Clinical trial NCT02397954: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Idiopathic Polypoidal Choroidal Vasculopathy
Keywords: idiopathic polypoidal choroidal vasculopathy
IPCV
Zimura™ (previous name)
Avastin®
Eylea®
Lucentis®
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2015-03-25
Enrollment: 4
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Number of Participants With >15 ETDRS Letter Loss at Month 3
timeFrame: 3 Months
measure: Number of Participants With Ophthalmic Adverse Events
timeFrame: 3 months
measure: Number of Participants With Systemic Adverse Events
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
measure: Mean Change in Central Subfield Retinal Thickness (SD-OCT) From Baseline at Month 3
timeFrame: Baseline and Month 3
measure: Regression and/or Elimination of Polyps at Month 3
timeFrame: Baseline and Month 3
Locations:
city: Phoenix
country: United States
state: Arizona
Study officials:
References:
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.