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Trial record 5 of 13 for:    Apellis

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

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ClinicalTrials.gov Identifier: NCT03525600
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

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 : March 30, 2021
Estimated Study Completion Date : November 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 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 ]


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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. Female subjects must be:

    1. Women of non-child-bearing potential (WONCBP), or
    2. 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.
  7. 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.
  8. 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. Prior participation in another interventional clinical study for intravitreal therapies in either eye (including subjects receiving sham).
  12. Prior participation in another interventional clinical study for geographic atrophy in either eye including investigational oral medication and placebo.
  13. 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.
  14. 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.
  15. 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.
  16. 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


Contacts
Contact: Natalie Gagne 617-977-5708 natalie@apellis.com

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Locations
United States, Arizona
Retinal Research Institute Not yet recruiting
Phoenix, Arizona, United States, 85014
Associated Retina Consultants, Ltd Not yet recruiting
Phoenix, Arizona, United States, 85020
United States, California
California Retina Consultants Not yet recruiting
Bakersfield, California, United States, 93309
Retina Vitreous Associates Medical Group Not yet recruiting
Beverly Hills, California, United States, 90211
The Retina Partners Recruiting
Encino, California, United States, 91436
The Gavin Herbert Eye Institute/UC Irvine Not yet recruiting
Irvine, California, United States, 92697
USC Eye Institute Not yet recruiting
Los Angeles, California, United States, 90033
Acuity Eye Group & Retina Institute of CaliforniaPalm Not yet recruiting
Palm Desert, California, United States, 92260
Byers Eye Institute at Standford, Stanford School of Medicine Not yet recruiting
Palo Alto, California, United States, 94303
Retina Consultants San Diego Not yet recruiting
Poway, California, United States, 92064
California Retina Consultants Not yet recruiting
Santa Barbara, California, United States, 93103
Bay Area Retina Associates Not yet recruiting
Walnut Creek, California, United States, 94598
United States, Colorado
Retina Consultants of Southern Colorado, PC Not yet recruiting
Colorado Springs, Colorado, United States, 80909
United States, Connecticut
Danbury Eye Physicians & Surgeons, P.C. - Danbury Not yet recruiting
Danbury, Connecticut, United States, 06810
New England Retina Associates Not yet recruiting
New London, Connecticut, United States, 06320
United States, Florida
Florida Eye Microsurgical Institute, Inc. Not yet recruiting
Boynton Beach, Florida, United States, 33426
The Macula Center Not yet recruiting
Clearwater, Florida, United States, 33761
Retina Health Center Not yet recruiting
Fort Myers, Florida, United States, 33907
Bascom Palmer Eye Institute Not yet recruiting
Palm Beach Gardens, Florida, United States, 33418
Eye Associates of Pinellas Not yet recruiting
Pinellas Park, Florida, United States, 33782
East Florida Eye Institute Not yet recruiting
Stuart, Florida, United States, 34994
University of South Florida (USF) Eye Institute Not yet recruiting
Tampa, Florida, United States, 33612
United States, Georgia
Georgia Retina Active, not recruiting
Marietta, Georgia, United States, 30060
United States, Indiana
Midwest Eye Institute Not yet recruiting
Indianapolis, Indiana, United States, 46290
United States, Maryland
Elman Retina Group, PA Not yet recruiting
Baltimore, Maryland, United States, 21237
Cumberland Valley Retina Consultants, PC Not yet recruiting
Hagerstown, Maryland, United States, 21740
United States, Massachusetts
Ophthalmic Consultants of Boston Recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
Associated Retinal Consultants, P.C Not yet recruiting
Grand Rapids, Michigan, United States, 49546
Retina Consultants of Michigan Not yet recruiting
Southfield, Michigan, United States, 48034
Associated Retinal Consultants PC Not yet recruiting
Traverse City, Michigan, United States, 49686
United States, New Jersey
Retina Associates of New Jersey (NJ Retina) Not yet recruiting
Teaneck, New Jersey, United States, 07666
United States, New York
Long Island Vitreoretinal Consultants Not yet recruiting
Great Neck, New York, United States, 11021
Vitreous Retina Macula Consultants of NY Not yet recruiting
New York, New York, United States, 10022
United States, North Carolina
Asheville Eye Assoc Western Carolina Retinal Associates Recruiting
Asheville, North Carolina, United States, 28803
Charlotte Eye Ear Nose and Throat Associates, PS Active, not recruiting
Charlotte, North Carolina, United States, 28210
Graystone Eye Not yet recruiting
Hickory, North Carolina, United States, 28602
United States, Ohio
Retina Associates of Cleveland, Inc. Not yet recruiting
Cleveland, Ohio, United States, 44122
The Ohio State University Not yet recruiting
Columbus, Ohio, United States, 43212
Cleveland Clinic, Cole Eye Institute Not yet recruiting
Ohio City, Ohio, United States, 44195
Retina Associates of Cleveland, Inc Recruiting
Youngstown, Ohio, United States, 44505
United States, Oregon
Oregon Retina Institute Not yet recruiting
Medford, Oregon, United States, 97504
Retina Northwest, PC Not yet recruiting
Portland, Oregon, United States, 97221
United States, Pennsylvania
Mid Atlantic Retina Not yet recruiting
Huntingdon, Pennsylvania, United States, 19006
United States, South Dakota
Black Hills Regional Eye Institute Active, not recruiting
Rapid City, South Dakota, United States, 57701
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
Retina Consultants of Austin (Retina Research Center) Not yet recruiting
Austin, Texas, United States, 78705
Retina Consultants of Houston Recruiting
Houston, Texas, United States, 77030
Valley Retina Institute, PA Not yet recruiting
McAllen, Texas, United States, 78503
Medical Center Ophthalmology Associates Not yet recruiting
San Antonio, Texas, United States, 78240
Retinal Consultants of San Antonio Not yet recruiting
San Antonio, Texas, United States, 79240
Retina Consultants of Houston Not yet recruiting
The Woodlands, Texas, United States, 77384
United States, Virginia
University of Virginia Not yet recruiting
Charlottesville, Virginia, United States, 22903
The Retina Group of Washington Not yet recruiting
Fairfax, Virginia, United States, 22031
United States, Washington
Vitreoretinal Associates of Washington Not yet recruiting
Bellevue, Washington, United States, 98004
University of Washington/ Jules Stein Not yet recruiting
Seattle, Washington, United States, 98105
Spokane Eye Clinical Research Recruiting
Spokane, Washington, United States, 99204
United States, Wisconsin
University of Wisconsin Not yet recruiting
Madison, Wisconsin, United States, 53715
Sponsors and Collaborators
Apellis Pharmaceuticals, Inc.

Responsible Party: Apellis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03525600     History of Changes
Other Study ID Numbers: APL2-303
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

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Macular Degeneration
Atrophy
Geographic Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical