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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
Results First Posted : February 2, 2022
Last Update Posted : February 9, 2022
Sponsor:
Information provided by (Responsible Party):
IVERIC bio, Inc. ( 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 : 64 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. Systemic Adverse Events [ Time Frame: 6 months ]
    Number of Participants with systemic treatment-emergent Adverse Events (with calculated percentage)

  2. Ophthalmic Adverse Events [ Time Frame: 6 months ]
    Number of participants with ophthalmic Adverse Events (with calculated percentage)


Other Outcome Measures:
  1. Change From Baseline - ECG [ Time Frame: 6 months ]
    Number of patients with a change on their Month 6 ECG when compared to their baseline ECG

  2. Mean Change From Baseline - Study Eye ETDRS Visual Acuity [ Time Frame: 6 months ]
    Mean change from Baseline to Month 6 in the number of letters read by the study eye using the ETDRS Visual Acuity charts. Higher ETDRS letters represents better vision and a larger change in ETDRS letters represents better functioning.

  3. Mean Change From Baseline - Vital Signs [ Time Frame: 6 months ]
    Mean change from Baseline to Month 6 in blood pressure (mm Hg). A negative number indicates a decrease and a positive number indicates an increase.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Show Show 28 study locations
Sponsors and Collaborators
Ophthotech Corporation
  Study Documents (Full-Text)

Documents provided by IVERIC bio, Inc. ( Ophthotech Corporation ):
Study Protocol  [PDF] August 9, 2017
Statistical Analysis Plan  [PDF] September 25, 2018

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
Results First Posted: February 2, 2022
Last Update Posted: February 9, 2022
Last Verified: February 2022
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 IVERIC bio, Inc. ( 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