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| ID | Type | Description | Link |
|---|---|---|---|
| GX01456 | Other Identifier | Hoffmann-La Roche |
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This is a Phase Ib/II, multicenter, randomized, single-masked, sham-injection-controlled study of safety, tolerability, and evidence of activity of FCFD4514S intravitreal injections administered monthly or every other month in patients with geographic atrophy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FCFD4514S | Experimental |
| |
| sham | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FCFD4514S | Drug | Repeating intravitreal injection |
| |
| sham |
| Measure | Description | Time Frame |
|---|---|---|
| Growth rate of geographic atrophy (GA) lesion area from baseline | Month 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in best corrected visual acuity (BCVA) from baseline | Month 18 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erich Strauss, M.D. | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson | Arizona | 85704 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37314061 | Derived | Tzoumas N, Riding G, Williams MA, Steel DH. Complement inhibitors for age-related macular degeneration. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD009300. doi: 10.1002/14651858.CD009300.pub3. | |
| 29530781 | Derived | Sivaprasad S, Tschosik E, Kapre A, Varma R, Bressler NM, Kimel M, Dolan C, Silverman D. Reliability and Construct Validity of the NEI VFQ-25 in a Subset of Patients With Geographic Atrophy From the Phase 2 Mahalo Study. Am J Ophthalmol. 2018 Jun;190:1-8. doi: 10.1016/j.ajo.2018.03.006. Epub 2018 Mar 10. |
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| Drug |
Repeating sham injection |
|
| Beverly Hills |
| California |
| 90211 |
| United States |
| San Francisco | California | 94107 | United States |
| Santa Barbara | California | 93103 | United States |
| Torrance | California | 90503 | United States |
| Boynton Beach | Florida | 33426 | United States |
| Fort Lauderdale | Florida | 33334 | United States |
| Palm Beach Gardens | Florida | 33410 | United States |
| Pensacola | Florida | 32503 | United States |
| Winter Haven | Florida | 33880 | United States |
| Augusta | Georgia | 30909 | United States |
| Paducah | Kentucky | 42001 | United States |
| Baltimore | Maryland | 21287 | United States |
| Boston | Massachusetts | 02114 | United States |
| Edina | Minnesota | 55435 | United States |
| Lynbrook | New York | 11563 | United States |
| New York | New York | 10003 | United States |
| Rochester | New York | 14642 | United States |
| Charlotte | North Carolina | 28210 | United States |
| Beachwood | Ohio | 44122 | United States |
| Cincinnati | Ohio | 45242 | United States |
| Portland | Oregon | 97210 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| West Columbia | South Carolina | 29169 | United States |
| Nashville | Tennessee | 37203 | United States |
| Abilene | Texas | 79606 | United States |
| Austin | Texas | 78705 | United States |
| Dallas | Texas | 75231 | United States |
| Milwaukee | Wisconsin | 53226 | United States |
| Bonn | 53127 | Germany |
| Freiburg im Breisgau | 79106 | Germany |
| Heidelberg | 69120 | Germany |
| Leipzig | 04103 | Germany |
| Münster | 48145 | Germany |
| Tübingen | 72076 | Germany |
| 27893095 | Derived | Kimel M, Leidy NK, Tschosik E, Dolan C, Souied EH, Varma R, Bressler NM. Functional Reading Independence (FRI) Index: A New Patient-Reported Outcome Measure for Patients With Geographic Atrophy. Invest Ophthalmol Vis Sci. 2016 Nov 1;57(14):6298-6304. doi: 10.1167/iovs.16-20361. |
| 25315664 | Derived | Hariri A, Nittala MG, Sadda SR. Outer retinal tubulation as a predictor of the enlargement amount of geographic atrophy in age-related macular degeneration. Ophthalmology. 2015 Feb;122(2):407-13. doi: 10.1016/j.ophtha.2014.08.035. Epub 2014 Oct 12. |
| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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