Zimura in Participants With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
A Phase 2/3 Randomized, Double-Masked, Controlled Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura™ (Anti-C5 Aptamer) in Patients With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
2 other identifiers
interventional
286
7 countries
78
Brief Summary
The objectives of this study were to evaluate the safety and efficacy of Zimura intravitreal (IVT) administration when administered in participants with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2015
Typical duration for phase_2
78 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
December 15, 2015
CompletedFirst Submitted
Initial submission to the registry
February 16, 2016
CompletedFirst Posted
Study publicly available on registry
February 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 23, 2020
CompletedResults Posted
Study results publicly available
May 11, 2023
CompletedJune 10, 2025
May 1, 2025
3.8 years
February 16, 2016
January 27, 2023
May 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Geographic Atrophy as Measured by Fundus Autofluorescence
The least squares mean change in geographic atrophy (GA) from baseline to Month 12 was measured by fundus autofluorescence (FAF). The square root of the GA area was used in the analysis. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for this primary endpoint; the Zimura 1 mg group was for descriptive purposes only.
Baseline and 12 months
Secondary Outcomes (2)
Change From Baseline in Best Corrected Visual Acuity Using Early Treatment Diabetic Retinopathy Study Letters
Baseline and 12 months
Change From Baseline in Low Luminance BCVA Using Early Treatment Diabetic Retinopathy Study Letters
Baseline and 12 months
Study Arms (6)
Avacincaptad Pegol 1 mg [Part 1]
EXPERIMENTALParticipants 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 2 mg [Part 1]
EXPERIMENTALParticipants 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.
Sham [Part 1]
SHAM COMPARATORParticipants received a Sham injection of an empty, needleless syringe administered in the study eye on Day 1 and monthly up to 18 months.
Avacincaptad Pegol 2 mg (Avacincaptad Pegol 2mg+Sham) [Part 2]
EXPERIMENTALParticipants 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 4 mg (Avacincaptad Pegol 2mg+Avacincaptad Pegol 2mg) [Part 2]
EXPERIMENTALParticipants 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.
Sham (Sham+Sham) [Part 2]
SHAM COMPARATORParticipants received two consecutive Sham injections of empty, needleless syringes administered in the study eye on Day 1 and monthly up to 18 months.
Interventions
Avacincaptad Pegol 20 mg/mL solution for intravitreal (IVT) injection
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.
Eligibility Criteria
You may qualify if:
- Participants of either gender aged ≥ 50 years
- Diagnosis of Non-foveal GA secondary to dry AMD
You may not qualify if:
- Evidence of Choroidal Neovascularization (CNV)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- IVERIC bio, Inc.lead
Study Sites (78)
Unknown Facility
Phoenix, Arizona, 85053, United States
Unknown Facility
Tucson, Arizona, 85704, United States
Unknown Facility
Tucson, Arizona, 85710, United States
Unknown Facility
Campbell, California, 95008, United States
Unknown Facility
Fresno, California, 93720, United States
Unknown Facility
Fullerton, California, 92835, United States
Unknown Facility
La Jolla, California, 92093, United States
Unknown Facility
Mountain View, California, 94040, United States
Unknown Facility
Redlands, California, 92374, United States
Unknown Facility
Sacramento, California, 95819, United States
Unknown Facility
Sacramento, California, 95841, United States
Unknown Facility
Santa Ana, California, 92705, United States
Unknown Facility
Denver, Colorado, 80210, United States
Unknown Facility
Altamonte Springs, Florida, 32701, United States
Unknown Facility
Boynton Beach, Florida, 33426, United States
Unknown Facility
Melbourne, Florida, 32901, United States
Unknown Facility
St. Petersburg, Florida, 33711, United States
