Idiopathic Polypoidal Choroidal VasculopathyPhase 2NCT02397954
A Study to Establish the Safety and Tolerability of Zimura™ (Anti-C5 Aptamer) in Combination With Anti-VEGF Therapy in Subjects With Idiopathic Polypoidal Choroidal Vasculopathy (IPCV)
A Phase 2 study testing Avacincaptad Pegol in people with Idiopathic Polypoidal Choroidal Vasculopathy, run by Ophthotech Corporation at 1 site in United States.
Trial summary
The objectives of this study are to evaluate the safety and tolerability of Zimura™ intravitreous injection in combination with anti-vascular endothelial growth factor (VEGF) therapy in subjects with Idiopathic Polypoidal Choroidal Vasculopathy (IPCV). 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?
- Avacincaptad Pegol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2015to 23 Oct 2015
- 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
- Subjects of either gender aged ≥ 50 years
- Diagnosis of IPCV
- Treatment-experienced defined as prior treatment with anti-VEGF mono therapy of ≥ 8 injections in the previous twelve (12) months
Who cannot join
- Any intraocular surgery or thermal laser within three (3) months of trial entry
- Any prior thermal laser in the macular region, regardless of indication
- Any ocular or periocular infection in the twelve (12) weeks prior to entry
- History of any of the following conditions or procedures in the study eye: Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant
- Previous therapeutic radiation in the region of the study eye
- A diagnosis of diabetic retinopathy (presence of microaneurysms or any vasculopathy and/or leakage from retinal vasculature in a subject with diabetes mellitus)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2a Study to Establish the Safety and Tolerability of Zimura™ (Anti-C5 Aptamer) in Combination With Anti-VEGF Therapy in Subjects With Idiopathic Polypoidal Choroidal Vasculopathy (IPCV)
The objectives of this study are to evaluate the safety and tolerability of Zimura™ intravitreous injection in combination with anti-vascular endothelial growth factor (VEGF) therapy in subjects with Idiopathic Polypoidal Choroidal Vasculopathy (IPCV).
Read the detailed description
Treatment experienced (Prior treatment with anti-VEGF monotherapy of ≥8 injections in the previous twelve (12) months) subjects of either gender aged 50 years or above with a diagnosis of IPCV, will receive 3 monthly (Q4W) intravitreal injections of Zimura™ (1 mg/eye) in combination with anti-VEGF therapy (Avastin® 1.25 mg/eye or Lucentis® 0.5 mg/eye or Eylea® 2 mg/eye).
Safety endpoints include visual acuity loss (proportion of subjects with >15 letter loss at Month 3), ophthalmic adverse events (AEs), systemic adverse events (AEs), change in total retinal thickness (SD-OCT) at Month 3, regression and/or elimination of polyps at Month 3 compared to screening as measured by indocyanine green angiography (ICGA), and laboratory values.
- Being tested
- Avacincaptad Pegol
- Keywords
- idiopathic polypoidal choroidal vasculopathy, IPCV, Zimura™ (previous name), Avastin®, Eylea®, Lucentis®
- 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.
Avacincaptad PegolDrug
Also called Zimura (previous name), IZERVAY, Avastin, Eylea
Subjects will receive monthly intravitreous injections of Avacincaptad Pegol in combination with Lucentis, Avastin or Eylea.
| Study group | Role | What they receive |
|---|---|---|
| Avacincaptad Pegol + Anti-VEGF | Experimental | Subjects will receive monthly intravitreous injections of Avacincaptad Pegol in combination with either Lucentis, Avastin or Eylea. Receives: Drug: Avacincaptad Pegol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With >15 ETDRS Letter Loss at Month 3
Number of participants with >15 ETDRS letter loss (with calculated percentage)
Measured: 3 Months
Number of Participants With Ophthalmic Adverse Events
Number of Participants with Ophthalmic Adverse Events (with calculated percentage)
Measured: 3 months
Number of Participants With Systemic Adverse Events
Number of Participants with Systemic Adverse Events (with calculated percentage)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study start12 Mar 2015
- Primary completion23 Oct 2015
- Study completion23 Oct 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 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
- NCT02397954
- Sponsor's protocol ID
- OPH2002
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2015
- Last updated
- 20 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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/.
