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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 : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Ophthotech Corporation

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 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

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



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



Information from the National Library of Medicine

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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

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

Locations
United States, Arizona
Retinal Research Institute Recruiting
Phoenix, Arizona, United States, 85053
Retina Centers PC Recruiting
Tucson, Arizona, United States, 85704
Retina Associates SW, PC Recruiting
Tucson, Arizona, United States, 85710
United States, California
Retina-Vitreous Associates Medical Group Recruiting
Beverly Hills, California, United States, 90211
Retina Consultants of Orange County Recruiting
Fullerton, California, United States, 92835
Retina Consultants of Southern California Recruiting
Redlands, California, United States, 92374
Retinal Consultants Medical Group Recruiting
Sacramento, California, United States, 95841
Orange County Retina Medical Group Recruiting
Santa Ana, California, United States, 92705
United States, Colorado
Colorado Retina Associates Recruiting
Golden, Colorado, United States, 80214
United States, Florida
Florida Eye Clinic Recruiting
Altamonte Springs, Florida, United States, 32701
Florida Eye Associates Recruiting
Melbourne, Florida, United States, 32901
United States, Illinois
Illinois Eye Center Recruiting
Peoria, Illinois, United States, 61615
United States, Kansas
Vitreo Retinal Consultants & Surgeons Recruiting
Wichita, Kansas, United States, 67214
United States, Massachusetts
Ophthalmic Consultants of Boston Recruiting
Boston, Massachusetts, United States, 02114
United States, Minnesota
VitreoRetinal Surgery Recruiting
Minneapolis, Minnesota, United States, 55435
United States, Nevada
Retina Consultants of Nevada Recruiting
Henderson, Nevada, United States, 89052
Sierra Eye Associates Recruiting
Reno, Nevada, United States, 89502
United States, New York
Retina Vitreous Surgeons of CNY, PC Recruiting
Syracuse, New York, United States, 13224
United States, Oregon
Retina Northwest PC Recruiting
Portland, Oregon, United States, 97221
United States, South Carolina
Charleston Neuroscience Institute Recruiting
Ladson, South Carolina, United States, 29456
United States, Texas
Retina Research Institute of Texas Recruiting
Abilene, Texas, United States, 79606
Strategic Clinical Research Group Recruiting
Willow Park, Texas, United States, 76087
Sponsors and Collaborators
Ophthotech Corporation

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: January 23, 2018
Last Verified: January 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