Neovascular Age-Related Macular DegenerationPhase 2NCT05571267

Safety Study of Zimura in Combination With Anti-VEGF Therapy in Patients With Neovascular AMD

A Phase 2 study testing Avacincaptad Pegol, Avastin and Lucentis in people with Neovascular Age-Related Macular Degeneration, run by IVERIC bio, Inc..

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The primary objective is to assess the safety of intravitreal (IVT) Zimura® administered in combination with anti-VEGF Therapy (AVASTIN®, EYLEA®, OR LUCENTIS®) in anti-VEGF treatment experienced subjects with neovascular age-related macular degeneration (AMD) Read more about this study

Who is it for?: Ages 50 to 80 years
Conditions the study is for: Neovascular Age-Related Macular Degeneration
What is being tested?: Avacincaptad Pegol, Avastin and Lucentis
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: No sites listed yet
Study dates: 20 Oct 2016to 24 Apr 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Treatment experienced subjects defined as subjects with 1 prior dose of same intravitreal anti-VEGF therapy given within the past 8 weeks for neovascular age-related macular degeneration (NVAMD) in the study eye. There must be < 0 letters of improvement in Snellen (not ETDRS Snellen equivalent) visual acuity since the start of anti-VEGF treatment.
Presence of subfoveal active choroidal neovascularization (CNV)

Who cannot join

Intravitreal treatment in the study eye prior to the Day 1 visit, regardless of indication, with the exception of the 1 prior anti-VEGF injections.
Presence of other causes of choroidal neovascularization, including pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis.
Non-pharmacologic treatment (intraocular surgery or thermal laser) within three months of trial entry.
Prior thermal laser in the macular region, regardless of indication.
Ocular or periocular infection in the past twelve weeks.
History of any of the following conditions or procedures in the study eye: rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery, glaucoma drainage device, or corneal transplant.
Previous therapeutic radiation in the region of the study eye.
Evidence of diabetic retinopathy

About this study

Official title: A Phase 2A Randomized Open-Label Controlled Trial to Assess the Safety of Zimura™ (Anti-C5 Aptamer) Administered in Combination With Anti-VEGF Therapy in Treatment Experienced Patients With Neovascular Age-Related Macular Degeneration

Conditions: Neovascular Age-Related Macular Degeneration
Being tested: Avacincaptad Pegol, Avastin, Lucentis, Eylea
Keywords: Neovascular age-related macular degeneration (NVAMD)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Avacincaptad PegolDrug
Also called Zimura (previous name), IZERVAY, ARC1905
Zimura 2 mg, administered by intravitreal injection
AvastinDrug
Also called Bevacizumab
Avastin 1.25 mg, administered by intravitreal injection
LucentisDrug
Also called Ranibizumab
Lucentis 0.5 mg, administered by intravitreal injection
EyleaDrug
Also called Aflibercept
Eylea 2 mg, administered by intravitreal injection

Study groups in NCT05571267
Study group	Role	What they receive
Avacincaptad Pegol and Avastin	Experimental	Participants receive three monthly Avastin treatments (Day 1, Month 1, and Month 2) followed by Avacincaptad Pegol administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Avastin and Avacincaptad Pegol. Receives: Drug: Avacincaptad Pegol; Drug: Avastin
Avacincaptad Pegol and Lucentis	Experimental	Participants receive three monthly Lucentis treatments (Day 1, Month 1, and Month 2) followed by Avacincaptad Pegol administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Lucentis and Avacincaptad Pegol. Receives: Drug: Avacincaptad Pegol; Drug: Lucentis
Avacincaptad Pegol and Eylea	Experimental	Participants receive three monthly Eylea treatments (Day 1, Month 1, and Month 2) followed by Avacincaptad Pegol administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Eylea and Avacincaptad Pegol. Receives: Drug: Avacincaptad Pegol; Drug: Eylea

