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

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ClinicalTrials.gov Identifier: NCT03362190
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
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)
Estimated Enrollment : 60 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
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab
U.S. FDA Resources

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, Senior)
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


Contacts
Contact: Denise Teuber 646-753-8461 denise.teuber@ophthotech.com

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Sponsors and Collaborators
Ophthotech Corporation
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Ophthotech Corporation
ClinicalTrials.gov Identifier: NCT03362190     History of Changes
Other Study ID Numbers: OPH2007
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ophthotech Corporation:
Zimura
ARC1905
Lucentis
ranibizumab
 Wet AMD
avacincaptad pegol
complement factor C5 inhibitor

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Immunologic Factors
 Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents