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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03525600
Recruitment Status : Active, not recruiting
First Posted : May 15, 2018
Last Update Posted : September 16, 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 31, 2018
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : January 30, 2023

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 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) as Measured by Fundus Autofluorescence (FAF) [ Time Frame: Baseline, 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.
  • Female subjects must be:

    • Women of non-child-bearing potential (WONCBP), or
    • Women of child-bearing potential (WOCBP) with a negative serum 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.
  • 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): NCT03525600


Locations
Hide Hide 141 study locations
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United States, Arizona
Retinal Research Institute
Phoenix, Arizona, United States, 85014
Associated Retina Consultants, Ltd
Phoenix, Arizona, United States, 85020
United States, California
Retina Institute of California dba Acuity Eye Grp
Arcadia, California, United States, 91007
California Retina Consultants
Bakersfield, California, United States, 93309
Retina Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
The Retina Partners
Encino, California, United States, 91436
The Gavin Herbert Eye Institute/UC Irvine
Irvine, California, United States, 92697
Northern California Retina Vitreous Associates
Mountain View, California, United States, 94040
Retina Institute of California Medical Group
Palm Desert, California, United States, 92260
Byers Eye Institute at Standford, Stanford School of Medicine
Palo Alto, California, United States, 94303
Retina Consultants San Diego
Poway, California, United States, 92064
Retina Consultants of Southern California
Redlands, California, United States, 92374
California Retina Consultants
Santa Barbara, California, United States, 93103
Bay Area Retina Associates
Walnut Creek, California, United States, 94598
United States, Connecticut
Danbury Eye Physicians & Surgeons, P.C. - Danbury
Danbury, Connecticut, United States, 06810
New England Retina Associates
Hamden, Connecticut, United States, 06518
Retina Group of New England,PC
Waterford, Connecticut, United States, 06385
United States, Florida
Florida Eye Microsurgical Institute, Inc.
Boynton Beach, Florida, United States, 33426
Pinnacle Research Institute
Fort Lauderdale, Florida, United States, 33309
Retina Health Center
Fort Myers, Florida, United States, 33907
Bascom Palmer Eye Institute
Palm Beach Gardens, Florida, United States, 33418
Eye Associates of Pinellas
Pinellas Park, Florida, United States, 33782
East Florida Eye Institute
Stuart, Florida, United States, 34994
Southern Vitreoretinal Associates
Tallahassee, Florida, United States, 32308
Retina Associates of Florida
Tampa, Florida, United States, 33609
University of South Florida (USF) Eye Institute
Tampa, Florida, United States, 33612
United States, Georgia
Southeast Retina Center, PC
Augusta, Georgia, United States, 30909
Georgia Retina
Marietta, Georgia, United States, 30060
United States, Indiana
Midwest Eye Institute
Indianapolis, Indiana, United States, 46290
United States, Kansas
Sabates Eye Center
Leawood, Kansas, United States, 66211
United States, Maryland
Elman Retina Group, PA
Baltimore, Maryland, United States, 21236
Cumberland Valley Retina Consultants, PC
Hagerstown, Maryland, United States, 21740
Mid Atlantic Retina Specialists
Hagerstown, Maryland, United States, 21740
Retina Specialists
Towson, Maryland, United States, 21204
United States, Massachusetts
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
New England Retina Consultants, PC
Springfield, Massachusetts, United States, 01107
United States, Michigan
Associated Retinal Consultants, P.C
Grand Rapids, Michigan, United States, 49546
Retina Specialists of Michigan / Foundation for Vision
Grand Rapids, Michigan, United States, 49546
Retina Consultants of Michigan
Southfield, Michigan, United States, 48034
Associated Retinal Consultants PC
Traverse City, Michigan, United States, 49686
United States, Nevada
Sierra Eye Associates
Reno, Nevada, United States, 89503
United States, New Jersey
Retina Associates of New Jersey (NJ Retina)
Teaneck, New Jersey, United States, 07666
United States, New York
Long Island Vitreoretinal Consultants
Great Neck, New York, United States, 11021
Vitreous Retina Macula Consultants of NY
New York, New York, United States, 10022
United States, North Carolina
Western Carolina Retinal Associates
Asheville, North Carolina, United States, 28803
Charlotte Eye Ear Nose and Throat Associates, PS
Charlotte, North Carolina, United States, 28210
Graystone Eye
Hickory, North Carolina, United States, 28602
United States, Ohio
Retina Associates of Cleveland, Inc.
