Idiopathic Polypoidal Choroidal VasculopathyPhase 2NCT03374670
ZIMURA in Combination With Eylea in Patients With Idiopathic Polypoidal Choroidal Vasculopathy (IPCV)
A Phase 2 study testing Zimura and Eylea in people with Idiopathic Polypoidal Choroidal Vasculopathy, run by Ophthotech Corporation at 1 site in United States.
Trial summary
To asses the safety of intravitreal Zimura™ (complement factor C5 inhibitor) administered in combination with Eylea® in treatment experienced subjects with idiopathic polypoidal choroidal vasculopathy Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Idiopathic Polypoidal Choroidal Vasculopathy
- What is being tested?
- Zimura and Eylea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2018to Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Diagnosis of IPCV
- Patients must have had 3 sequential Eylea injections within the previous 4 months
Who cannot join
- Intravitreal treatment in the study eye prior to screening, regardless of indication, except 3 prior injections of Eylea
- 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, ICG dye, iodine, povidone iodine, or to the components or formulation of either Zimura or Eylea
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2A Open-Label Trial to Assess the Safety of ZIMURA™ (Anti-C5) in Combination With EYLEA® in Treatment Experienced Subjects With Idiopathic Polypoidal Choroidal Vasculopathy
To asses the safety of intravitreal Zimura™ (complement factor C5 inhibitor) administered in combination with Eylea® in treatment experienced subjects with idiopathic polypoidal choroidal vasculopathy
- Being tested
- Zimura, Eylea
- Keywords
- Zimura, ARC1905, Eylea, aflibercept, IPCV, avacincaptad pegol, complement factor C5 inhibitor
- Medical subject headings
- Polypoidal Choroidal Vasculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZimuraDrug
Also called avacincaptad pegol
Zimura in combination with Eylea
EyleaDrug
Also called aflibercept
Zimura in combination with Eylea
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Zimura dosage 1 + Eylea 2 mg Receives: Drug: Zimura; Drug: Eylea |
| Cohort 2 | Experimental | Zimura dosage 2 + Eylea 2 mg Receives: Drug: Zimura; Drug: Eylea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
AEs
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study startNov 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: No patients were enrolled. Study terminated for portfolio reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Polypoidal Choroidal VasculopathyStudies 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
- 0 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
- NCT03374670
- Sponsor's protocol ID
- OPH2006
- Status last verified
- Sep 2018
- First submitted
- 11 Dec 2017
- Last updated
- 21 Feb 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. 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) in Combination With EYLEA® in Treatment Experienced Subjects With Idiopathic Polypoidal Choroidal Vasculopathy
- ClinicalTrials.gov ID
- NCT03374670
- Acronym / sponsor ID
- OPH2006
- Keywords
- Zimura, ARC1905, Eylea, aflibercept, IPCV, avacincaptad pegol, complement factor C5 inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients were enrolled. Study terminated for portfolio reasons.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ophthotech CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 15 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To asses the safety of intravitreal Zimura™ (complement factor C5 inhibitor) administered in combination with Eylea® in treatment experienced subjects with idiopathic polypoidal choroidal vasculopathy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Zimura, Drug: EyleaZimura dosage 1 + Eylea 2 mg |
| Cohort 2 | Experimental | Drug: Zimura, Drug: EyleaZimura dosage 2 + Eylea 2 mg |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of IPCV
- Patients must have had 3 sequential Eylea injections within the previous 4 months
Key exclusion criteria (7 listed)
- Intravitreal treatment in the study eye prior to screening, regardless of indication, except 3 prior injections of Eylea
- 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
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 |
|---|---|---|
| ZimuraAlso: avacincaptad pegolZimura in combination with Eylea | Drug | Cohort 1, Cohort 2 |
| EyleaAlso: afliberceptZimura in combination with Eylea | Drug | Cohort 1, Cohort 2 |
Primary outcome
Adverse Events (AEs)
Time frame: 9 months
AEs
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zimura and Eylea in people with Idiopathic Polypoidal Choroidal Vasculopathy, run by Ophthotech Corporation at 1 site in United States.
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 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: withdrawn, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Adverse Events (AEs) (time frame: 9 months). 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 21 Feb 2024.