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Complement Factor C5 Inhibitor
Zimura for Stargardt Disease
Phase 2
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
At least two pathogenic mutations of ABCA4 gene confirmed by a CLIA-certified laboratory
Be between 18 and 65 years old
Must not have
Macular atrophy secondary to any condition other than STGD1 in either eye
Any major surgical procedure within one month of trial entry or anticipated during the trial
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months
Summary
This trial is testing an eye injection medication to help people with Stargardt disease, a genetic condition that leads to vision loss. The medication aims to block harmful processes in the eye to prevent further vision loss.
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.
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.
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 belowSelect...
I have two harmful mutations in the ABCA4 gene.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have macular atrophy not caused by STGD1 in either eye.
Select...
I haven't had major surgery in the last month and don't expect any during the trial.
Select...
I have eye conditions like inflammation or a macular hole.
Select...
I am not pregnant or nursing.
Select...
I have not had any treatments for STGD1, including gene or stem cell therapy.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean rate of change in the area of ellipsoid zone defect
Secondary study objectives
Emergence of at least one new atrophic lesion (DDAF)
Mean change in best corrected visual acuity
Mean change in mesopic macular sensitivity
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: avacincaptad pegolExperimental Treatment1 Intervention
Participants will receive avacincaptad pegol monthly for up to 17 Months.
Group II: ShamPlacebo Group1 Intervention
Participants will receive a matching sham monthly for up to 17 Months.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Stargardt Disease, such as Avacincaptad Pegol, focus on inhibiting Complement Factor C5. This mechanism works by blocking the activation of the complement system, which is part of the immune response that can contribute to inflammation and cell damage in the retina.
By inhibiting Complement Factor C5, these treatments aim to reduce retinal inflammation and slow the progression of retinal degeneration. This is particularly important for Stargardt Disease patients as it helps preserve vision and delay the onset of severe visual impairment.
EFFICACY OF INTRAVITREAL INJECTION OF CONBERCEPT IN POLYPOIDAL CHOROIDAL VASCULOPATHY: Subgroup Analysis of the Aurora Study.Effect of lesion size, visual acuity, and lesion composition on visual acuity change with and without verteporfin therapy for choroidal neovascularization secondary to age-related macular degeneration: TAP and VIP report no. 1.
EFFICACY OF INTRAVITREAL INJECTION OF CONBERCEPT IN POLYPOIDAL CHOROIDAL VASCULOPATHY: Subgroup Analysis of the Aurora Study.Effect of lesion size, visual acuity, and lesion composition on visual acuity change with and without verteporfin therapy for choroidal neovascularization secondary to age-related macular degeneration: TAP and VIP report no. 1.
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Who is running the clinical trial?
Astellas Pharma Global Development, Inc.Lead Sponsor
200 Previous Clinical Trials
122,430 Total Patients Enrolled
IVERIC bio, Inc.Lead Sponsor
4 Previous Clinical Trials
1,013 Total Patients Enrolled
Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
2,892 Previous Clinical Trials
8,089,201 Total Patients Enrolled
4 Trials studying Stargardt Disease
50 Patients Enrolled for Stargardt Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have macular atrophy not caused by STGD1 in either eye.I have not had a stroke in the last year.I haven't had major surgery in the last month and don't expect any during the trial.I have eye conditions like inflammation or a macular hole.I am not pregnant or nursing.I have two harmful mutations in the ABCA4 gene.I have not been in a study for vitamin A derivatives in the last 3 months.I haven't had eye surgery or thermal laser treatments in the last 3 months.I have not had any treatments for STGD1, including gene or stem cell therapy.I have diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Sham
- Group 2: avacincaptad pegol
Awards:
This trial has 0 awards, including: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.
Stargardt Disease Patient Testimony for trial: Trial Name: NCT03364153 — Phase 2
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