Cleveland, Ohio, United States, 44122
Retina Associates of Cleveland, Inc
Cleveland, Ohio, United States, 44122
Retina Associates of Cleveland
Cleveland, Ohio, United States, 44130
Cleveland Clinic, Cole Eye Institute
Cleveland, Ohio, United States, 44195
The Ohio State University
Columbus, Ohio, United States, 43212
Retina Associates of Cleveland, Inc.
Youngstown, Ohio, United States, 44505
United States, Oregon
Retina Northwest, PC
Portland, Oregon, United States, 97221
Eye Health Northwest
Portland, Oregon, United States, 97225
United States, Pennsylvania
Mid Atlantic Retina
Philadelphia, Pennsylvania, United States, 19006
United States, South Dakota
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Tennessee Retina, PC
Nashville, Tennessee, United States, 37203
United States, Texas
Retina Research Institute of Texas
Abilene, Texas, United States, 79606
Southwest Retina Specialists
Amarillo, Texas, United States, 79106
Retina Consultants of Austin (Retina Research Center)
Austin, Texas, United States, 78705
Retina Consultants of Houston, PA
Houston, Texas, United States, 77030
Valley Retina Institute, PA
McAllen, Texas, United States, 78503
Medical Center Ophthalmology Associates
San Antonio, Texas, United States, 78240
Retinal Consultants of San Antonio
San Antonio, Texas, United States, 78240
Retina Consultants of Houston
The Woodlands, Texas, United States, 77384
United States, Utah
Retina Associates of Utah, PC
Murray, Utah, United States, 84107
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22903
The Retina Group of Washington
Fairfax, Virginia, United States, 22031
Virginia Retina Center
Warrenton, Virginia, United States, 20186
United States, Washington
Vitreoretinal Associates of Washington
Bellevue, Washington, United States, 98004
Spokane Eye Clinical Research
Spokane, Washington, United States, 99204
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53715
Argentina
Fundacion Zambrano
Buenos Aires, Capital Federal, Argentina, C1023 AAQ
Microcirugia Ocular
Rosario, Corrientes, Argentina, 2000
Grupo Laser Vision
Rosario, Santa Fe, Argentina, S2000 AZH
Organizacion Medica de investigacion
Buenos Aires, Argentina, C1015 ABO
Centro Oftalmologico Dr Charles
Buenos Aires, Argentina, C1116ABA
Diagnostico Ocular
Buenos Aires, Argentina, C1425BGE
Centro Privado de Ojos Romagosa SA
Córdoba, Argentina, X5000AAJ
Instituto Oftalmologico de Cordoba
Córdoba, Argentina, X5000III
Oftar Mendoza SRL
Mendoza, Argentina, 5500
Oftalmologos Especialistas
Rosario, Argentina, 1288
Australia, New South Wales
Sydney Retina
Sydney, New South Wales, Australia, 2000
Australia, Victoria
Centre for Eye Research Australia
East Melbourne, Victoria, Australia, 3002
Australia
Retina and Eye Consultants
Hurstville, Australia, NSW 2220
Brazil
Clinica Ocular Oftalmologia LTDA
Vitória, Espirito Santo, Brazil, 29055-45
Clinica Oftalmologica Sao Lucas
Osasco, Sao Paulo, Brazil, 06010-130
IPEPO - Instituto Da Visao
São Paulo, Vila Clementino, Brazil, 04038-032
Instituto da Visão - Hospital de Olhos Ltda
Belo Horizonte, Brazil, 32150-274
Hospital De Clinicas De Porto Alegre
Porto Alegre, Brazil, 90036-903
UNIFESP - Federal University
São Paulo, Brazil, 04021-001
Canada, Ontario
Ivey Eye Institute
London, Ontario, Canada, N6A
University of Ottawa Eye Institute
Ottawa, Ontario, Canada, K1H 8L6
DRY AMD Clinic - St. Michael's Hospital
Toronto, Ontario, Canada, M5C 1R6
Canada
Retina Centre of Ottawa
Ottawa, Canada, K2B 7E9
Czechia
Fakultní nemocnice Ostrava
Ostrava-Poruba, Czechia, 708 52
OFTEX Eye Clinic
Pardubice, Czechia, 53002
AXON Clinical, S.R.O.
