Zimura in Participants With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
NCT ID: NCT02686658
Last Updated: 2025-06-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
286 participants
INTERVENTIONAL
2015-12-15
2020-04-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)
NCT04435366
Safety Study of Zimura in Combination With Anti-VEGF Therapy in Patients With Neovascular AMD
NCT05571267
A Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration
NCT03525613
ZIMURA in Combination With LUCENTIS in Patients With Neovascular Age Related Macular Degeneration (NVAMD)
NCT03362190
First in Human Study to Evaluate the Safety and Tolerability of GEM103 in Geographic Atrophy Secondary to Dry Age Related Macular Degeneration
NCT04246866
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Avacincaptad Pegol 1 mg [Part 1]
Participants received 1 mg of Avacincaptad Pegol in the study eye administered via IVT injection (50 µL) on Day 1 and monthly up to 18 months.
Avacincaptad Pegol
Avacincaptad Pegol 20 mg/mL solution for intravitreal (IVT) injection
Avacincaptad Pegol 2 mg [Part 1]
Participants received 2 mg of Avacincaptad Pegol in the study eye administered via IVT injection (100 µL) on Day 1 and monthly up to 18 months.
Avacincaptad Pegol
Avacincaptad Pegol 20 mg/mL solution for intravitreal (IVT) injection
Sham [Part 1]
Participants received a Sham injection of an empty, needleless syringe administered in the study eye on Day 1 and monthly up to 18 months.
Sham
The Sham procedure included the blunt opening of an empty, needleless syringe barrel placed on the conjunctiva in the inferotemporal quadrant of the eyeball to simulate the pressure of an injection.
Avacincaptad Pegol 2 mg (Avacincaptad Pegol 2mg+Sham) [Part 2]
Participants received 2 mg of Avacincaptad Pegol in the study eye administered via IVT injection (100 µL) and a subsequent Sham administration on Day 1 and monthly up to 18 months.
Avacincaptad Pegol
Avacincaptad Pegol 20 mg/mL solution for intravitreal (IVT) injection
Sham
The Sham procedure included the blunt opening of an empty, needleless syringe barrel placed on the conjunctiva in the inferotemporal quadrant of the eyeball to simulate the pressure of an injection.
Avacincaptad Pegol 4 mg (Avacincaptad Pegol 2mg+Avacincaptad Pegol 2mg) [Part 2]
Participants received 4 mg of Avacincaptad Pegol in the study eye administered via two consecutive IVT injections (2 x 100 µL) on Day 1 and monthly up to 18 months.
Avacincaptad Pegol
Avacincaptad Pegol 20 mg/mL solution for intravitreal (IVT) injection
Sham (Sham+Sham) [Part 2]
Participants received two consecutive Sham injections of empty, needleless syringes administered in the study eye on Day 1 and monthly up to 18 months.
Sham
The Sham procedure included the blunt opening of an empty, needleless syringe barrel placed on the conjunctiva in the inferotemporal quadrant of the eyeball to simulate the pressure of an injection.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Avacincaptad Pegol
Avacincaptad Pegol 20 mg/mL solution for intravitreal (IVT) injection
Sham
The Sham procedure included the blunt opening of an empty, needleless syringe barrel placed on the conjunctiva in the inferotemporal quadrant of the eyeball to simulate the pressure of an injection.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of Non-foveal GA secondary to dry AMD
Exclusion Criteria
* GA secondary to any condition other than AMD
* Any prior treatment for AMD or any prior intravitreal treatment for any indication in either eye, except oral supplements of vitamins and minerals
* Any intraocular surgery or thermal laser within three (3) months of trial entry
* Any prior thermal laser in the macular region, regardless of indication
* Any ocular or periocular infection in the twelve (12) weeks
* Previous therapeutic radiation in the region of the study eye
* Any sign of diabetic retinopathy in either eye
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
IVERIC bio, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Phoenix, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Campbell, California, United States
Fresno, California, United States
Fullerton, California, United States
La Jolla, California, United States
Mountain View, California, United States
Redlands, California, United States
Sacramento, California, United States
Sacramento, California, United States
Santa Ana, California, United States
Denver, Colorado, United States
Altamonte Springs, Florida, United States
Boynton Beach, Florida, United States
Melbourne, Florida, United States
St. Petersburg, Florida, United States
Stuart, Florida, United States
Winter Haven, Florida, United States
Augusta, Georgia, United States
Marietta, Georgia, United States
Retina Consultants of Hawaii
‘Aiea, Hawaii, United States
West Des Moines, Iowa, United States
Shawnee Mission, Kansas, United States
Wichita, Kansas, United States
Baltimore, Maryland, United States
Chevy Chase, Maryland, United States
Boston, Massachusetts, United States
Springfield, Massachusetts, United States
Grand Rapids, Michigan, United States
Henderson, Nevada, United States
Reno, Nevada, United States
Rochester, New York, United States
Syracuse, New York, United States
Asheville, North Carolina, United States
Charlotte, North Carolina, United States
Hickory, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Cleveland, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
West Mifflin, Pennsylvania, United States
Ladson, South Carolina, United States
West Columbia, South Carolina, United States
Abilene, Texas, United States
Amarillo, Texas, United States
Austin, Texas, United States
Grapevine, Texas, United States
Houston, Texas, United States
The Woodlands, Texas, United States
Willow Park, Texas, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
Richmond, Virginia, United States
Clinical hospital center Osijek
Osijek, , Croatia
Fakultni Nemocnice Brno
Brno, , Czechia
Faculty Hospital Hradec Kralove
Hradec Králové, , Czechia
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Axon Clinical SRO
Prague, , Czechia
East Tallinn Central Hospital
Tallinn, , Estonia
Dr.Kai Noor Eye Clinic
Tallinn, , Estonia
Peterfy Korhaz-Rendelointezet Orszagos Traumatologiai Intezet
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Pécs, , Hungary
Szeged, , Hungary
Veszprém, , Hungary
Rambam Medical Center
Haifa, , Israel
Hadassah University Hospital
Jerusalem, , Israel
Meir Medical Center
Kfar Saba, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Kaplan Medical Center
Rehovot, , Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, , Israel
Pauls Stradins Clinical University Hospital
Riga, , Latvia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Jaffe GJ, Westby K, Csaky KG, Mones J, Pearlman JA, Patel SS, Joondeph BC, Randolph J, Masonson H, Rezaei KA. C5 Inhibitor Avacincaptad Pegol for Geographic Atrophy Due to Age-Related Macular Degeneration: A Randomized Pivotal Phase 2/3 Trial. Ophthalmology. 2021 Apr;128(4):576-586. doi: 10.1016/j.ophtha.2020.08.027. Epub 2020 Sep 1.
Corradetti G, Karamat A, Srinivas S, Lindenberg S, Velaga SB, Corvi F, Attiku Y, Nittala MG, Desai D, Zhu L, Abulon D, Sadda SR. Progression to complete retinal pigment epithelium and outer retinal atrophy (cRORA): post hoc analysis of the GATHER1 trial. Graefes Arch Clin Exp Ophthalmol. 2025 Mar;263(3):669-677. doi: 10.1007/s00417-024-06676-7. Epub 2024 Nov 14.
Tzoumas N, Riding G, Williams MA, Steel DH. Complement inhibitors for age-related macular degeneration. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD009300. doi: 10.1002/14651858.CD009300.pub3.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Link to plain language summary of the study on the Trial Results Summaries website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-003991-56
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
OPH2003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.