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With >0 Letter Loss
Vision testing is performed using retroilluminated modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts at 4 meters. Observed VA loss at Month 12 from Day 1 was assessed.
Measured: Month 12
Percentage of Participants With >0 Letter Loss
Vision testing is performed using retroilluminated modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts at 4 meters. Observed VA loss at Month 18 from Day 1 was assessed.
Measured: Month 18
Percentage of Participants With >5 Letter Loss
Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters. Observed VA loss at Month 12 from Day 1 was assessed.
Measured: Month 12
Percentage of Participants With >5 Letter Loss
Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters. Observed VA loss at Month 18 from Day 1 was assessed.
Measured: Month 18
Percentage of Participants With >10 Letter Loss
Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters. Observed VA loss at Month 12 from Day 1 was assessed.
Measured: Month 12
Percentage of Participants With >10 Letter Loss
Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters. Observed VA loss at Month 18 from Day 1 was assessed.
Measured: Month 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Oct 201624 Apr 2018

First posted7 Oct 2022
Study start20 Oct 2016
Primary completion24 Apr 2018
Study completion24 Apr 2018

Why it stopped: Following Sponsor reassessment, OPH2004 enrollment was stopped to initiate a new Zimura wet AMD trial, OPH2007, for treatment-naïve patients. Thus, only one patient was enrolled into and completed Study OPH2004.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Neovascular Age-Related Macular DegenerationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05571267
Sponsor's protocol ID: OPH2004
Status last verified: Mar 2025
First submitted: 28 Sep 2022
Last updated: 13 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 3
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 1/2
Phase 1/2 Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Age-Related Macular Degeneration, Geographic Atrophy
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAK
Wet Age-related Macular Degeneration
Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of VIS-101 in Participants With Neovascular Age-Related Macular Degeneration
Neovascular Age Related Macular Degeneration(nAMD)

All Neovascular Age-Related Macular Degeneration trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2A Randomized Open-Label Controlled Trial to Assess the Safety of Zimura™ (Anti-C5 Aptamer) Administered in Combination With Anti-VEGF Therapy in Treatment Experienced Patients With Neovascular Age-Related Macular Degeneration
ClinicalTrials.gov ID: NCT05571267
Acronym / sponsor ID: OPH2004
Conditions: Neovascular Age-Related Macular Degeneration
Keywords: Neovascular age-related macular degeneration (NVAMD)
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Following Sponsor reassessment, OPH2004 enrollment was stopped to initiate a new Zimura wet AMD trial, OPH2007, for treatment-naïve patients. Thus, only one patient was enrolled into and completed Study OPH2004.
Enrolment: 1 participants (actual)
Lead sponsor: IVERIC bio, Inc.Industry (pharma, biotech, devices)
Study start: 20 Oct 2016 (actual)
Primary completion: 24 Apr 2018 (actual)
Study completion: 24 Apr 2018 (actual)
First posted: 7 Oct 2022 (actual)
Results: Posted 3 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Avacincaptad Pegol and Avastin	Experimental	Drug: Avacincaptad Pegol, Drug: AvastinParticipants receive three monthly Avastin treatments (Day 1, Month 1, and Month 2) followed by Avacincaptad Pegol administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Avastin and Avacincaptad Pegol.
Avacincaptad Pegol and Lucentis	Experimental	Drug: Avacincaptad Pegol, Drug: LucentisParticipants receive three monthly Lucentis treatments (Day 1, Month 1, and Month 2) followed by Avacincaptad Pegol administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Lucentis and Avacincaptad Pegol.
Avacincaptad Pegol and Eylea	Experimental	Drug: Avacincaptad Pegol, Drug: EyleaParticipants receive three monthly Eylea treatments (Day 1, Month 1, and Month 2) followed by Avacincaptad Pegol administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Eylea and Avacincaptad Pegol.

Who may qualify

Ages: 50 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Treatment experienced subjects defined as subjects with 1 prior dose of same intravitreal anti-VEGF therapy given within the past 8 weeks for neovascular age-related macular degeneration (NVAMD) in the study eye. There must be < 0 letters of improvement in Snellen (not ETDRS Snellen equivalent) visual acuity since the start of anti-VEGF treatment.
Presence of subfoveal active choroidal neovascularization (CNV)

Key exclusion criteria (8 listed)