Publications
Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.
PubMed 30957581
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Study to Establish the Safety and Tolerability of Zimura™ (Anti-C5 Aptamer) in Combination With Anti-VEGF Therapy in Subjects With Idiopathic Polypoidal Choroidal Vasculopathy (IPCV)
- ClinicalTrials.gov ID
- NCT02397954
- Acronym / sponsor ID
- OPH2002
- Keywords
- idiopathic polypoidal choroidal vasculopathy, IPCV, Zimura™ (previous name), Avastin®, Eylea®, Lucentis®
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Ophthotech CorporationIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2015 (actual)
- Primary completion
- 23 Oct 2015 (actual)
- Study completion
- 23 Oct 2015 (actual)
- First posted
- 25 Mar 2015 (estimated)
- Results
- Posted 23 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to evaluate the safety and tolerability of Zimura™ intravitreous injection in combination with anti-vascular endothelial growth factor (VEGF) therapy in subjects with Idiopathic Polypoidal Choroidal Vasculopathy (IPCV).
Detailed description
Treatment experienced (Prior treatment with anti-VEGF monotherapy of ≥8 injections in the previous twelve (12) months) subjects of either gender aged 50 years or above with a diagnosis of IPCV, will receive 3 monthly (Q4W) intravitreal injections of Zimura™ (1 mg/eye) in combination with anti-VEGF therapy (Avastin® 1.25 mg/eye or Lucentis® 0.5 mg/eye or Eylea® 2 mg/eye).
Safety endpoints include visual acuity loss (proportion of subjects with >15 letter loss at Month 3), ophthalmic adverse events (AEs), systemic adverse events (AEs), change in total retinal thickness (SD-OCT) at Month 3, regression and/or elimination of polyps at Month 3 compared to screening as measured by indocyanine green angiography (ICGA), and laboratory values.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avacincaptad Pegol + Anti-VEGF | Experimental | Drug: Avacincaptad PegolSubjects will receive monthly intravitreous injections of Avacincaptad Pegol in combination with either Lucentis, Avastin or Eylea. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects of either gender aged ≥ 50 years
- Diagnosis of IPCV
- Treatment-experienced defined as prior treatment with anti-VEGF mono therapy of ≥ 8 injections in the previous twelve (12) months
Key exclusion criteria (6 listed)
- Any intraocular surgery or thermal laser within three (3) months of trial entry
- Any prior thermal laser in the macular region, regardless of indication
- Any ocular or periocular infection in the twelve (12) weeks prior to entry
- History of any of the following conditions or procedures in the study eye: Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant
- Previous therapeutic radiation in the region of the study eye
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, Avastin, EyleaSubjects will receive monthly intravitreous injections of Avacincaptad Pegol in combination with Lucentis, Avastin or Eylea. | Drug | Avacincaptad Pegol + Anti-VEGF |
Primary outcome
Number of Participants With >15 ETDRS Letter Loss at Month 3
Time frame: 3 Months
Number of participants with >15 ETDRS letter loss (with calculated percentage)
Number of Participants With Ophthalmic Adverse Events
Time frame: 3 months
Number of Participants with Ophthalmic Adverse Events (with calculated percentage)
Number of Participants With Systemic Adverse Events
Time frame: 3 months
Number of Participants with Systemic 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 20 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30957581Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.
- Link to plain language summary of the study on the Trial Results Summaries 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/.
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 Avacincaptad Pegol 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 3 inclusion and 6 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 20 Mar 2025. 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?
Yes. Results are posted in the registry (first posted 23 Jan 2019). 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?
Number of Participants With >15 ETDRS Letter Loss at Month 3 (time frame: 3 Months). The study lists 3 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 NCT02397954, which also lists 1 linked publication.
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 20 Mar 2025.