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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03525613
Recruitment Status : Recruiting
First Posted : May 15, 2018
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
Apellis Pharmaceuticals, Inc.

Brief Summary:
This is a 30-month, Phase III, multicenter, randomized, double-masked, sham-injection controlled study to assess the efficacy and safety of multiple IVT injections of APL-2 in subjects with GA secondary to AMD.

Condition or disease Intervention/treatment Phase
Geographic Atrophy Drug: APL-2 Other: Sham Procedure Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Multi-Center, Randomized, Double-Masked, Sham Controlled 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 (AMD)
Actual Study Start Date : August 30, 2018
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: APL-2 15mg 0.1 mL Monthly for 24 months
A single dose of 15 mg APL-2/0.1 mL will be administered via intravitreal injection in this study. Subjects will receive an injection every month
Drug: APL-2
Complement (C3) Inhibitor

Experimental: APL-2 15mg 0.1 mL EOM for 24 months
A single dose of 15 mg APL-2/0.1 mL will be administered via intravitreal injection in this study. Subjects will receive an injection every other month
Drug: APL-2
Complement (C3) Inhibitor

Experimental: Sham Procedure Monthly for 24 months
Sham Procedure monthly for 24 months
Other: Sham Procedure
Subjects will receive a Sham procedure every month

Experimental: Sham Procedure Every Other Month for 24 months
Sham Procedure every other month for 24 months
Other: Sham Procedure
Subjects will receive a Sham procedure every other month




Primary Outcome Measures :
  1. Change from Baseline to Month 12 in total area of GA lesion(s) in the study eye (in mm2 ) based on Fundus Autofluorescence (FAF) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Incidence and severity of ocular and systemic treatment-emergent adverse events [ Time Frame: 30 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The study eye must meet all inclusion criteria. If both eyes meet the inclusion criteria, the eye with the worst visual acuity at the screening visit will be designated as the study eye. If both eyes have the same visual acuity, the right eye will be selected as the study eye.

Ocular- specific inclusion criteria apply to the study eye only, unless otherwise specified.

  • Age ≥ 60 years.
  • Normal Luminance best corrected visual acuity of 24 letters or better using Early Treatment Diabetic Retinopathy Study (ETDRS) charts (approximately 20/320 Snellen equivalent).
  • Clinical diagnosis of GA of the macula secondary to AMD as determined by the Investigator and confirmed by the Reading Center.
  • The GA lesion must meet the following criteria as determined by the central reading center's assessment of Fundus Autofluorescence (FAF) imaging at screening:

    • Total GA area must be ≥ 2.5 and ≤ 17.5 mm2 (1 and 7 disk areas [DA] respectively)
    • If GA is multifocal, at least one focal lesion must be ≥ 1.25 mm2 (0.5 DA), with the overall aggregate area of GA, as specified above in 4a.
    • The entire GA lesion must be completely visualized on the macula centered image and must be able to be imaged in its entirety and not contiguous with any areas of peripapillary atrophy.
    • Presence of any pattern of hyperautofluorescence in the junctional zone of GA. Absence of hyperautofluorescence (i.e. pattern = none) is exclusionary.
  • Adequate clarity of ocular media, adequate pupillary dilation, and fixation to permit the collection of good quality images as determined by the Investigator.
  • Meets the following criteria related to microperimetry:

    • Able to detect fixation target.
    • Total elapsed time to complete the 10-2 68 point exam is ≤ 30 minutes in duration.
    • Reliability test ratio must be ≤ 20%.
    • Subject is willing and able to undertake microperimetry assessment in the opinion of the investigator.
  • Female subjects must be:

    • Women of non-child-bearing potential (WONCBP), or
    • Women of child-bearing potential (WOCBP) with a negative pregnancy test at screening and must agree to use protocol defined methods of contraception for the duration of the study and refrain from breastfeeding for the duration of the study.
  • Males with female partners of child-bearing potential must agree to use protocol defined methods of contraception and agree to refrain from donating sperm for the duration of the study.
  • Willing and able to give informed consent and to comply with the study procedures and assessments.

