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Zimura in Participants With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

Primary Purpose

Geographic Atrophy, Macular Degeneration

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Zimura
Sham
Sponsored by
IVERIC bio, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Geographic Atrophy focused on measuring Geographic Atrophy (GA), Dry age-related macular degeneration, AMD, Zimura, Anti-inflammatory, complement factor C5 inhibitor, ARC1905, avacincaptad pegol

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects of either gender aged ≥ 50 years
  • Diagnosis of Non-foveal GA secondary to dry AMD

Exclusion Criteria:

  • 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

Sites / Locations

  • Retina Consultants of Hawaii
  • Clinical hospital center Osijek
  • Fakultni Nemocnice Brno
  • Faculty Hospital Hradec Kralove
  • Fakultni nemocnice Olomouc
  • Axon Clinical SRO
  • East Tallinn Central Hospital
  • Dr.Kai Noor Eye Clinic
  • Peterfy Korhaz-Rendelointezet Orszagos Traumatologiai Intezet
  • Rambam Medical Center
  • Hadassah University Hospital
  • Meir Medical Center
  • Rabin Medical Center
  • Kaplan Medical Center
  • Tel-Aviv Sourasky Medical Center
  • Pauls Stradins Clinical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Sham Comparator

Experimental

Experimental

Sham Comparator

Arm Label

Zimura 1 mg [Part 1]

Zimura 2 mg [Part 1]

Sham [Part 1]

Zimura 2 mg (Zimura 2mg+Sham) [Part 2]

Zimura 4 mg (Zimura 2mg+Zimura 2mg) [Part 2]

Sham (Sham+Sham) [Part 2]

Arm Description

Participants received 1 mg of Zimura in the study eye administered via IVT injection (50 µL) on Day 1 and monthly up to 18 months.

Participants received 2 mg of Zimura in the study eye administered via IVT injection (100 µL) on Day 1 and monthly up to 18 months.

Participants received a Sham injection of an empty, needleless syringe administered in the study eye on Day 1 and monthly up to 18 months.

Participants received 2 mg of Zimura in the study eye administered via IVT injection (100 µL) and a subsequent Sham administration on Day 1 and monthly up to 18 months.

Participants received 4 mg of Zimura in the study eye administered via two consecutive IVT injections (2 x 100 µL) on Day 1 and monthly up to 18 months.

Participants received two consecutive Sham injections of empty, needleless syringes administered in the study eye on Day 1 and monthly up to 18 months.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change From Baseline in Best Corrected Visual Acuity Using Early Treatment Diabetic Retinopathy Study Letters
The least squares mean change in best-corrected visual acuity (BCVA) from baseline to Month 12 was measured using early treatment diabetic retinopathy study [ETDRS] letters. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for the secondary endpoints; the Zimura 1 mg group was for descriptive purposes only.
Change From Baseline in Low Luminance BCVA Using Early Treatment Diabetic Retinopathy Study Letters
The least squares mean change in low luminance (LL) BCVA from baseline to Month 12 was measured using ETDRS letters. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for the secondary endpoints; the Zimura 1 mg group was for descriptive purposes only.