Praha, Czechia, 150 00
University Hospital Kralovske Vinochrady
Vinohrady, Czechia, 100 34
France
Centre Hospitalier Intercommunal de Créteil
Créteil, France
Hopital de la Croix-Rousse
Lyon, France, 69004
Centre Monticelli Paradis
Marseille, France, 13008
CHU de Nantes - Hotel Dieu
Nantes, France, 44093
Centre Ophtalmologique de l´Odéon
Paris, France, 75006
Centre Ophthalmologique Saint-Exupery
Saint-Cyr-sur-Loire, France, 37540
Maison Rouge Ophthalmologic Center
Strasbourg, France, 67000
Germany
Universitäts-Augenklinik Bonn
Bonn, Germany, 53127
University Hospital Cologne
Cologne, Germany, 50937
Klinikum der Stadt Ludwigshafen gGmbH
Ludwigshafen, Germany, 67063
Klinikum rechts der Isar
München, Germany, 81675
Universitätsklinikum Regensburg
Regensburg, Germany, 93053
University Hospital Würzburg
Würzburg, Germany, 97080
Israel
Shamir Medical Center
Be'er Ya'aqov, Israel, 7030000
Rambam Medical Center
Haifa, Israel, 3109601
Meir Medical Center
Kfar Saba, Israel, 4428164
Rabin Medical Center
Petah tikva, Israel, 49100
Kaplan Medical Center
Reẖovot, Israel, 76100
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Italy
Ospedale San Raffaele
Milano, Italy, 20132
Luigi Sacco Hospital
Milano, Italy, 20157
New Zealand
Retina Specialist
Auckland, New Zealand, 1052
Hamilton Eye Clinic
Hamilton, New Zealand, 3204
Poland
Oftalmika Eye Hospital
Bydgoszcz, Poland, 85-631
Centrum Diagnostyki i Mikrochirurgii Oka - LENS
Olsztyn, Poland, 10-424
Centrum Medyczne UNO-MED
Tarnow, Poland, 33-100
Jasne Blonia Eye Clinic
Łódź, Poland, 91-134
Puerto Rico
Emanuelli Research and Development Center
Arecibo, Puerto Rico, 00612
Spain
Centro Médico Teknon
Barcelona, Spain, 08022
Instituto Oftalmologico Gómez-Ulla
Santiago De Compostela, Spain, 15706
Hospital Universitario Rio Hortega
Valladolid, Spain, 47006
United Kingdom
Moorfields Eye Hospital NHS Foundation Trust
London, England, United Kingdom, EC1V 2PD
Eye Clinic, Acre Mill Outpatients, Huddersfield Royal Infirmary
Huddersfield, West Yorkshire, United Kingdom, HD3 3EA
Bristol Eye Hospital
Bristol, United Kingdom, BS1 2LX
St James's University Hospital
Leeds, United Kingdom, LS9 7TF
Leicester Royal Infirmary
Leicester, United Kingdom, LEI 5WW
London North West University Hospital Trust
London, United Kingdom, NW10 7NS
King's College Hospital NHS Trust
London, United Kingdom, SE5 9RS
Oxford Eye Hospital
Oxford, United Kingdom, OX3 9DU
Salisbury NHS Foundation Trust
Salisbury, United Kingdom, SP2 8BJ
Sunderland Eye Infirmary
Sunderland, United Kingdom, SR2 9HP
Sponsors and Collaborators
Apellis Pharmaceuticals, Inc.
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Responsible Party: Apellis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03525600    
Other Study ID Numbers: APL2-303
First Posted: May 15, 2018    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 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