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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02397954
Recruitment Status : Completed
First Posted : March 25, 2015
Results First Posted : January 23, 2019
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Ophthotech Corporation

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).

Condition or disease Intervention/treatment Phase
Idiopathic Polypoidal Choroidal Vasculopathy Drug: Zimura Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Zimura + Anti-VEGF
Subjects will receive monthly intravitreous injections of Zimura in combination with either Lucentis, Avastin or Eylea.
Drug: Zimura
Subjects will receive monthly intravitreous injections of Zimura in combination with Lucentis, Avastin or Eylea.
Other Names:
  • Avastin
  • Eylea
  • Lucentis




Primary Outcome Measures :
  1. Number of Participants With >15 ETDRS Letter Loss at Month 3 [ Time Frame: 3 Months ]
    Number of participants with >15 ETDRS letter loss (with calculated percentage)

  2. Number of Participants With Ophthalmic Adverse Events [ Time Frame: 3 months ]
    Number of Participants with Ophthalmic Adverse Events (with calculated percentage)

  3. Number of Participants With Systemic Adverse Events [ Time Frame: 3 months ]
    Number of Participants with Systemic Adverse Events (with calculated percentage)


Other Outcome Measures:
  1. Mean Change in Central Subfield Retinal Thickness (SD-OCT) From Baseline at Month 3 [ Time Frame: Baseline and Month 3 ]
    Mean change in central subfield retinal thickness from baseline at Month 3 as measured by SD-OCT

  2. Regression and/or Elimination of Polyps at Month 3 [ Time Frame: Baseline and Month 3 ]
    Regression and/or Elimination of Polyps from baseline to Month 3



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02397954


Locations
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United States, Arizona
Phoenix, Arizona, United States, 85014
Sponsors and Collaborators
Ophthotech Corporation

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Responsible Party: Ophthotech Corporation
ClinicalTrials.gov Identifier: NCT02397954     History of Changes
Other Study ID Numbers: OPH2002
First Posted: March 25, 2015    Key Record Dates
Results First Posted: January 23, 2019
Last Update Posted: June 19, 2019
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data at this time
Keywords provided by Ophthotech Corporation:
idiopathic polypoidal choroidal vasculopathy
IPCV
Zimura™
Avastin®
Eylea®
Lucentis®
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Bevacizumab
Ranibizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors