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This Phase 3, multicenter, double-masked, parallel-group, placebo-controlled, randomized, fixed-dose clinical study is designed to evaluate the efficacy and safety of tinlarebant (LBS-008) in subjects diagnosed with GA.
Subjects will be randomized in a 2:1 ratio to receive either tinlarebant or placebo. The study treatment will be administered orally once daily from baseline (Day 1) through the final day of Month 24.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LBS-008, Tinlarebant | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tinlarebant | Drug | 5 mg tablet taken orally once a day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To measure the rate of change (growth rate slope) in geographic atrophy (GA) lesion size | From baseline to Month 24] |
| Measure | Description | Time Frame |
|---|---|---|
| To measure the change in best-corrected visual acuity (BCVA) as assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) scale | From baseline to Month 24 | |
| To measure changes in the area and size of the inner/outer segment junction of photoreceptors by spectral domain optical coherence tomography (SD-OCT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Belite Study Site | Phoenix | Arizona | 85020 | United States | ||
| Belite Study Site |
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Eligible subjects will be randomly assigned to begin treatment in 2:1 ratio to receive the study drug (either Tinlarebant 5 mg or matching placebo)
| Placebo |
| Drug |
Placebo tablets for tinlarebant 5 mg prepared similarly. |
|
| From baseline to Month 24 |
| Arcadia |
| California |
| 91007 |
| United States |
| Belite Study Site | Beverly Hills | California | 90211 | United States |
| Belite Study Site | Huntington Beach | California | 92467 | United States |
| Belite Study Site | Los Angeles | California | 90033 | United States |
| Belite Study Site | Palo Alto | California | 94303 | United States |
| Belite Study Site | San Diego | California | 92093 | United States |
| Belite Study Site | Lakeland | Florida | 33805 | United States |
| Belite Study Site | Hagerstown | Maryland | 21740 | United States |
| Belite Study Site | Saint Louis Park | Minnesota | 55416 | United States |
| Belite Study Site | Westbury | New York | 11590 | United States |
| Belite Study Site | Cary | North Carolina | 27511 | United States |
| Belite Study Site | Durham | North Carolina | 27710 | United States |
| Belite Study Site | Wake Forest | North Carolina | 27587 | United States |
| Belite Study Site | Portland | Oregon | 97239 | United States |
| Belite Study Site | Philadelphia | Pennsylvania | 19107 | United States |
| Belite Study Site | Sewickley | Pennsylvania | 15143 | United States |
| Belite Study Site | Germantown | Tennessee | 38138 | United States |
| Belite Study Site | Abilene | Texas | 79606 | United States |
| Belite Study Site | Dallas | Texas | 75231 | United States |
| Belite Study Site | San Antonio | Texas | 78240 | United States |
| Belite Study Site | Warrenton | Virginia | 20186 | United States |
| Belite Study Site | Chatswood | New South Wales | 2067 | Australia |
| Belite Study Site | Strathfield | New South Wales | 2135 | Australia |
| Belite Study Site | Brisbane | Queensland | 4101 | Australia |
| Belite Study Site | Adelaide | South Australia | 5000 | Australia |
| Belite Study Site | East Melbourne | Victoria | 3002 | Australia |
| Belite Study Site | Crawley | Western Australia | 6009 | Australia |
| Belite Study Site | Beijing | Beijing Municipality | 100044 | China |
| Belite Study Site | Chengdu | Sichuan | 610093 | China |
| Belite Study Site | Beijing | 10005 | China |
| Belite Study Site | Beijing | 100730 | China |
| Belite Study Site | Guandong | 510060 | China |
| Belite Study Site | Zhejiang | 325027 | China |
| Belite Study Site | Ostrava | 70852 | Czechia |
| Belite Study Site | Prague | 14000 | Czechia |
| Belite Study Site | Prague | 14059 | Czechia |
| Belite Study Site | Dijon | 21000 | France |
| Belite Study Site | Écully | 69130 | France |
| Belite Study Site | Lyon | 69317 | France |
| Belite Study Site | Marseille | 130008 | France |
| Belite Study Site | Basel | 4031 | Switzerland |
| Belite Study Site | Lausanne | 1001 | Switzerland |
| Belite Study Site | Taichung | 40447 | Taiwan |
| Belite Study Site | Taipei | 100 | Taiwan |
| Belite Study Site | Taoyuan | 33305 | Taiwan |
| Belite Study Site | Great Yarmouth | NR31 6LA | United Kingdom |
| Belite Study Site | Harrow | HA1 3UJ | United Kingdom |
| Belite Study Site | London | EC1V 2PD | United Kingdom |
| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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