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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
No Placebo-Only Group
Pivotal Trial

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~up to 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with Adverse Events (AEs)
Secondary study objectives
Number of participants with Anti-Drug Antibody (ADA) status
Pharmacokinetics (PK) of avacincaptad pegol in plasma: concentration

Awards & Highlights

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.

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.

Find a Location

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor
199 Previous Clinical Trials
122,076 Total Patients Enrolled
1 Trials studying Macular Degeneration
121 Patients Enrolled for Macular Degeneration
IVERIC bio, Inc.Lead Sponsor
4 Previous Clinical Trials
856 Total Patients Enrolled
4 Trials studying Macular Degeneration
856 Patients Enrolled for Macular Degeneration
Medical DirectorStudy ChairIVERIC bio, Inc.
2,881 Previous Clinical Trials
8,087,924 Total Patients Enrolled
19 Trials studying Macular Degeneration
1,133 Patients Enrolled for Macular Degeneration

Media Library

Avacincaptad Pegol (Antisense Oligonucleotide) Clinical Trial Eligibility Overview. Trial Name: NCT05536297 — Phase 3
Macular Degeneration Research Study Groups: avacincaptad pegol
Macular Degeneration Clinical Trial 2023: Avacincaptad Pegol Highlights & Side Effects. Trial Name: NCT05536297 — Phase 3
Avacincaptad Pegol (Antisense Oligonucleotide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05536297 — Phase 3
~37 spots leftby Mar 2025
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