Exclusion Criteria:

Ocular specific exclusion criteria apply to the study eye only, unless otherwise specified.

  • GA secondary to a condition other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like plaquenil maculopathy in either eye.
  • Spherical equivalent of the refractive error demonstrating > 6 diopters of myopia or an axial length >26 mm.
  • Any history or active choroidal neovascularization (CNV), associated with AMD or any other cause, including any evidence of retinal pigment epithelium rips or evidence of neovascularization anywhere based on SD-OCT imaging and/or fluorescein angiography as assessed by the Reading Center.
  • Presence of an active ocular disease that in the opinion of the Investigator compromises or confounds visual function, including but not limited to, uveitis, other macular diseases (e.g. clinically significant epiretinal membrane (ERM), full thickness macular hole or uncontrolled glaucoma/ocular hypertension. Benign conditions in the opinion of the investigator such as peripheral retina dystrophy are not exclusionary).
  • Intraocular surgery (including lens replacement surgery) within 3 months prior to randomization.
  • History of laser therapy in the macular region.
  • Aphakia or absence of the posterior capsule. Note: YAG laser posterior capsulotomy for posterior capsule opacification done at least 60 days prior to screening is not exclusionary.
  • Any ocular condition other than GA secondary to AMD that may require surgery or medical intervention during the study period or, in the opinion of the Investigator, could compromise visual function during the study period.
  • Any contraindication to IVT injection including current ocular or periocular infection.
  • History of prior intravitreal injection.
  • Unable to perform microperimetry reliably in the opinion of the investigator
  • Prior participation in another interventional clinical study for intravitreal therapies in either eye (including subjects receiving sham).
  • Prior participation in another interventional clinical study for geographic atrophy in either eye including investigational oral medication and placebo.
  • Participation in any systemic experimental treatment or any other systemic investigational new drug within 6 weeks or 5 half-lives of the active ingredient (whichever is longer) prior to the start of study treatment. Note: clinical trials solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary.
  • Medical or psychiatric conditions that, in the opinion of the investigator, make consistent follow-up over the 24-month treatment period unlikely, or would make the subject an unsafe study candidate.
  • Any screening laboratory value (hematology, serum chemistry or urinalysis) that in the opinion of the Investigator is clinically significant and not suitable for study participation.
  • Known hypersensitivity to fluorescein sodium for injection or hypersensitivity to APL-2 or any of the excipients in APL-2 solution.

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): NCT03525613


Contacts
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Contact: Apellis Clinical Trial information Line 1-833-284-6361 clinicaltrials@apellis.com