Unknown Facility
Stuart, Florida, 34994, United States
Unknown Facility
Winter Haven, Florida, 33880, United States
Unknown Facility
Augusta, Georgia, 30909, United States
Unknown Facility
Marietta, Georgia, 30060, United States
Retina Consultants of Hawaii
‘Aiea, Hawaii, 96701, United States
Unknown Facility
West Des Moines, Iowa, 50266, United States
Unknown Facility
Shawnee Mission, Kansas, 66204, United States
Unknown Facility
Wichita, Kansas, 67214, United States
Unknown Facility
Baltimore, Maryland, 21209, United States
Unknown Facility
Chevy Chase, Maryland, 20815, United States
Unknown Facility
Boston, Massachusetts, 02114, United States
Unknown Facility
Springfield, Massachusetts, 01107, United States
Unknown Facility
Grand Rapids, Michigan, 49546, United States
Unknown Facility
Henderson, Nevada, 89052, United States
Unknown Facility
Reno, Nevada, 89502, United States
Unknown Facility
Rochester, New York, 14620, United States
Unknown Facility
Syracuse, New York, 13224, United States
Unknown Facility
Asheville, North Carolina, 28803, United States
Unknown Facility
Charlotte, North Carolina, 28210, United States
Unknown Facility
Hickory, North Carolina, 28602, United States
Unknown Facility
Cincinnati, Ohio, 45242, United States
Unknown Facility
Cleveland, Ohio, 44130, United States
Unknown Facility
Cleveland, Ohio, 44136, United States
Unknown Facility
Portland, Oregon, 97221, United States
Unknown Facility
Philadelphia, Pennsylvania, 19107, United States
Unknown Facility
West Mifflin, Pennsylvania, 15122, United States
Unknown Facility
Ladson, South Carolina, 29456, United States
Unknown Facility
West Columbia, South Carolina, 29169, United States
Unknown Facility
Abilene, Texas, 79606, United States
Unknown Facility
Amarillo, Texas, 79106, United States
Unknown Facility
Austin, Texas, 78705, United States
Unknown Facility
Grapevine, Texas, 76051, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
The Woodlands, Texas, 77384, United States
Unknown Facility
Willow Park, Texas, 76087, United States
Unknown Facility
Salt Lake City, Utah, 84107, United States
Unknown Facility
Salt Lake City, Utah, 84132, United States
Unknown Facility
Richmond, Virginia, 23235, United States
Clinical hospital center Osijek
Osijek, 31000, Croatia
Fakultni Nemocnice Brno
Brno, 62500, Czechia
Faculty Hospital Hradec Kralove
Hradec Králové, 50005, Czechia
Fakultni nemocnice Olomouc
Olomouc, 77900, Czechia
Axon Clinical SRO
Prague, 15000, Czechia
East Tallinn Central Hospital
Tallinn, 10138, Estonia
Dr.Kai Noor Eye Clinic
Tallinn, 11412, Estonia
Peterfy Korhaz-Rendelointezet Orszagos Traumatologiai Intezet
Budapest, 1076, Hungary
Unknown Facility
Budapest, 1083, Hungary
Unknown Facility
Budapest, 1106, Hungary
Unknown Facility
Budapest, 1133, Hungary
Unknown Facility
Budapest, 1145, Hungary
Unknown Facility
Debrecen, 4012, Hungary
Unknown Facility
Pécs, 7621, Hungary
Unknown Facility
Szeged, 6720, Hungary
Unknown Facility
Veszprém, 8200, Hungary
Rambam Medical Center
Haifa, 3109601, Israel
Hadassah University Hospital
Jerusalem, 91120, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
Kaplan Medical Center
Rehovot, 76100, Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
Pauls Stradins Clinical University Hospital
Riga, LV1002, Latvia
Related Publications (3)
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.
PMID: 32882310RESULTCorradetti 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.
PMID: 39538001DERIVEDTzoumas 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.
PMID: 37314061DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- 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
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- The Reading Center team and Sponsor were also masked.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2016
First Posted
February 19, 2016
Study Start
December 15, 2015
Primary Completion
September 26, 2019
Study Completion
April 23, 2020
Last Updated
June 10, 2025
Results First Posted
May 11, 2023
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/.