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
1 other identifier
interventional
64
3 countries
28
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2017
Shorter than P25 for phase_2
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 11, 2017
CompletedFirst Submitted
Initial submission to the registry
October 30, 2017
CompletedFirst Posted
Study publicly available on registry
December 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 18, 2018
CompletedResults Posted
Study results publicly available
February 2, 2022
CompletedJune 10, 2025
May 1, 2025
1 year
October 30, 2017
October 14, 2021
May 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Change From Baseline - ECG
6 months
Mean Change From Baseline - Study Eye ETDRS Visual Acuity
6 months
Mean Change From Baseline - Vital Signs
6 months
Study Arms (4)
Cohort 1
EXPERIMENTALAvacincaptad Pegol dosage 1 + Lucentis 0.5 mg
Cohort 2
EXPERIMENTALAvacincaptad Pegol dosage 2 + Lucentis 0.5 mg
Cohort 3
EXPERIMENTALAvacincaptad Pegol dosage 3 + Lucentis 0.5 mg
Cohort 4
EXPERIMENTALAvacincaptad Pegol dosage 4 + Lucentis 0.5 mg
Interventions
Avacincaptad Pegol in combination with Lucentis
Avacincaptad Pegol in combination with Lucentis
Eligibility Criteria
You may qualify if:
- Active subfoveal NVAMD
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Retinal Research Institute
Phoenix, Arizona, 85053, United States
Retina Centers PC
Tucson, Arizona, 85704, United States
Retina Associates SW, PC
Tucson, Arizona, 85710, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211, United States
Retina Consultants of Orange County
Fullerton, California, 92835, United States
Retina Consultants of Southern California
Redlands, California, 92374, United States
Retinal Consultants Medical Group
Sacramento, California, 95841, United States
Orange County Retina Medical Group
Santa Ana, California, 92705, United States
Colorado Retina Associates
Golden, Colorado, 80214, United States
Florida Eye Clinic
Altamonte Springs, Florida, 32701, United States
Florida Eye Associates
Melbourne, Florida, 32901, United States
Illinois Eye Center
Peoria, Illinois, 61615, United States
Vitreo Retinal Consultants & Surgeons
Wichita, Kansas, 67214, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
VitreoRetinal Surgery
Minneapolis, Minnesota, 55435, United States
Retina Consultants of Nevada
Henderson, Nevada, 89052, United States
Sierra Eye Associates
Reno, Nevada, 89502, United States
Retina Vitreous Surgeons of CNY, PC
Syracuse, New York, 13224, United States
Retina Northwest PC
Portland, Oregon, 97221, United States
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107, United States
Charleston Neuroscience Institute
Ladson, South Carolina, 29456, United States
Retina Research Institute of Texas
Abilene, Texas, 79606, United States
Strategic Clinical Research Group
Willow Park, Texas, 76087, United States
Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont
Budapest, 1076, Hungary
Budapest Retina Associates
Budapest, 1133, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szemeszeti Klinika
Szeged, 6702, Hungary
Pauls Stradins Clinical University Hospital, Clinic of Ophthalmology
Riga, LV-1002, Latvia
Dr. Solomatin's eye rehabilitation and vision correction centre
Riga, LV-1050, Latvia
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Hersh Patel, OD / Zimura Medical Director
- Organization
- IVERIC bio, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2017
First Posted
December 5, 2017
Study Start
October 11, 2017
Primary Completion
October 18, 2018
Study Completion
October 18, 2018
Last Updated
June 10, 2025
Results First Posted
February 2, 2022
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.