Full Information

First Posted
February 16, 2016
Last Updated
April 18, 2023
Sponsor
IVERIC bio, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02686658
Brief Title
Zimura in Participants With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
Official Title
A Phase 2/3 Randomized, Double-Masked, Controlled Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura™ (Anti-C5 Aptamer) in Subjects With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 20, 2016 (Actual)
Primary Completion Date
September 26, 2019 (Actual)
Study Completion Date
April 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IVERIC bio, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
Detailed Description
Participants will receive monthly intravitreal injections of Zimura or Sham for 18 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Geographic Atrophy, Macular Degeneration
Keywords
Geographic Atrophy (GA), Dry age-related macular degeneration, AMD, Zimura, Anti-inflammatory, complement factor C5 inhibitor, ARC1905, avacincaptad pegol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
The Reading Center team and Sponsor were also masked.
Allocation
Randomized
Enrollment
286 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zimura 1 mg [Part 1]
Arm Type
Experimental
Arm Description
Participants received 1 mg of Zimura in the study eye administered via IVT injection (50 µL) on Day 1 and monthly up to 18 months.
Arm Title
Zimura 2 mg [Part 1]
Arm Type
Experimental
Arm Description
Participants received 2 mg of Zimura in the study eye administered via IVT injection (100 µL) on Day 1 and monthly up to 18 months.
Arm Title
Sham [Part 1]
Arm Type
Sham Comparator
Arm Description
Participants received a Sham injection of an empty, needleless syringe administered in the study eye on Day 1 and monthly up to 18 months.
Arm Title
Zimura 2 mg (Zimura 2mg+Sham) [Part 2]
Arm Type
Experimental
Arm Description
Participants received 2 mg of Zimura in the study eye administered via IVT injection (100 µL) and a subsequent Sham administration on Day 1 and monthly up to 18 months.
Arm Title
Zimura 4 mg (Zimura 2mg+Zimura 2mg) [Part 2]
Arm Type
Experimental
Arm Description
Participants received 4 mg of Zimura in the study eye administered via two consecutive IVT injections (2 x 100 µL) on Day 1 and monthly up to 18 months.
Arm Title
Sham (Sham+Sham) [Part 2]
Arm Type
Sham Comparator
Arm Description
Participants received two consecutive Sham injections of empty, needleless syringes administered in the study eye on Day 1 and monthly up to 18 months.
Intervention Type
Drug
Intervention Name(s)
Zimura
Other Intervention Name(s)
avacincaptad pegol
Intervention Description
Zimura 20 mg/mL solution for intravitreal (IVT) injection
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Geographic Atrophy as Measured by Fundus Autofluorescence
Description
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.
Time Frame
Baseline and 12 months
Secondary Outcome Measure Information:
Title
Change From Baseline in Best Corrected Visual Acuity Using Early Treatment Diabetic Retinopathy Study Letters
Description
The least squares mean change in best-corrected visual acuity (BCVA) from baseline to Month 12 was measured using early treatment diabetic retinopathy study [ETDRS] letters. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for the secondary endpoints; the Zimura 1 mg group was for descriptive purposes only.
Time Frame
Baseline and 12 months
Title
Change From Baseline in Low Luminance BCVA Using Early Treatment Diabetic Retinopathy Study Letters
Description
The least squares mean change in low luminance (LL) BCVA from baseline to Month 12 was measured using ETDRS letters. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for the secondary endpoints; the Zimura 1 mg group was for descriptive purposes only.
Time Frame
Baseline and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants of either gender aged ≥ 50 years Diagnosis of Non-foveal GA secondary to dry AMD Exclusion Criteria: 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
Facility Information:
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
City
Campbell
State/Province
California
ZIP/Postal Code
95008
Country
United States
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95841
Country
United States
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33711
Country
United States
City
Stuart
State/Province
Florida
ZIP/Postal Code
34994
Country
United States
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Retina Consultants of Hawaii
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21209
Country
United States
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
City
Syracuse
State/Province
New York
ZIP/Postal Code
13224
Country
United States
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44136
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97221
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
City
West Mifflin
State/Province
Pennsylvania
ZIP/Postal Code
15122
Country
United States
City
Ladson
State/Province
South Carolina
ZIP/Postal Code
29456
Country
United States
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
City
Grapevine
State/Province
Texas
ZIP/Postal Code
76051
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
City
Willow Park
State/Province
Texas
ZIP/Postal Code
76087
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Clinical hospital center Osijek
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
Fakultni Nemocnice Brno
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Facility Name
Faculty Hospital Hradec Kralove
City
Hradec Králové
ZIP/Postal Code
50005
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia
Facility Name
Axon Clinical SRO
City
Praha
ZIP/Postal Code
15000
Country
Czechia
Facility Name
East Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
Dr.Kai Noor Eye Clinic
City
Tallinn
ZIP/Postal Code
11412
Country
Estonia
Facility Name
Peterfy Korhaz-Rendelointezet Orszagos Traumatologiai Intezet
City
Budapest
ZIP/Postal Code
1076
Country
Hungary
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
City
Budapest
ZIP/Postal Code
1133
Country
Hungary
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
City
Pecs
ZIP/Postal Code
7621
Country
Hungary
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
City
Veszprém
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Hadassah University Hospital
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Rabin Medical Center
City
Petah tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Kaplan Medical Center
City
Reẖovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Pauls Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
LV1002
Country
Latvia

12. IPD Sharing Statement

Citations:
PubMed Identifier
32882310
Citation
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.
Results Reference
result

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Zimura in Participants With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

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