Neovascular Age-related Macular DegenerationPhase 2NCT03362190
ZIMURA in Combination With LUCENTIS in Patients With Neovascular Age Related Macular Degeneration (NVAMD)
A Phase 2 study testing Avacincaptad Pegol and Lucentis in people with Neovascular Age-related Macular Degeneration, run by Ophthotech Corporation at 28 sites in 3 countries.
Trial summary
To assess the safety of intravitreal Zimura™ (complement factor C5 inhibitor) administered in combination with Lucentis® 0.5 mg in treatment naïve subjects with neovascular age related macular degeneration (NVAMD) Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- Avacincaptad Pegol and Lucentis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 28 sitesin 3 countries
- Study dates
- 11 Oct 2017to 18 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active subfoveal NVAMD
Who cannot join
- History or evidence of severe cardiac disease
- Any major surgical procedure within one month of trial entry
- Subjects with a clinically significant laboratory value
- Any treatment with an investigational agent in the past 60 days for any condition
- Women who are pregnant or nursing
- Known serious allergies to the fluorescein dye used in angiography, povidone iodine, to the components of the ranibizumab formulation, or to the components of the Zimura formulation
- Any prior treatment for AMD other than oral supplements of vitamins and minerals
Trial locations and contacts
28 sites in 3 countries.
28 sites in 3 countries
United States23 sites
Retina Research Institute of Texas
Abilene, Texas, 79606
Florida Eye Clinic
Altamonte Springs, Florida, 32701
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Retina Consultants of Orange County
Fullerton, California, 92835
Colorado Retina Associates
Golden, Colorado, 80214
Retina Consultants of Nevada
Henderson, Nevada, 89052
Charleston Neuroscience Institute
Ladson, South Carolina, 29456
Florida Eye Associates
Melbourne, Florida, 32901
VitreoRetinal Surgery
Minneapolis, Minnesota, 55435
Illinois Eye Center
Peoria, Illinois, 61615
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107
Retinal Research Institute
Phoenix, Arizona, 85053
Retina Northwest PC
Portland, Oregon, 97221
Retina Consultants of Southern California
Redlands, California, 92374
Sierra Eye Associates
Reno, Nevada, 89502
Retinal Consultants Medical Group
Sacramento, California, 95841
Orange County Retina Medical Group
Santa Ana, California, 92705
Retina Vitreous Surgeons of CNY, PC
Syracuse, New York, 13224
Retina Centers PC
Tucson, Arizona, 85704
Retina Associates SW, PC
Tucson, Arizona, 85710
Vitreo Retinal Consultants & Surgeons
Wichita, Kansas, 67214
Strategic Clinical Research Group
Willow Park, Texas, 76087
Hungary3 sites
Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont
Budapest, 1076
Budapest Retina Associates
Budapest, 1133
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szemeszeti Klinika
Szeged, 6702
Latvia2 sites
Pauls Stradins Clinical University Hospital, Clinic of Ophthalmology
Riga, LV-1002
Dr. Solomatin's eye rehabilitation and vision correction centre
Riga, LV-1050
About this study
Official title: A Phase 2A Open-label Trial to Assess the Safety of ZIMURA™ (Anti-C5) Administered in Combination With LUCENTIS® 0.5 mg in Treatment Naive Subjects With Neovascular Age Related Macular Degeneration
To assess the safety of intravitreal Zimura™ (complement factor C5 inhibitor) administered in combination with Lucentis® 0.5 mg in treatment naïve subjects with neovascular age related macular degeneration (NVAMD)
- Being tested
- Avacincaptad Pegol, Lucentis
- Keywords
- Zimura (previous name), ARC1905, Lucentis, ranibizumab, Wet AMD, avacincaptad pegol, complement factor C5 inhibitor
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
Avacincaptad Pegol in combination with Lucentis
LucentisDrug
Also called ranibizumab
Avacincaptad Pegol in combination with Lucentis
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Avacincaptad Pegol dosage 1 + Lucentis 0.5 mg Receives: Drug: Avacincaptad Pegol; Drug: Lucentis |
| Cohort 2 | Experimental | Avacincaptad Pegol dosage 2 + Lucentis 0.5 mg Receives: Drug: Avacincaptad Pegol; Drug: Lucentis |
| Cohort 3 | Experimental | Avacincaptad Pegol dosage 3 + Lucentis 0.5 mg Receives: Drug: Avacincaptad Pegol; Drug: Lucentis |
| Cohort 4 | Experimental | Avacincaptad Pegol dosage 4 + Lucentis 0.5 mg Receives: Drug: Avacincaptad Pegol; Drug: Lucentis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic Adverse Events
Number of Participants with systemic treatment-emergent Adverse Events (with calculated percentage)
Measured: 6 months
Ophthalmic Adverse Events
Number of participants with ophthalmic Adverse Events (with calculated percentage)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start11 Oct 2017
- Primary completion18 Oct 2018
- Study completion18 Oct 2018
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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ophthotech Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362190
- Sponsor's protocol ID
- OPH2007
- Status last verified
- May 2025
- First submitted
- 30 Oct 2017
- Last updated
- 10 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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/.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2A Open-label Trial to Assess the Safety of ZIMURA™ (Anti-C5) Administered in Combination With LUCENTIS® 0.5 mg in Treatment Naive Subjects With Neovascular Age Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT03362190
- Acronym / sponsor ID
- OPH2007
- Keywords
- Zimura (previous name), ARC1905, Lucentis, ranibizumab, Wet AMD, avacincaptad pegol, complement factor C5 inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ophthotech CorporationIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 18 Oct 2018 (actual)
- Study completion
- 18 Oct 2018 (actual)
- First posted
- 5 Dec 2017 (actual)
- Results
- Posted 2 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the safety of intravitreal Zimura™ (complement factor C5 inhibitor) administered in combination with Lucentis® 0.5 mg in treatment naïve subjects with neovascular age related macular degeneration (NVAMD)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Avacincaptad Pegol, Drug: LucentisAvacincaptad Pegol dosage 1 + Lucentis 0.5 mg |
| Cohort 2 | Experimental | Drug: Avacincaptad Pegol, Drug: LucentisAvacincaptad Pegol dosage 2 + Lucentis 0.5 mg |
| Cohort 3 | Experimental | Drug: Avacincaptad Pegol, Drug: LucentisAvacincaptad Pegol dosage 3 + Lucentis 0.5 mg |
| Cohort 4 | Experimental | Drug: Avacincaptad Pegol, Drug: LucentisAvacincaptad Pegol dosage 4 + Lucentis 0.5 mg |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Active subfoveal NVAMD
Key exclusion criteria (7 listed)
- History or evidence of severe cardiac disease
- Any major surgical procedure within one month of trial entry
- Subjects with a clinically significant laboratory value
- Any treatment with an investigational agent in the past 60 days for any condition
- Women who are pregnant or nursing
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, ARC1905Avacincaptad Pegol in combination with Lucentis | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| LucentisAlso: ranibizumabAvacincaptad Pegol in combination with Lucentis | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Systemic Adverse Events
Time frame: 6 months
Number of Participants with systemic treatment-emergent Adverse Events (with calculated percentage)
Ophthalmic Adverse Events
Time frame: 6 months
Number of participants with ophthalmic Adverse Events (with calculated percentage)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 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/.
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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.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Avacincaptad Pegol and Lucentis in people with Neovascular Age-related Macular Degeneration, run by Ophthotech Corporation at 28 sites in 3 countries.
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Hungary, Latvia. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 Feb 2022). 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?
Systemic Adverse Events (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2025.