Idiopathic Polypoidal Choroidal Vasculopathy
Conditions
Keywords
idiopathic polypoidal choroidal vasculopathy, IPCV, Zimura™ (previous name), Avastin®, Eylea®, Lucentis®
Brief 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).
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.
Interventions
Subjects will receive monthly intravitreous injections of Avacincaptad Pegol in combination with Lucentis, Avastin or Eylea.
Sponsors
Ophthotech Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With >15 ETDRS Letter Loss at Month 3 | 3 Months | Number of participants with \>15 ETDRS letter loss (with calculated percentage) |
| Number of Participants With Ophthalmic Adverse Events | 3 months | Number of Participants with Ophthalmic Adverse Events (with calculated percentage) |
| Number of Participants With Systemic Adverse Events | 3 months | Number of Participants with Systemic Adverse Events (with calculated percentage) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Central Subfield Retinal Thickness (SD-OCT) From Baseline at Month 3 | Baseline and Month 3 | Mean change in central subfield retinal thickness from baseline at Month 3 as measured by SD-OCT |
| Regression and/or Elimination of Polyps at Month 3 | Baseline and Month 3 | Regression and/or Elimination of Polyps from baseline to Month 3 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | Zimura + Anti-VEGF |
|---|---|
| Age, Continuous | 74.5 years STANDARD_DEVIATION 6.03 |
| Age, Customized Age Adults 50-65 | 0 Participants |
| Age, Customized Age Adults >65-75 | 2 Participants |
| Age, Customized Age Adults >75 | 2 Participants |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 3 / 4 |
| serious Total, serious adverse events | 1 / 4 |
Outcome results
Primary
Number of Participants With >15 ETDRS Letter Loss at Month 3
Number of participants with \>15 ETDRS letter loss (with calculated percentage)
Time frame: 3 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zimura + Anti-VEGF | Number of Participants With >15 ETDRS Letter Loss at Month 3 | 0 Participants |
Primary
Number of Participants With Ophthalmic Adverse Events
Number of Participants with Ophthalmic Adverse Events (with calculated percentage)
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zimura + Anti-VEGF | Number of Participants With Ophthalmic Adverse Events | 3 Participants |
Primary
Number of Participants With Systemic Adverse Events
Number of Participants with Systemic Adverse Events (with calculated percentage)
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zimura + Anti-VEGF | Number of Participants With Systemic Adverse Events | 1 Participants |
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
Time frame: Baseline and Month 3
Population: Limited sample size; all study participants were included in the analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Zimura + Anti-VEGF | Mean Change in Central Subfield Retinal Thickness (SD-OCT) From Baseline at Month 3 | -2.75 μm |
Other Pre-specified
Regression and/or Elimination of Polyps at Month 3
Regression and/or Elimination of Polyps from baseline to Month 3
Time frame: Baseline and Month 3
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zimura + Anti-VEGF | Regression and/or Elimination of Polyps at Month 3 | NA Polyps |