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)



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:60 - Any
Updated:10/4/2018
Start Date:August 30, 2018
End Date:December 30, 2022
Contact:Natalie Gagne
Email:natalie@apellis.com
Phone:617-977-5708

Use our guide to learn which trials are right for you!

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)

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.


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.
We found this trial at
57
sites
Grand Rapids, Michigan 45946
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
?
mi
from
Boston, MA
Click here to add this to my saved trials
900 Northwest 17th Street
Miami, Florida 33136
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Abilene, TX
Click here to add this to my saved trials
Ann Arbor, Michigan 48105
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Augusta, Georgia 30909
?
mi
from
Augusta, GA
Click here to add this to my saved trials
Bakersfield, California 93309
?
mi
from
Bakersfield, CA
Click here to add this to my saved trials
Baltimore, Maryland 21209
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Bethlehem, Pennsylvania 18020
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
Beverly Hills, California 90211
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
Bloomington, Illinois 61704
?
mi
from
Bloomington, IL
Click here to add this to my saved trials
Campbell, California 95008
?
mi
from
Campbell, CA
Click here to add this to my saved trials
Chevy Chase, Maryland 20815
?
mi
from
Chevy Chase, MD
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Clearwater, Florida 33761
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Dallas, Texas 75231
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Durango, Colorado 81301
?
mi
from
Durango, CO
Click here to add this to my saved trials
Durham, North Carolina 27710
?
mi
from
Durham, NC
Click here to add this to my saved trials
Edmond, Oklahoma 73013
?
mi
from
Edmond, OK
Click here to add this to my saved trials
Fullerton, California 92835
?
mi
from
Fullerton, CA
Click here to add this to my saved trials
Golden, Colorado 80401
?
mi
from
Golden, CO
Click here to add this to my saved trials
Hagerstown, Maryland 21740
?
mi
from
Hagerstown, MD
Click here to add this to my saved trials
246 Eastern Boulevard North
Hagerstown, Maryland 21740
?
mi
from
Hagerstown, MD
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77025
?
mi
from
Houston, TX
Click here to add this to my saved trials
7677 Center Avenue
Huntington Beach, California 92647
?
mi
from
Huntington Beach, CA
Click here to add this to my saved trials
Indianapolis, Indiana 46290
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Lynbrook, New York 11563
?
mi
from
Lynbrook, NY
Click here to add this to my saved trials
Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
?
mi
from
Madison, WI
Click here to add this to my saved trials
Marysville, Ohio 42040
?
mi
from
Marysville, OH
Click here to add this to my saved trials
Metairie, Louisiana 70006
?
mi
from
Metairie, LA
Click here to add this to my saved trials
Minneapolis, Minnesota 55435
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Naples, Florida 34103
?
mi
from
Naples, FL
Click here to add this to my saved trials
Nashville, Tennessee 37203
?
mi
from
Nashville, TN
Click here to add this to my saved trials
400 Bayonet Street
New London, Connecticut 06320
?
mi
from
New London, CT
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
Pasadena, California 91105
?
mi
from
Pasadena, CA
Click here to add this to my saved trials
Pensacola, Florida 32503
?
mi
from
Pensacola, FL
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19107
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Poway, California 92064
?
mi
from
Poway, CA
Click here to add this to my saved trials
Reno, Nevada 89502
?
mi
from
Reno, NV
Click here to add this to my saved trials
Sacramento, California 95819
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Salt Lake City, Utah 84132
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Antonio, Texas 78240
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
1635 Divisadero Street
San Francisco, California 94143
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Santa Ana, California 92705
?
mi
from
Santa Ana, CA
Click here to add this to my saved trials
Santa Barbara, California 93103
?
mi
from
Santa Barbara, CA
Click here to add this to my saved trials
?
mi
from
Springfield, MA
Click here to add this to my saved trials
780 Route 37 West
Toms River, New Jersey 08755
?
mi
from
Toms River, NJ
Click here to add this to my saved trials
Whittier, California 90603
?
mi
from
Whittier, CA
Click here to add this to my saved trials
Willow Park, Texas 76087
?
mi
from
Willow Park, TX
Click here to add this to my saved trials
Winter Haven, Florida 33880
?
mi
from
Winter Haven, FL
Click here to add this to my saved trials