Back to resultsA 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)
Primary Purpose
Idiopathic Polypoidal Choroidal Vasculopathy
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Zimura
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Polypoidal Choroidal Vasculopathy focused on measuring idiopathic polypoidal choroidal vasculopathy, IPCV, Zimura™, Avastin®, Eylea®, Lucentis®
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Zimura + Anti-VEGF
Arm Description
Subjects will receive monthly intravitreous injections of Zimura in combination with either Lucentis, Avastin or Eylea.
Outcomes
Primary Outcome Measures
Number of Participants With >15 ETDRS Letter Loss at Month 3
Number of participants with >15 ETDRS letter loss (with calculated percentage)
Number of Participants With Ophthalmic Adverse Events
Number of Participants with Ophthalmic Adverse Events (with calculated percentage)
Number of Participants With Systemic Adverse Events
Number of Participants with Systemic Adverse Events (with calculated percentage)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02397954
Brief Title
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)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ophthotech Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Polypoidal Choroidal Vasculopathy
Keywords
idiopathic polypoidal choroidal vasculopathy, IPCV, Zimura™, Avastin®, Eylea®, Lucentis®
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zimura + Anti-VEGF
Arm Type
Experimental
Arm Description
Subjects will receive monthly intravitreous injections of Zimura in combination with either Lucentis, Avastin or Eylea.
Intervention Type
Drug
Intervention Name(s)
Zimura
Other Intervention Name(s)
Avastin, Eylea, Lucentis
Intervention Description
Subjects will receive monthly intravitreous injections of Zimura in combination with Lucentis, Avastin or Eylea.
Primary Outcome Measure Information:
Title
Number of Participants With >15 ETDRS Letter Loss at Month 3
Description
Number of participants with >15 ETDRS letter loss (with calculated percentage)
Time Frame
3 Months
Title
Number of Participants With Ophthalmic Adverse Events
Description
Number of Participants with Ophthalmic Adverse Events (with calculated percentage)
Time Frame
3 months
Title
Number of Participants With Systemic Adverse Events
Description
Number of Participants with Systemic Adverse Events (with calculated percentage)
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Mean Change in Central Subfield Retinal Thickness (SD-OCT) From Baseline at Month 3
Description
Mean change in central subfield retinal thickness from baseline at Month 3 as measured by SD-OCT
Time Frame
Baseline and Month 3
Title
Regression and/or Elimination of Polyps at Month 3
Description
Regression and/or Elimination of Polyps from baseline to Month 3
Time Frame
Baseline and Month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data at this time
Citations:
PubMed Identifier
30957581
Citation
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.
Results Reference
derived
Learn more about this trial
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)
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