Intravitreal treatment in the study eye prior to the Day 1 visit, regardless of indication, with the exception of the 1 prior anti-VEGF injections.
Presence of other causes of choroidal neovascularization, including pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis.
Non-pharmacologic treatment (intraocular surgery or thermal laser) within three months of trial entry.
Prior thermal laser in the macular region, regardless of indication.
Ocular or periocular infection in the past twelve weeks.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Avacincaptad PegolAlso: Zimura (previous name), IZERVAY, ARC1905Zimura 2 mg, administered by intravitreal injection	Drug	Avacincaptad Pegol and Avastin, Avacincaptad Pegol and Eylea, Avacincaptad Pegol and Lucentis
AvastinAlso: BevacizumabAvastin 1.25 mg, administered by intravitreal injection	Drug	Avacincaptad Pegol and Avastin
LucentisAlso: RanibizumabLucentis 0.5 mg, administered by intravitreal injection	Drug	Avacincaptad Pegol and Lucentis
EyleaAlso: AfliberceptEylea 2 mg, administered by intravitreal injection	Drug	Avacincaptad Pegol and Eylea

Primary outcome

Percentage of Participants With >0 Letter Loss
Time frame: Month 12
Vision testing is performed using retroilluminated modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts at 4 meters. Observed VA loss at Month 12 from Day 1 was assessed.
Percentage of Participants With >0 Letter Loss
Time frame: Month 18
Vision testing is performed using retroilluminated modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts at 4 meters. Observed VA loss at Month 18 from Day 1 was assessed.
Percentage of Participants With >5 Letter Loss
Time frame: Month 12
Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters. Observed VA loss at Month 12 from Day 1 was assessed.
Percentage of Participants With >5 Letter Loss
Time frame: Month 18
Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters. Observed VA loss at Month 18 from Day 1 was assessed.
Percentage of Participants With >10 Letter Loss
Time frame: Month 12
Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters. Observed VA loss at Month 12 from Day 1 was assessed.
Percentage of Participants With >10 Letter Loss
Time frame: Month 18
Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters. Observed VA loss at Month 18 from Day 1 was assessed.

Results and safety

Results posted to the registry on 3 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Zimura and Avastin	1	1
Zimura and Lucentis	0	0
Zimura and Eylea	0	0

Primary outcome: Percentage of Participants With >0 Letter Loss

Time frame: Month 12. Number. Unit: percentage of participants

Measure	Zimura and Avastin n = 1	Zimura and Lucentis n = 0	Zimura and Eylea n = 0
Value	0	–	–

Population analysed: Only one patient was enrolled into Study OPH2004. This participant was included in the Zimura and Avastin arm. There were no participants in the Zimura and Lucentis arm and there were no participants in the Zimura and Eylea arm.

Primary outcome: Percentage of Participants With >0 Letter Loss

Time frame: Month 18. Number. Unit: percentage of participants

Measure	Zimura and Avastin n = 1	Zimura and Lucentis n = 0	Zimura and Eylea n = 0
Value	0	–	–

Primary outcome: Percentage of Participants With >5 Letter Loss

Time frame: Month 12. Number. Unit: percentage of participants

Measure	Zimura and Avastin n = 1	Zimura and Lucentis n = 0	Zimura and Eylea n = 0
Value	0	–	–

Primary outcome: Percentage of Participants With >5 Letter Loss

Time frame: Month 18. Number. Unit: percentage of participants

Measure	Zimura and Avastin n = 1	Zimura and Lucentis n = 0	Zimura and Eylea n = 0
Value	0	–	–

Adverse events

Time frame: Starting on Day 1, after first dose of trial drug, and continuing until 30 days after the last dose or until the last follow-up visit required by the protocol, whichever comes later, up to approximately 18 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Zimura and Avastin	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Zimura and Lucentis	0 of 0	0 of 0	0
Zimura and Eylea	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): Following the Sponsor's reassessment of the Zimura development program, enrollment was stopped in this trial as the Sponsor determined that they would initiate a new Zimura wet AMD trial, the OPH2007 trial, for treatment-naïve patients. Therefore, a total of two patients were screened, one of whom was a screen failure. Thus, only one patient was enrolled into Study OPH2004.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Link to plain language summary of the study on the Trial Results Summaries websiteLink provided by the sponsor.
Link to results and other applicable study documents on the Astellas Clinical Trials websiteLink provided by the sponsor.
Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Related trials for Neovascular Age-Related Macular Degeneration

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Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

IVERIC bio, Inc.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Avacincaptad Pegol, Avastin and Lucentis in people with Neovascular Age-Related Macular Degeneration, run by IVERIC bio, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With >0 Letter Loss (time frame: Month 12). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05571267.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.