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ZIMURA in Combination With LUCENTIS in Patients With Neovascular Age Related Macular Degeneration (NVAMD)

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: NCT03362190
Recruitment Status : Completed
First Posted : December 5, 2017
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Ophthotech ( Ophthotech Corporation )

Study Description
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Brief Summary:
To assess the safety of intravitreal Zimura™ (complement factor C5 inhibitor) administered in combination with Lucentis® 0.5 mg in treatment naïve subjects with neovascular age related macular degeneration (NVAMD)

Condition or disease Intervention/treatment Phase
Wet Age-related Macular Degeneration Drug: Zimura Drug: Lucentis Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2A Open-label Trial to Assess the Safety of ZIMURA™ (Anti-C5) Administered in Combination With LUCENTIS® 0.5 mg in Treatment Naive Subjects With Neovascular Age Related Macular Degeneration
Actual Study Start Date : October 11, 2017
Actual Primary Completion Date : October 18, 2018
Actual Study Completion Date : October 18, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1
Zimura dosage 1 + Lucentis 0.5 mg
 Drug: Zimura
Zimura in combination with Lucentis
Other Name: avacincaptad pegol

Drug: Lucentis
Zimura in combination with Lucentis
Other Name: ranibizumab
Experimental: Cohort 2
Zimura dosage 2 + Lucentis 0.5 mg
 Drug: Zimura
Zimura in combination with Lucentis
Other Name: avacincaptad pegol

Drug: Lucentis
Zimura in combination with Lucentis
Other Name: ranibizumab
Experimental: Cohort 3
Zimura dosage 3 + Lucentis 0.5 mg
 Drug: Zimura
Zimura in combination with Lucentis
Other Name: avacincaptad pegol

Drug: Lucentis
Zimura in combination with Lucentis
Other Name: ranibizumab
Experimental: Cohort 4
Zimura dosage 4 + Lucentis 0.5 mg
 Drug: Zimura
Zimura in combination with Lucentis
Other Name: avacincaptad pegol

Drug: Lucentis
Zimura in combination with Lucentis
Other Name: ranibizumab


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events (AEs) [ Time Frame: 6 months ]
    AEs


Eligibility Criteria
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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:

  • Active subfoveal NVAMD

Exclusion Criteria:

  • History or evidence of severe cardiac disease
  • Any major surgical procedure within one month of trial entry
  • Subjects with a clinically significant laboratory value
  • Any treatment with an investigational agent in the past 60 days for any condition
  • Women who are pregnant or nursing
  • Known serious allergies to the fluorescein dye used in angiography, povidone iodine, to the components of the ranibizumab formulation, or to the components of the Zimura formulation
  • Any prior treatment for AMD other than oral supplements of vitamins and minerals
Contacts and Locations
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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): NCT03362190


Locations
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Sponsors and Collaborators
Ophthotech Corporation
More Information
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Responsible Party: Ophthotech Corporation
ClinicalTrials.gov Identifier: NCT03362190    
Other Study ID Numbers: OPH2007
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: April 2018
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ophthotech ( Ophthotech Corporation ):
Zimura
ARC1905
Lucentis
ranibizumab
 Wet AMD
avacincaptad pegol
complement factor C5 inhibitor
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Angiogenesis Inhibitors
 Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents