Zimura in Subjects With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration



Status:Active, not recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:11/11/2018
Start Date:January 2016

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

A Phase 2b Randomized, Double-Masked, Controlled Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura™ (Anti-C5 Aptamer) in Subjects With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

The objectives of this study are to evaluate the safety and efficacy of intravitreous
administration of Zimura when administered in subjects with geographic atrophy (GA) secondary
to dry age-related macular degeneration (AMD).

Part 1: Approximately 66 subjects will be randomized in a 1:1:1 ratio to the following dose
groups:

- Zimura Dose Administration 1

- Zimura Dose Administration 2

- Sham Administration 1

Part 2: Approximately 135 subjects will be randomized in a 1:2:2 ratio to the following dose
groups:

- Zimura Dose Administration 3

- Zimura Dose Administration 4

- Sham Administration 2

Subjects will receive monthly intravitreal injections of Zimura or Sham for 18 months.

Inclusion Criteria:

- Subjects of either gender aged ≥ 50 years

- Diagnosis of Non-foveal GA secondary to dry AMD

Exclusion Criteria:

- Evidence of Choroidal Neovascularization (CNV)

- GA secondary to any condition other than AMD

- Any prior treatment for AMD or any prior intravitreal treatment for any indication in
either eye, except oral supplements of vitamins and minerals

- Any intraocular surgery or thermal laser within three (3) months of trial entry

- Any prior thermal laser in the macular region, regardless of indication

- Any ocular or periocular infection in the twelve (12) weeks

- Previous therapeutic radiation in the region of the study eye

- Any sign of diabetic retinopathy in either eye
We found this trial at
52
sites
1892
mi
from 98109
Willow Park, TX
Click here to add this to my saved trials
98-1079 Moanalua Road
'Aiea, Hawaii 96701
2678
mi
from 98109
'Aiea, HI
Click here to add this to my saved trials
1580
mi
from 98109
Abilene, TX
Click here to add this to my saved trials
Altamonte Springs, Florida 32701
2541
mi
from 98109
Altamonte Springs, FL
Click here to add this to my saved trials
1358
mi
from 98109
Amarillo, TX
Click here to add this to my saved trials
2187
mi
from 98109
Asheville, NC
Click here to add this to my saved trials
2299
mi
from 98109
Augusta, GA
Click here to add this to my saved trials
1775
mi
from 98109
Austin, TX
Click here to add this to my saved trials
2328
mi
from 98109
Baltimore, MD
Click here to add this to my saved trials
2485
mi
from 98109
Boston, MA
Click here to add this to my saved trials
2701
mi
from 98109
Boynton Beach, FL
Click here to add this to my saved trials
715
mi
from 98109
Campbell, CA
Click here to add this to my saved trials
Charlotte, North Carolina 28207
2283
mi
from 98109
Charlotte, NC
Click here to add this to my saved trials
2316
mi
from 98109
Chevy Chase, MD
Click here to add this to my saved trials
1967
mi
from 98109
Cincinnati, OH
Click here to add this to my saved trials
2020
mi
from 98109
Cleveland, OH
Click here to add this to my saved trials
1020
mi
from 98109
Denver, CO
Click here to add this to my saved trials
766
mi
from 98109
Fresno, CA
Click here to add this to my saved trials
976
mi
from 98109
Fullerton, CA
Click here to add this to my saved trials
1794
mi
from 98109
Grand Rapids, MI
Click here to add this to my saved trials
1661
mi
from 98109
Grapevine, TX
Click here to add this to my saved trials
885
mi
from 98109
Henderson, NV
Click here to add this to my saved trials
2238
mi
from 98109
Hickory, NC
Click here to add this to my saved trials
1890
mi
from 98109
Houston, TX
Click here to add this to my saved trials
1049
mi
from 98109
La Jolla, CA
Click here to add this to my saved trials
2406
mi
from 98109
Ladson, SC
Click here to add this to my saved trials
2164
mi
from 98109
Marietta, GA
Click here to add this to my saved trials
2603
mi
from 98109
Melbourne, FL
Click here to add this to my saved trials
Mountain View, California 94040
707
mi
from 98109
Mountain View, CA
Click here to add this to my saved trials
?
mi
from 98109
Osijek,
Click here to add this to my saved trials
2373
mi
from 98109
Philadelphia, PA
Click here to add this to my saved trials
1116
mi
from 98109
Phoenix, AZ
Click here to add this to my saved trials
147
mi
from 98109
Portland, OR
Click here to add this to my saved trials
975
mi
from 98109
Redlands, CA
Click here to add this to my saved trials
576
mi
from 98109
Reno, NV
Click here to add this to my saved trials
2348
mi
from 98109
Richmond, VA
Click here to add this to my saved trials
2161
mi
from 98109
Rochester, NY
Click here to add this to my saved trials
626
mi
from 98109
Sacramento, CA
Click here to add this to my saved trials
Saint Petersburg, Florida 33713
2527
mi
from 98109
Saint Petersburg, FL
Click here to add this to my saved trials
701
mi
from 98109
Salt Lake City, UT
Click here to add this to my saved trials
987
mi
from 98109
Santa Ana, CA
Click here to add this to my saved trials
1502
mi
from 98109
Shawnee Mission, KS
Click here to add this to my saved trials
Springfield, Massachusetts 01199
2423
mi
from 98109
Springfield, MA
Click here to add this to my saved trials
2660
mi
from 98109
Stuart, FL
Click here to add this to my saved trials
2231
mi
from 98109
Syracuse, NY
Click here to add this to my saved trials
1866
mi
from 98109
The Woodlands, TX
Click here to add this to my saved trials
1220
mi
from 98109
Tucson, AZ
Click here to add this to my saved trials
West Columbia, South Carolina 29169
2320
mi
from 98109
West Columbia, SC
Click here to add this to my saved trials
1457
mi
from 98109
West Des Moines, IA
Click here to add this to my saved trials
2141
mi
from 98109
West Mifflin, PA
Click here to add this to my saved trials
1435
mi
from 98109
Wichita, KS
Click here to add this to my saved trials
2556
mi
from 98109
Winter Haven, FL
Click here to add this to my saved trials