Zimura for Age-Related Macular Degeneration

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
East Florida Eye Institute, Stuart, FLAge-Related Macular Degeneration+1 MoreZimura - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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 (AMD)
  • Age-Related Macular Degeneration

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Baseline, Month 6, Month 12

Month 12
Mean rate of change in GA over 12 months (measured at three time points: Baseline, Month 6, and Month 12)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Cohort 1
60%Conjunctival haemorrhage
20%Fall
20%Contusion
20%Punctate keratitis
10%Urinary tract infection
10%Vitamin B complex deficiency
10%Nasopharyngitis
10%Hiatus hernia
10%Syncope
10%Upper respiratory tract infection
10%Vitamin D deficiency
10%Laceration
10%Eye pain
10%Hypertension
10%Lacrimation increased
10%Conjunctival hyperaemia
10%Ocular discomfort
10%Intraocular pressure increased
10%Corneal abrasion
10%Subretinal fibrosis
10%Neovascular age-related macular degeneration
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT03362190) in the Cohort 1 ARM group. Side effects include: Conjunctival haemorrhage with 60%, Fall with 20%, Contusion with 20%, Punctate keratitis with 20%, Urinary tract infection with 10%.

Trial Design

2 Treatment Groups

Zimura Treatment Group
1 of 2
Sham Treatment Group
1 of 2

Experimental Treatment

Non-Treatment Group

448 Total Participants · 2 Treatment Groups

Primary Treatment: Zimura · Has Placebo Group · Phase 3

Zimura Treatment Group
Drug
Experimental Group · 1 Intervention: Zimura · Intervention Types: Drug
Sham Treatment Group
Drug
ShamComparator Group · 1 Intervention: Sham · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avacincaptad pegol
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, month 6, month 12

Who is running the clinical trial?

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

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
California28.6%
Florida28.6%
Ontario14.3%
Other28.6%
How old are they?
65+100.0%
What site did they apply to?
Retinal Consultants Medical Group, Inc.50.0%
Ochsner Medical Center50.0%
What portion of applicants met pre-screening criteria?
Met criteria71.4%
Did not meet criteria28.6%
Why did patients apply to this trial?
  • "More loss of vision with dirt macular degeneration. Diagnosed in 2019. Slowly progressing according to my ophthalmologist in last exam earlier in February. 2023. However, in the last 4 to 5 months I know my vision is worse. Now can’t read a newspaper, or most text without bright light and a magnifying glass. Getting very frustrating and depressed about mY AMD."
How many prior treatments have patients received?
0100.0%

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.