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)

Idiopathic Polypoidal Choroidal Vasculopathy Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02397954
• Other study ID #: OPH2002
• Status: Completed
• Phase: Phase 2
• Start date: March 2015
• Est. completion date: October 2015

Study information

• Verified date: April 2017
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Idiopathic Polypoidal Choroidal Vasculopathy
• Polypoidal Choroidal Vasculopathy
• Vascular Diseases

Intervention

Drug:
• Zimura
Subjects will receive monthly intravitreous injections of Zimura in combination with Lucentis, Avastin or Eylea.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ophthotech Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Regression and/or Elimination of Polyps at Month 3	Regression and/or Elimination of Polyps from baseline to Month 3	Baseline and Month 3
Primary	Number of Participants With >15 ETDRS Letter Loss at Month 3	Number of participants with >15 ETDRS letter loss (with calculated percentage)	3 Months
Primary	Number of Participants With Ophthalmic Adverse Events	Number of Participants with Ophthalmic Adverse Events (with calculated percentage)	3 months
Primary	Number of Participants With Systemic Adverse Events	Number of Participants with Systemic Adverse Events (with calculated percentage)	3 months