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

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ClinicalTrials.gov Identifier: NCT02686658
Recruitment Status : Active, not recruiting
First Posted : February 19, 2016
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
Ophthotech Corporation

Brief Summary:
The objectives of this study are to evaluate the safety and efficacy of intravitreous administration of Zimura when administered in subjects with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).

Condition or disease Intervention/treatment Phase
Geographic Atrophy Macular Degeneration Drug: Zimura Other: Sham Phase 2

Detailed Description:

Part 1: Approximately 66 subjects will be randomized in a 1:1:1 ratio to the following dose groups:

  • Zimura Dose Administration 1
  • Zimura Dose Administration 2
  • Sham Administration 1

Part 2: Approximately 135 subjects will be randomized in a 1:2:2 ratio to the following dose groups:

  • Zimura Dose Administration 3
  • Zimura Dose Administration 4
  • Sham Administration 2

Subjects will receive monthly intravitreal injections of Zimura or Sham for 18 months.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2b 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
Actual Study Start Date : January 2016
Estimated Primary Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose Group 1
Zimura Dose Administration 1
Drug: Zimura
Zimura Dose Administration 1
Other Name: avacincaptad pegol

Experimental: Dose Group 2
Zimura Dose Administration 2
Drug: Zimura
Zimura Dose Administration 2
Other Name: avaincaptad pegol

Sham Comparator: Dose Group 3
Sham Administration 1
Other: Sham
Sham Administration 1

Experimental: Dose Group 4
Zimura Dose Administration 3
Drug: Zimura
Zimura Dose Administration 3
Other Name: avacincaptad pegol

Experimental: Dose Group 5
Zimura Dose Administration 4
Drug: Zimura
Zimura Dose Administration 4
Other Name: avacincaptad pegol

Sham Comparator: Dose Group 6
Sham Administration 2
Other: Sham
Sham Administration 2




Primary Outcome Measures :
  1. Change in geographic atrophy (GA) [ Time Frame: 12 months ]
    Mean rate of change in GA measured by fundus autofluorescence (FAF)


Secondary Outcome Measures :
  1. Best Corrected Visual Acuity (BCVA) [ Time Frame: 12 months ]
    Mean change in BCVA (Early Treatment Diabetic Retinopathy Study [ETDRS] letter)



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02686658


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Locations
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United States, Arizona
Phoenix, Arizona, United States, 85053
Tucson, Arizona, United States, 85704
Tucson, Arizona, United States, 85710
United States, California
Campbell, California, United States, 95008
Fresno, California, United States, 93720
Fullerton, California, United States, 92835
La Jolla, California, United States, 92093
Mountain View, California, United States, 94040
Redlands, California, United States, 92374
Sacramento, California, United States, 95819
Sacramento, California, United States, 95841
Santa Ana, California, United States, 92705
United States, Colorado
Denver, Colorado, United States, 80210
United States, Florida
Altamonte Springs, Florida, United States, 32701
Boynton Beach, Florida, United States, 33426
Melbourne, Florida, United States, 32901
Saint Petersburg, Florida, United States, 33711
Stuart, Florida, United States, 34994
Winter Haven, Florida, United States, 33880
United States, Georgia
Augusta, Georgia, United States, 30909
Marietta, Georgia, United States, 30060
United States, Hawaii
Retina Consultants of Hawaii
'Aiea, Hawaii, United States, 96701
United States, Iowa
West Des Moines, Iowa, United States, 50266
United States, Kansas
Shawnee Mission, Kansas, United States, 66204
Wichita, Kansas, United States, 67214
United States, Maryland
Baltimore, Maryland, United States, 21209
Chevy Chase, Maryland, United States, 20815
United States, Massachusetts
Boston, Massachusetts, United States, 02114
Springfield, Massachusetts, United States, 01107
United States, Michigan
Grand Rapids, Michigan, United States, 49546
United States, Nevada
Henderson, Nevada, United States, 89052
Reno, Nevada, United States, 89502
United States, New York
Rochester, New York, United States, 14620
Syracuse, New York, United States, 13224
United States, North Carolina
Asheville, North Carolina, United States, 28803
Charlotte, North Carolina, United States, 28210
Hickory, North Carolina, United States, 28602
United States, Ohio
Cincinnati, Ohio, United States, 45242
Cleveland, Ohio, United States, 44130
Cleveland, Ohio, United States, 44136
United States, Oregon
Portland, Oregon, United States, 97221
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
West Mifflin, Pennsylvania, United States, 15122
United States, South Carolina
Ladson, South Carolina, United States, 29456
West Columbia, South Carolina, United States, 29169
United States, Texas
Abilene, Texas, United States, 79606
Amarillo, Texas, United States, 79106
Austin, Texas, United States, 78705
Grapevine, Texas, United States, 76051
Houston, Texas, United States, 77030
The Woodlands, Texas, United States, 77384
Willow Park, Texas, United States, 76087
United States, Utah
Salt Lake City, Utah, United States, 84107
Salt Lake City, Utah, United States, 84132
United States, Virginia
Richmond, Virginia, United States, 23235
Croatia
Clinical hospital center Osijek
Osijek, Croatia, 31000
Czechia
Fakultni Nemocnice Brno
Brno, Czechia, 62500
Faculty Hospital Hradec Kralove
Hradec Králové, Czechia, 50005
Fakultni nemocnice Olomouc
Olomouc, Czechia, 77900
Axon Clinical SRO
Praha, Czechia, 15000
Estonia
East Tallinn Central Hospital
Tallinn, Estonia, 10138
Dr.Kai Noor Eye Clinic
Tallinn, Estonia, 11412
Hungary
Peterfy Korhaz-Rendelointezet Orszagos Traumatologiai Intezet
Budapest, Hungary, 1076
Budapest, Hungary, 1083
Budapest, Hungary, 1106
Budapest, Hungary, 1133
Budapest, Hungary, 1145
Debrecen, Hungary, 4012
Pecs, Hungary, 7621
Szeged, Hungary, 6720
Veszprém, Hungary, 8200
Israel
Rambam Medical Center
Haifa, Israel, 3109601
Hadassah University Hospital
Jerusalem, Israel, 91120
Meir Medical Center
Kfar Saba, Israel, 4428164
Rabin Medical Center
Petah tikva, Israel, 4941492
Kaplan Medical Center
Reẖovot, Israel, 76100
Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel, 6423906
Latvia
Pauls Stradins Clinical University Hospital
Riga, Latvia, LV1002
Sponsors and Collaborators
Ophthotech Corporation

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Responsible Party: Ophthotech Corporation
ClinicalTrials.gov Identifier: NCT02686658     History of Changes
Other Study ID Numbers: OPH2003
First Posted: February 19, 2016    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ophthotech Corporation:
Geographic Atrophy (GA)
Dry age-related macular degeneration
AMD
Zimura
Anti-inflammatory
complement factor C5 inhibitor
ARC1905
avacincaptad pegol
Additional relevant MeSH terms:
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Macular Degeneration
Geographic Atrophy
Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical