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

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

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)

Study Overview

• Status: Completed
• Conditions: Wet Age-related Macular Degeneration
• Intervention / Treatment: Drug: Zimura; Drug: Lucentis

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 2

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1076
    • Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont
  • Budapest, Hungary, 1133
    • Budapest Retina Associates
  • Szeged, Hungary, 6702
    • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szemeszeti Klinika
• Latvia
  • Riga, Latvia, LV-1002
    • Pauls Stradins Clinical University Hospital, Clinic of Ophthalmology
  • Riga, Latvia, LV-1050
    • Dr. Solomatin's eye rehabilitation and vision correction centre
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85053
      • Retinal Research Institute
    • Tucson, Arizona, United States, 85704
      • Retina Centers PC
    • Tucson, Arizona, United States, 85710
      • Retina Associates SW, PC
  • California
    • Beverly Hills, California, United States, 90211
      • Retina-Vitreous Associates Medical Group
    • Fullerton, California, United States, 92835
      • Retina Consultants of Orange County
    • Redlands, California, United States, 92374
      • Retina Consultants of Southern California
    • Sacramento, California, United States, 95841
      • Retinal Consultants Medical Group
    • Santa Ana, California, United States, 92705
      • Orange County Retina Medical Group
  • Colorado
    • Golden, Colorado, United States, 80214
      • Colorado Retina Associates
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • Florida Eye Clinic
    • Melbourne, Florida, United States, 32901
      • Florida Eye Associates
  • Illinois
    • Peoria, Illinois, United States, 61615
      • Illinois Eye Center
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Vitreo Retinal Consultants & Surgeons
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Ophthalmic Consultants of Boston
  • Minnesota
    • Minneapolis, Minnesota, United States, 55435
      • VitreoRetinal Surgery
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Retina Consultants of Nevada
    • Reno, Nevada, United States, 89502
      • Sierra Eye Associates
  • New York
    • Syracuse, New York, United States, 13224
      • Retina Vitreous Surgeons of CNY, PC
  • Oregon
    • Portland, Oregon, United States, 97221
      • Retina Northwest PC
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Mid Atlantic Retina
  • South Carolina
    • Ladson, South Carolina, United States, 29456
      • Charleston Neuroscience Institute
  • Texas
    • Abilene, Texas, United States, 79606
      • Retina Research Institute of Texas
    • Willow Park, Texas, United States, 76087
      • Strategic Clinical Research Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Zimura dosage 1 + Lucentis 0.5 mg	Drug: Zimura; Zimura in combination with Lucentis; Other Names: avacincaptad pegol; Drug: Lucentis; Zimura in combination with Lucentis; Other Names: ranibizumab
Experimental: Cohort 2; Zimura dosage 2 + Lucentis 0.5 mg	Drug: Zimura; Zimura in combination with Lucentis; Other Names: avacincaptad pegol; Drug: Lucentis; Zimura in combination with Lucentis; Other Names: ranibizumab
Experimental: Cohort 3; Zimura dosage 3 + Lucentis 0.5 mg	Drug: Zimura; Zimura in combination with Lucentis; Other Names: avacincaptad pegol; Drug: Lucentis; Zimura in combination with Lucentis; Other Names: ranibizumab
Experimental: Cohort 4; Zimura dosage 4 + Lucentis 0.5 mg	Drug: Zimura; Zimura in combination with Lucentis; Other Names: avacincaptad pegol; Drug: Lucentis; Zimura in combination with Lucentis; Other Names: ranibizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systemic Adverse Events	Number of Participants with systemic treatment-emergent Adverse Events (with calculated percentage)	6 months
Ophthalmic Adverse Events	Number of participants with ophthalmic Adverse Events (with calculated percentage)	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline - ECG	Number of patients with a change on their Month 6 ECG when compared to their baseline ECG	6 months
Mean Change From Baseline - Study Eye ETDRS Visual Acuity	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.	6 months
Mean Change From Baseline - Vital Signs	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.	6 months

Collaborators and Investigators

• Sponsor: Ophthotech Corporation

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2017
• Primary Completion (Actual): October 18, 2018
• Study Completion (Actual): October 18, 2018

Study Registration Dates

• First Submitted: October 30, 2017
• First Submitted That Met QC Criteria: November 29, 2017
• First Posted (Actual): December 5, 2017

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Lucentis; Wet AMD; ranibizumab; Zimura; ARC1905; avacincaptad pegol; complement factor C5 inhibitor
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab
• Other Study ID Numbers: OPH2007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No