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Complement Factor C5 Inhibitor

Zimura for Stargardt Disease

Phase 2
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
At least two pathogenic mutations of ABCA4 gene confirmed by a CLIA-certified laboratory
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective for people with a certain type of eye disease.

Who is the study for?
This trial is for individuals with Stargardt Disease who have a visual acuity between 20/20 and 20/200, and two confirmed mutations of the ABCA4 gene. It's not for those who've had recent eye surgery, diabetes, stroke within the last year, or major surgery planned during the trial. Pregnant or nursing women and people with certain allergies or other eye conditions are also excluded.Check my eligibility
What is being tested?
The study is testing Zimura™ (a complement factor C5 inhibitor) against a sham treatment to see if it's safe and effective in treating autosomal recessive Stargardt disease (STGD1). Participants will be randomly assigned to receive either Zimura or a placebo-like procedure without active medication.See study design
What are the potential side effects?
While specific side effects of Zimura aren't listed here, similar treatments may cause injection-related reactions like redness or discomfort at the site of injection, potential allergic reactions, increased risk of infection due to immune system suppression, and possibly inflammation inside the eye.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have two harmful mutations in the ABCA4 gene.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Spectral Domain-Optical Coherence Tomography (SD-OCT)

Side effects data

From 2020 Phase 2 & 3 trial • 286 Patients • NCT02686658
12%
Conjunctival haemorrhage *
9%
Urinary tract infection
7%
Visual acuity reduced*
7%
Punctate keratitis*
6%
Fall
5%
Vitreous detachment*
5%
Eye irritation*
5%
Cataract*
5%
Nasopharyngitis
4%
Conjunctival hyperaemia*
4%
Neovascular age-related macular degeneration*
4%
Conjunctival oedema*
4%
Hypertension
3%
Eye pain*
3%
Chronic obstructive pulmonary disease
3%
Choroidal neovascularization*
3%
Laceration
3%
Coronary artery disease
3%
Sinusitis
2%
Upper respiratory tract infection
2%
Posterior capsule opacification*
2%
Influenza
2%
Contusion
2%
Rhinitis
2%
Spinal column stenosis
2%
Hypokalaemia
1%
Lung neoplasm malignant
1%
Gastrointestinal haemorrhage
1%
Lumbar radiculopathy
1%
Small intestinal obstruction
1%
Osteoarthritis
1%
Appendiceal mucocoele
1%
Pneumothorax
1%
Pancreatic carcinoma metastatic
1%
Pneumonia
1%
Cerebral haemorrhage
1%
Breast cancer
1%
Pneumonia aspiration
1%
Back pain
1%
Cerebrovascular accident
1%
Lung cancer metastatic
1%
Cardiac failure congestive
1%
Abdominal hernia
1%
Diarrhoea
1%
Faecaloma
1%
Gastrooesophageal reflux disease
1%
Large intestinal stenosis
1%
Head injury
1%
Upper limb fracture
1%
Hyperglycaemia
1%
Hyponatraemia
1%
Lumbar spinal stenosis
1%
Hallucination
1%
Respiratory distress
1%
Subclavian artery stenosis
1%
Intraocular pressure increased
1%
Metastases to adrenals
1%
Metastases to central nervous system
1%
Ischaemic stroke
1%
Anxiety
1%
Cholecystitis
1%
Femur fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sham [Part 1 & Part 2 Combined]
Zimura 2 mg (Zimura 2mg+Sham) [Part 2]
Zimura 1 mg [Part 1]
Zimura (Any Dose) [Part 1 & Part 2 Combined]
Zimura 2 mg [Part 1]
Sham [Part 1]
Sham (Sham+Sham) [Part 2]
Zimura 4 mg (Zimura 2mg+Zimura 2mg) [Part 2]

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort 1Experimental Treatment1 Intervention
Zimura dose group
Group II: Cohort 2Placebo Group1 Intervention
Sham dose group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avacincaptad pegol
Not yet FDA approved

Find a Location

Who is running the clinical trial?

