatment1 Intervention
Avacincaptad pegol 2 mg administered monthly from Month 1 to Month 17
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Who is running the clinical trial?
IVERIC bio, Inc.Lead Sponsor
4 Previous Clinical Trials
855 Total Patients Enrolled
Medical DirectorStudy ChairIVERIC bio, Inc.
2,769 Previous Clinical Trials
8,061,922 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never been removed from the ISEE2008 study due to side effects.I am 50 or older with GA and finished the GATHER2 study up to Month 24.
Research Study Groups:
This trial has the following groups:- Group 1: Avacincaptad pegol 2 mg
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 we still recruiting new participants for this research?
"Sadly, this particular clinical trial is not currently looking for patients. Although the trial's most recent update was on September 26th, 2022, the study is not currently recruiting. However, there are 329 other trials that are currently looking for patients."
Answered by AI
Has the FDA cleared Avacincaptad pegol 2 mg intravitreal injection for use?
"Avacincaptad pegol 2 mg intravitreal injection receives a safety score of 3 from our Power team. This is due to it being a Phase 3 trial, meaning that, while there is some efficacy data, there is more supporting data for its safety."
Answered by AI
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