Locations
Hide Hide 96 study locations
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United States, Arizona
Arizona Retina & Vitreous Consultants Recruiting
Phoenix, Arizona, United States, 85021
United States, California
California Retina Consultants Recruiting
Bakersfield, California, United States, 93309
Retina Vitreous Associates Medical Group Recruiting
Beverly Hills, California, United States, 90211
Retinal Diagnostic Center Recruiting
Campbell, California, United States, 95508
Retina Consultants of Orange County Recruiting
Fullerton, California, United States, 92835
Atlantis Eyecare Recruiting
Huntington Beach, California, United States, 92647
University of California, San Diego, Jacobs Retina Recruiting
La Jolla, California, United States, 92093
Byers Eye Institute at Stanford, Stanford School of Medicine Not yet recruiting
Palo Alto, California, United States, 94303
Doheny Eye Center UCLA Recruiting
Pasadena, California, United States, 91105
Retina Consultants San Diego Recruiting
Poway, California, United States, 92064
Retinal Consultants Med Group, Inc. Recruiting
Sacramento, California, United States, 95819
Orange County Retina Medical Group Recruiting
Santa Ana, California, United States, 92705
California Retina Consultants Recruiting
Santa Barbara, California, United States, 93103
United States, Colorado
Southwest Retina Research Center, LLC Recruiting
Durango, Colorado, United States, 81301
Colorado Retina Associates Recruiting
Golden, Colorado, United States, 80401
United States, Connecticut
Retina Group of New England Recruiting
Waterford, Connecticut, United States, 06385
United States, Florida
Blue Ocean Clinical Research / The Macula Center Recruiting
Clearwater, Florida, United States, 33761
National Ophthalmic Research Institute (Retina Consultants of Southwest Florida) Recruiting
Fort Myers, Florida, United States, 33912
Bascom Palmer Eye Institute Recruiting
Miami, Florida, United States, 33136
Bascom Palmer Eye Institute of Naples Recruiting
Naples, Florida, United States, 34103
Retina Specialty Institute Recruiting
Pensacola, Florida, United States, 32503
Center for Retina and Macular Disease Recruiting
Winter Haven, Florida, United States, 33880
United States, Georgia
Southeast Retina Center, PC Recruiting
Augusta, Georgia, United States, 30909
United States, Illinois
Gailey Eye Clinic Retina Center Recruiting
Bloomington, Illinois, United States, 61704
Northwestern Feinberg School of Medicine Recruiting
Chicago, Illinois, United States, 60611
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
United States, Indiana
Midwest Eye Institute Recruiting
Indianapolis, Indiana, United States, 46290
United States, Kentucky
Retina and Vitreous Associates of Kentucky, PSC dba Retina Associates of Kentucky Recruiting
Lexington, Kentucky, United States, 40509
United States, Louisiana
Retina Associates New Orleans Recruiting
Metairie, Louisiana, United States, 70006
United States, Maryland
The Retina Care Center Recruiting
Baltimore, Maryland, United States, 21209
The Retina Group of Washington Recruiting
Chevy Chase, Maryland, United States, 20815
Cumberland Valley Retina Center Recruiting
Hagerstown, Maryland, United States, 21740
Mid Atlantic Retina Specialists Recruiting
Hagerstown, Maryland, United States, 21740
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02116
New England Retina Consultants Recruiting
Springfield, Massachusetts, United States, 01107
United States, Michigan
Michigan Medicine Kellogg Eye Center Recruiting
Ann Arbor, Michigan, United States, 48105
Associated Retinal Consultants, P.C Recruiting
Grand Rapids, Michigan, United States, 49564
United States, Minnesota
VitreoRetinal Surgery PA Recruiting
Minneapolis, Minnesota, United States, 55435
United States, Nevada
Sierra Eye Associates Recruiting
Reno, Nevada, United States, 89502
United States, New Jersey
Retina Center of NJ, LLC Recruiting
Bloomfield, New Jersey, United States, 07003
NJ Retina Recruiting
Toms River, New Jersey, United States, 08755
United States, New Mexico
Vision Research Center Eye Associates of NM Not yet recruiting
Albuquerque, New Mexico, United States, 87109
United States, New York
Ophthalmic Consultants of Long Island Recruiting
Lynbrook, New York, United States, 11563
New York Eye and Ear Infirmary of Mount Sinai Not yet recruiting
New York, New York, United States, 10003
Vitreous Retina Macula Consultants of NY Recruiting
New York, New York, United States, 10022
United States, North Carolina
