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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 (AMD)

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ClinicalTrials.gov Identifier: NCT03525613
Recruitment Status : Recruiting
First Posted : May 15, 2018
Last Update Posted : October 2, 2018
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

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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.

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

    1. Total GA area must be ≥ 2.5 and ≤ 17.5 mm2 (1 and 7 disk areas [DA] respectively)
    2. 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.
    3. 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.
    4. Presence of any pattern of hyperautofluorescence in the junctional zone of GA. Absence of hyperautofluorescence (i.e. pattern = none) is exclusionary.
  5. Adequate clarity of ocular media, adequate pupillary dilation, and fixation to permit the collection of good quality images as determined by the Investigator.
  6. Meets the following criteria related to microperimetry:

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

    1. Women of non-child-bearing potential (WONCBP), or
    2. 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.
  8. 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.
  9. 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.

  1. GA secondary to a condition other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like plaquenil maculopathy in either eye.
  2. Spherical equivalent of the refractive error demonstrating > 6 diopters of myopia or an axial length >26 mm.
  3. 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.
  4. 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).
  5. Intraocular surgery (including lens replacement surgery) within 3 months prior to randomization.
  6. History of laser therapy in the macular region.
  7. 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.
  8. 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.
  9. Any contraindication to IVT injection including current ocular or periocular infection.
  10. History of prior intravitreal injection.
  11. Unable to perform microperimetry reliably in the opinion of the investigator
  12. Prior participation in another interventional clinical study for intravitreal therapies in either eye (including subjects receiving sham).
  13. Prior participation in another interventional clinical study for geographic atrophy in either eye including investigational oral medication and placebo.
  14. 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.
  15. 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.
  16. 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.
  17. 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: Natalie Gagne 617-977-5708 natalie@apellis.com

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Locations
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United States, California
California Retina Consultants Active, not recruiting
Bakersfield, California, United States, 93309
Retina Vitreous Associates Medical Group Recruiting
Beverly Hills, California, United States, 90211
Retinal Diagnostic Center Not yet recruiting
Campbell, California, United States, 95508
Retina Consultants of Orange County Not yet recruiting
Fullerton, California, United States, 92835
Atlantis Eyecare Not yet recruiting
Huntington Beach, California, United States, 92647
University of California, San Diego, Jacobs Retina Not yet 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 Not yet recruiting
Pasadena, California, United States, 91105
Retina Consultants San Diego Not yet recruiting
Poway, California, United States, 92064
Retinal Consultants Med Group, Inc. Recruiting
Sacramento, California, United States, 95819
UCSF Not yet recruiting
San Francisco, California, United States, 94143
Orange County Retina Medical Group Not yet recruiting
Santa Ana, California, United States, 92705
California Retina Consultants Recruiting
Santa Barbara, California, United States, 93103
American Institute of Research Not yet recruiting
Whittier, California, United States, 90603
United States, Colorado
Southwest Retina Research Center, LLC Not yet recruiting
Durango, Colorado, United States, 81301
Colorado Retina Associates Not yet recruiting
Golden, Colorado, United States, 80401
United States, Connecticut
Retina Group of New England Recruiting
New London, Connecticut, United States, 06320
United States, Florida
Blue Ocean Clinical Research Not yet recruiting
Clearwater, Florida, United States, 33761
Bascom Palmer Eye Institute Not yet recruiting
Miami, Florida, United States, 33136
Bascom Palmer Eye Institute Naples Not yet recruiting
Naples, Florida, United States, 34103
Retina Specialty Institute Not yet recruiting
Pensacola, Florida, United States, 32503
Center for Retina and Macular Disease Not yet recruiting
Winter Haven, Florida, United States, 33880
United States, Georgia
Southeast Retina Center, PC Not yet recruiting
Augusta, Georgia, United States, 30909
United States, Illinois
Gailey Eye Clinic Retina Center Not yet recruiting
Bloomington, Illinois, United States, 61704
Northwestern Feinberg School of Medicine Not yet recruiting
Chicago, Illinois, United States, 60611
Rush University Medical Center Not yet recruiting
Chicago, Illinois, United States, 60612
United States, Indiana
Midwest Eye Institute Not yet recruiting
Indianapolis, Indiana, United States, 46290
United States, Kentucky
Retina and Vitreous Associates of Kentucky, PSC dba Retina Associates of Kentucky Not yet recruiting
Lexington, Kentucky, United States, 40509
United States, Louisiana
Retina Associates New Orleans Not yet recruiting
Metairie, Louisiana, United States, 70006
United States, Maryland
The Retina Care Center Not yet recruiting
Baltimore, Maryland, United States, 21209
The Retina Group of Washington Not yet recruiting
Chevy Chase, Maryland, United States, 20815
Cumberland Valley Retina Center Not yet recruiting
Hagerstown, Maryland, United States, 21740
Mid Atlantic Retina Specialists Not yet recruiting
Hagerstown, Maryland, United States, 21740
United States, Massachusetts
Tufts Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02116
Retina Research Institute at New England Retina Consultants Not yet recruiting
Springfield, Massachusetts, United States, 01107
United States, Michigan
University of Michigan Kellogg Eye Center Not yet recruiting
Ann Arbor, Michigan, United States, 48105
Associated Retinal Consultants, P.C Not yet recruiting
Grand Rapids, Michigan, United States, 49564
United States, Minnesota
VitreoRetinal Surgery PA Not yet recruiting
Minneapolis, Minnesota, United States, 55435
United States, Nevada
Sierra Eye Associates Not yet recruiting
Reno, Nevada, United States, 89502
United States, New Jersey
NJ Retina Not yet recruiting
Toms River, New Jersey, United States, 08755
United States, New York
Ophthalmic Consultants of Long Island Not yet 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 Not yet recruiting
New York, New York, United States, 10022
United States, North Carolina
Duke University, Duke Eye Center Not yet recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
AMA Eye Research Institute Not yet recruiting
Marysville, Ohio, United States, 42040
United States, Oklahoma
RVC Oklahoma Not yet recruiting
Edmond, Oklahoma, United States, 73013
United States, Pennsylvania
Mid Atlantic Retina Not yet recruiting
Bethlehem, Pennsylvania, United States, 18017
Mid Atlantic Retina, Wills Eye Hospital Not yet recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Tennessee Retina, PC Not yet recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Retina Research Institute of Texas Not yet recruiting
Abilene, Texas, United States, 79606
Texas Retina Associates Not yet recruiting
Dallas, Texas, United States, 75231
Houston Eye Associates Not yet recruiting
Houston, Texas, United States, 77025
Retina Consultants of Houston, PA Recruiting
Houston, Texas, United States, 77030
Retinal Consultants of San Antonio Not yet recruiting
San Antonio, Texas, United States, 78240
Strategic Clinical Research Group Not yet recruiting
Willow Park, Texas, United States, 01107
United States, Utah
University of Utah - John A. Moran Center Not yet recruiting
Salt Lake City, Utah, United States, 84132
United States, Wisconsin
University of Wisconsin Not yet recruiting
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
Apellis Pharmaceuticals, Inc.

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Responsible Party: Apellis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03525613     History of Changes
Other Study ID Numbers: APL2-304
First Posted: May 15, 2018    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Atrophy
Geographic Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical