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Antisense Oligonucleotide
Avacincaptad Pegol for Geographic Atrophy
Phase 3
Waitlist Available
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with Adverse Events (AEs)
Secondary outcome measures
Number of participants with Anti-Drug Antibody (ADA) status
Pharmacokinetics (PK) of avacincaptad pegol in plasma: concentration
Trial Design
1Treatment groups
Experimental Treatment
Group I: avacincaptad pegolExperimental Treatment1 Intervention
Participants will receive avacincaptad pegol 2 mg monthly from Month 1 to Month 17.
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Who is running the clinical trial?
Astellas Pharma Global Development, Inc.Lead Sponsor
195 Previous Clinical Trials
121,219 Total Patients Enrolled
IVERIC bio, Inc.Lead Sponsor
4 Previous Clinical Trials
856 Total Patients Enrolled
Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
2,789 Previous Clinical Trials
8,067,052 Total Patients Enrolled
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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
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.
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