Duke University, Duke Eye Center Recruiting
Durham, North Carolina, United States, 27710
United States, Oklahoma
Research - Retina Vitreous Center Recruiting
Edmond, Oklahoma, United States, 73013
United States, Oregon
Oregon Retina, LLP Recruiting
Eugene, Oregon, United States, 97405
United States, Pennsylvania
Mid Atlantic Retina Recruiting
Bethlehem, Pennsylvania, United States, 18017
Retina Vitreous Consultants Recruiting
Monroeville, Pennsylvania, United States, 15146
Mid Atlantic Retina, Wills Eye Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
AIO Visionary Eye Care Not yet recruiting
West Mifflin, Pennsylvania, United States, 15122
United States, Tennessee
Tennessee Retina, PC Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Retina Research Institute of Texas Recruiting
Abilene, Texas, United States, 79606
Texas Retina Associates Recruiting
Dallas, Texas, United States, 75231
Houston Eye Associates Recruiting
Houston, Texas, United States, 77025
Retina Consultants of Houston, PA Recruiting
Houston, Texas, United States, 77030
Medical Center Ophthalmology Associates Recruiting
San Antonio, Texas, United States, 78240
Retina Associates of South Texas Recruiting
San Antonio, Texas, United States, 78240
Retinal Consultants of San Antonio Recruiting
San Antonio, Texas, United States, 78240
Strategic Clinical Research Group Recruiting
Willow Park, Texas, United States, 76087
United States, Utah
University of Utah - John A. Moran Center Recruiting
Salt Lake City, Utah, United States, 84132
United States, Virginia
Emerson Clinical Research Institute Recruiting
Falls Church, Virginia, United States, 22046
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53705
Australia, New South Wales
Marsden Eye Specialist Recruiting
Parramatta, New South Wales, Australia, 2150
Australia, South Australia
Adelaide Eye & Retina Clinic Not yet recruiting
Adelaide, South Australia, Australia, 5000
Australia, South Block
Save Sight Institute Recruiting
Sydney, South Block, Australia, 2000
Australia, Western Australia
Lions Eye Institute Not yet recruiting
Nedlands, Western Australia, Australia, 6009
Australia
Strathfield Retina Clinic Recruiting
Strathfield, Australia, 2135
Sydney West Retina Recruiting
Westmead, Australia, 2145
Brazil
UNIFESP - Federal University Recruiting
São Paulo, Brazil, 04021-001
Czechia
AXON Clinical S.R.O Recruiting
Praha, Czechia, 150 00
Gemini Eye Clinic Recruiting
Zlín, Czechia, 76001
France
CHU de Bordeaux Recruiting
Bordeaux, France, 33076
Centre Hospitalier Intercommunal de Créteil Not yet recruiting
Créteil, France, 94010
Hopital Lariboisière Recruiting
Paris, France, 75010
CHNO des Quinze-Vingts Recruiting
Paris, France, 75012
Centre Ophtalmologique d'Imagerie et Laser Recruiting
Paris, France, 75015
CHU de Strasbourg Hopital Civil Recruiting
Strasbourg, France, 67091
Clinique du Val d'Ouest Recruiting
Écully, France, 69130
Germany
Universitäts-Augenklinik Bonn Not yet recruiting
Bonn, Germany, 53127
University Opthalmology Clinic Recruiting
Freiburg im Breisgau, Germany, 79106
Universitätsklinikum Schleswig-Holstein Recruiting
Lübeck, Germany, 23538
Augenklinik der LMU München Recruiting
München, Germany, 80336
Augenzentrum am St. Franziskus-Hospital Recruiting
Münster, Germany, 48145
STZ Eyetrial Recruiting
Tübingen, Germany, 72076
Netherlands
Academisch Medisch Centrum Recruiting
Amsterdam, Netherlands, 1105 AZ
Radboud University Medical Center Oogheelkunde Recruiting
Nijmegen, Netherlands, 6525
New Zealand
Southern Eye Specialists Recruiting
Christchurch, New Zealand, 8013
Poland
Oculomedica Eye Centre Recruiting
Bydgoszcz, Poland, 85-316
Oftalmika Eye Hospital Recruiting
Bydgoszcz, Poland, 85-631
Eye Surgery Center Professor Zagorski Recruiting
Rzeszów, Poland, 35-017
United Kingdom
The Royal Victoria Hospital Recruiting
Belfast, United Kingdom, BT12 6BA
Liverpool University Hospitals NHS Foundation Trust Recruiting
Liverpool, United Kingdom, L7 8XP
Sunderland Eye Infirmary Not yet recruiting
Sunderland, United Kingdom, SR2 9HP
York Teaching Hospital NHS Foundation Trust Recruiting
York, United Kingdom, YO31 8HE
Sponsors and Collaborators
Apellis Pharmaceuticals, Inc.
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Responsible Party: Apellis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03525613    
Other Study ID Numbers: APL2-304
First Posted: May 15, 2018    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Degeneration
Geographic Atrophy
Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical