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The objectives of this study are to evaluate the safety and tolerability of Zimuraâ„¢ intravitreous injection in combination with anti-vascular endothelial growth factor (VEGF) therapy in subjects with Idiopathic Polypoidal Choroidal Vasculopathy (IPCV).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avacincaptad Pegol + Anti-VEGF | Experimental | Subjects will receive monthly intravitreous injections of Avacincaptad Pegol in combination with either Lucentis, Avastin or Eylea. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avacincaptad Pegol | Drug | Subjects will receive monthly intravitreous injections of Avacincaptad Pegol in combination with Lucentis, Avastin or Eylea. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With >15 ETDRS Letter Loss at Month 3 | Number of participants with >15 ETDRS letter loss (with calculated percentage) | 3 Months |
| Number of Participants With Ophthalmic Adverse Events | Number of Participants with Ophthalmic Adverse Events (with calculated percentage) | 3 months |
| Number of Participants With Systemic Adverse Events | Number of Participants with Systemic Adverse Events (with calculated percentage) | 3 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Central Subfield Retinal Thickness (SD-OCT) From Baseline at Month 3 | Mean change in central subfield retinal thickness from baseline at Month 3 as measured by SD-OCT | Baseline and Month 3 |
| Regression and/or Elimination of Polyps at Month 3 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85014 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30957581 | Derived | 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. |
| Label | URL |
|---|---|
| Link to plain language summary of the study on the Trial Results Summaries website | View source |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Zimura + Anti-VEGF | Zimura 1mg/eye intravitreal injection + Anti-vascular endothelial growth factor (VEGF) (Avastin 1.25mg/eye or Lucentis 0.5mg/eye or Eylea 2mg/eye) intravitreal injection |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Regression and/or Elimination of Polyps from baseline to Month 3
| Baseline and Month 3 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Zimura + Anti-VEGF | Zimura 1mg/eye intravitreal injection + Anti-VEGF (Avastin 1.25mg/eye or Lucentis 0.5mg/eye or Eylea 2mg/eye) intravitreal injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With >15 ETDRS Letter Loss at Month 3 | Number of participants with >15 ETDRS letter loss (with calculated percentage) | Posted | Count of Participants | Participants | 3 Months |
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| Primary | Number of Participants With Ophthalmic Adverse Events | Number of Participants with Ophthalmic Adverse Events (with calculated percentage) | Posted | Count of Participants | Participants | 3 months |
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| Primary | Number of Participants With Systemic Adverse Events | Number of Participants with Systemic Adverse Events (with calculated percentage) | Posted | Count of Participants | Participants | 3 months |
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| Other Pre-specified | Mean Change in Central Subfield Retinal Thickness (SD-OCT) From Baseline at Month 3 | Mean change in central subfield retinal thickness from baseline at Month 3 as measured by SD-OCT | Limited sample size; all study participants were included in the analysis. | Posted | Mean | Full Range | μm | Baseline and Month 3 |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Regression and/or Elimination of Polyps at Month 3 | Regression and/or Elimination of Polyps from baseline to Month 3 | Posted | Number | Polyps | Baseline and Month 3 |
|
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3 Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zimura + Anti-VEGF | Zimura 1mg/eye intravitreal injection + Anti-VEGF (Avastin 1.25mg/eye or Lucentis 0.5mg/eye or Eylea 2mg/eye) intravitreal injection | 0 | 4 | 1 | 4 | 3 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Endophthalmitis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival haemorrhage | Eye disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
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Institution agrees not to individually publish the results of the Study without Ophthotech's prior written consent. Institution may participate in a joint, multi-center publication of the Study results with other investigators and/or institutions only, upon the prior written consent of Ophthotech.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keith Westby | Ophthotech Corp | Keith.Westby@ophthotech.com |
| ID | Term |
|---|---|
| D000092342 | Polypoidal Choroidal Vasculopathy |
| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| C533178 | aflibercept |
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| Adults >75 |
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