IVERIC bio, Inc.Lead Sponsor
4 Previous Clinical Trials
1,013 Total Patients Enrolled

Media Library

Zimura (Complement Factor C5 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03364153 — Phase 2
Stargardt Disease Research Study Groups: Cohort 1, Cohort 2
Stargardt Disease Clinical Trial 2023: Zimura Highlights & Side Effects. Trial Name: NCT03364153 — Phase 2
Zimura (Complement Factor C5 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03364153 — Phase 2
Stargardt Disease Patient Testimony for trial: Trial Name: NCT03364153 — Phase 2

Frequently Asked Questions

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

Who would this clinical trial be most appropriate for?

"This study is only open to people with stargardt disease who are between 18 and 60 years old. Up to 120 participants will be accepted in total."

Answered by AI

Can patients currently sign up for this trial?

"That is accurate. The clinical trial in question, which is posted on clinicaltrials.gov, is currently looking for 120 patients from 15 different sites. This particular study was first made public on 1/12/2018 with the most recent update coming on 9/7/2022."

Answered by AI

How many people are part of this experiment?

"That is accurate. The clinical trial in question, which was first posted on 1/12/2018 and last updated on 9/7/2022, is still recruiting patients. So far, 15 different sites have enrolled 120 people total."

Answered by AI

Is this a new method being trialed?

"As of now, there are 2 ongoing clinical trials for Zimura in 114 different cities and 20 countries. The first trial was completed in 2018 and involved 120 patients. IVERIC bio, Inc. sponsored the study and it reached Phase 2 approval. Since then, 116 more studies have been conducted."

Answered by AI

To what extent has Zimura been studied in other scientific investigations?

"Zimura was first studied in 2018 at Moorfields Eye Hospital. Since the completion of that study, there have been a total of 116 clinical trials investigating the medication. As of now, there are 2 active studies recruiting patients. These research sites are located in West Columbia, South carolina."

Answered by AI

Does this research allow for elderly participation?

"In order to meet the requirements for this specific trial, applicants must be aged 18-60. If you are not in this age bracket, there are 11 other trials that might better suit your needs if you're under 18 and 164 options if you're over 65."

Answered by AI

Has the US Food and Drug Administration cleared Zimura for use?

"Zimura's safety was scored a 2 because, while there is some data supporting its safety, Phase 2 trials have yet to demonstrate efficacy."

Answered by AI

How many offices are handling this experiment?

"A few of the 15 locations where this trial is taking place are Palmetto Retina Center in West Columbia, South carolina, Envision Ocular, LLC in Bloomfield, New jersey, and Retina Foundation of the Southwest in Dallas, Texas."

Answered by AI

Who else is applying?

What state do they live in?
New York
Ohio
California
Other
How old are they?
65+
< 18
18 - 65
What site did they apply to?
Jules Stein Eye Institute/ David Geffen School of Medicine
Kellogg Eye Center
Retina Center of New Jersey, LLC
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

When will it start?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I was diagnosed at 38 years old and have a slow progressikn. I found out of my diagnosis three years ago at the age of 14. I have applied for the Dragon Trial Phase III at Stanford Belite Bio LBS-008. I did not meet the minimum requirements so am trying to find a trial that may work for me.
PatientReceived 1 prior treatment
I have the autosomal recessive form of Stargardt (bullseye) degeneration. I tested positive for this 2 yrs ago. I also take injections for wet and. I have been told that due to the injection I do not qualify, but I have the Stargardt is both eyes.
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Most responsive sites:
  1. Jules Stein Eye Institute/ David Geffen School of Medicine: < 48 hours
Recent research and studies
clinicaltrials.govStudy
Zimura Compared to Sham in Patients With Autosomal Recessive Stargardt Disease (STGD1)
2018. "Zimura Compared to Sham in Patients With Autosomal Recessive Stargardt Disease (STGD1)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03364153.
All > Age Related Macular Degeneration > Stargardt Disease
~14 spots leftby Apr 2025
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