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Complement C5 Inhibitor

Avacincaptad Pegol Treatment Group for Age-Related Macular Degeneration

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and month 12
Awards & highlights

Study Summary

This trial is testing a new medication to see if it is safe and effective for people with a certain eye condition.

Eligible Conditions
  • Age-Related Macular Degeneration

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and month 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Rate of Change in GA Over 12 Months (Measured at Three Time Points: Baseline, Month 6, and Month 12)

Side effects data

From 2023 Phase 3 trial • 448 Patients • NCT04435366
12%
Conjunctival haemorrhage
9%
Intraocular pressure increased
6%
Fall
6%
Urinary tract infection
5%
Conjunctival hyperaemia
5%
Punctate keratitis
5%
Choroidal neovascularisation
1%
Pneumonia
1%
Atrial fibrillation
1%
Pulmonary embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Avacincaptad Pegol Treatment Group
Sham Treatment Group

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Avacincaptad Pegol Treatment GroupExperimental Treatment1 Intervention
Monthly avacincaptad pegol 2mg intravitreal injections through Month 11 (Year 1) NOTE: At Month 12, participants are re-randomized to receive monthly injections or every other month injections (alternating with sham) from Month 12 to Month 23 (Year 2) - Year 2 is not included in the primary analysis.
Group II: Sham Treatment GroupPlacebo Group1 Intervention
Monthly sham administration through Month 11 (Year 1) NOTE: At Month 12, participants continue to receive monthly sham administration from Month 12 to Month 23 (Year 2) - Year 2 is not included in the primary analysis.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avacincaptad Pegol
2020
Completed Phase 3
~450

Find a Location

Who is running the clinical trial?

IVERIC bio, Inc.Lead Sponsor
4 Previous Clinical Trials
685 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Zimura a new medication or has it been tested before?

"There are currently two ongoing clinical trials for Zimura, one of which is in the third and final phase. Zimura is being studied at many research centres around the world, with a particular focus in France."

Answered by AI

Will Zimura have any harmful side effects for patients?

"Zimura's safety is estimated to be a 3, as it is a Phase 3 trial. This suggests that, not only is there some evidence of the medication's efficacy, but that there are also multiple rounds of data supporting its safety."

Answered by AI

Do we have previous data to support the efficacy of this trial?

"Zimura is being studied in 2 ongoing trials spanning 114 cities and 20 countries. Zimura's first study was completed in 2018. IVERIC bio, Inc. sponsored the Phase 2 clinical trial which involved 120 patients. As of 2018, a total of 116 studies have been completed."

Answered by AI

Are there any current openings for patients who might want to enroll in this trial?

"The study is not recruiting patients at this time, as indicated on clinicaltrials.gov. The trial was posted on June 22, 2020 and last updated on September 26, 2020. There are 330 other trials that are currently accepting patients."

Answered by AI

Could you please tell us how many different hospitals are trialing this medication?

"At the moment, this trial is taking place at 100 locations, many of which are in New york (Slingerlands, Bloomfield), but also in other cities. If you decide to participate in this trial, choose a location near to reduce travel time and costs."

Answered by AI

Who else is applying?

What state do they live in?
Ontario
Florida
California
Other
How old are they?
65+
What site did they apply to?
Retinal Consultants Medical Group, Inc.
University Health Network
Ochsner Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0

What questions have other patients asked about this trial?

Where will screen tests be conducted? How long do screening tests take? Are the tests painful? Will I be able to continue and work during screening?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

Injections for wet AMD were successful to the extent that now both eyes have dry AMD. I am looking for something to extend the period of time that I can see.
PatientReceived 2+ prior treatments
I have been told to take AREDS. I am informed that in Canada, there are no treatments for AMD and I have to get accepted for clinical trial. I am also worried that I may become blind, and I understand that AMD degeneration can be slowed down if trials turn positive in my case.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)
2020. "A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04435366.
~93 spots leftby Apr 2025
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