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
Springfield, Massachusetts 01199
1364
mi
from
Springfield, MA
Click here to add this to my saved trials
98-1079 Moanalua Road
'Aiea, Hawaii 96701
3719
mi
from
'Aiea, HI
Click here to add this to my saved trials
381
mi
from
Abilene, TX
Click here to add this to my saved trials
Altamonte Springs, Florida 32701
1136
mi
from
Altamonte Springs, FL
Click here to add this to my saved trials
283
mi
from
Amarillo, TX
Click here to add this to my saved trials
858
mi
from
Asheville, NC
Click here to add this to my saved trials
932
mi
from
Augusta, GA
Click here to add this to my saved trials
522
mi
from
Austin, TX
Click here to add this to my saved trials
1148
mi
from
Baltimore, MD
Click here to add this to my saved trials
1444
mi
from
Boston, MA
Click here to add this to my saved trials
1292
mi
from
Boynton Beach, FL
Click here to add this to my saved trials
1318
mi
from
Campbell, CA
Click here to add this to my saved trials
Charlotte, North Carolina 28207
959
mi
from
Charlotte, NC
Click here to add this to my saved trials
1123
mi
from
Chevy Chase, MD
Click here to add this to my saved trials
726
mi
from
Cincinnati, OH
Click here to add this to my saved trials
895
mi
from
Cleveland, OH
Click here to add this to my saved trials
409
mi
from
Denver, CO
Click here to add this to my saved trials
1210
mi
from
Fresno, CA
Click here to add this to my saved trials
1153
mi
from
Fullerton, CA
Click here to add this to my saved trials
733
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
335
mi
from
Grapevine, TX
Click here to add this to my saved trials
954
mi
from
Henderson, NV
Click here to add this to my saved trials
921
mi
from
Hickory, NC
Click here to add this to my saved trials
569
mi
from
Houston, TX
Click here to add this to my saved trials
1118
mi
from
La Jolla, CA
Click here to add this to my saved trials
1048
mi
from
Ladson, SC
Click here to add this to my saved trials
788
mi
from
Marietta, GA
Click here to add this to my saved trials
1198
mi
from
Melbourne, FL
Click here to add this to my saved trials
Mountain View, California 94040
1325
mi
from
Mountain View, CA
Click here to add this to my saved trials
?
mi
from
Osijek,
Click here to add this to my saved trials
1225
mi
from
Philadelphia, PA
Click here to add this to my saved trials
853
mi
from
Phoenix, AZ
Click here to add this to my saved trials
1383
mi
from
Portland, OR
Click here to add this to my saved trials
1110
mi
from
Redlands, CA
Click here to add this to my saved trials
1188
mi
from
Reno, NV
Click here to add this to my saved trials
1111
mi
from
Richmond, VA
Click here to add this to my saved trials
1122
mi
from
Rochester, NY
Click here to add this to my saved trials
1278
mi
from
Sacramento, CA
Click here to add this to my saved trials
Saint Petersburg, Florida 33713
1117
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
779
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
1154
mi
from
Santa Ana, CA
Click here to add this to my saved trials
190
mi
from
Shawnee Mission, KS
Click here to add this to my saved trials
1253
mi
from
Stuart, FL
Click here to add this to my saved trials
1193
mi
from
Syracuse, NY
Click here to add this to my saved trials
541
mi
from
The Woodlands, TX
Click here to add this to my saved trials
833
mi
from
Tucson, AZ
Click here to add this to my saved trials
West Columbia, South Carolina 29169
971
mi
from
West Columbia, SC
Click here to add this to my saved trials
340
mi
from
West Des Moines, IA
Click here to add this to my saved trials
978
mi
from
West Mifflin, PA
Click here to add this to my saved trials
27
mi
from
Wichita, KS
Click here to add this to my saved trials
574
mi
from
Willow Park, TX
Click here to add this to my saved trials
1148
mi
from
Winter Haven, FL
Click here to add this to my saved trials