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Phase 2 study is designed to assess the efficacy of ADX-038 compared with placebo in participants with GA secondary to AMD. Safety, pharmacokinetics (PK), and pharmacodynamics (PD) will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active - ADX-038 | Experimental |
| |
| Placebo - Saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADX-038 | Drug | siRNA duplex oligonucleotide |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effect of ADX-038 on the preservation of the EZ layer | Rate of change in the area of total EZ loss in the study eye from baseline to Month 12 | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nali Castillo | Contact | 877-232-7974 | info@adarx.com |
| Name | Affiliation | Role |
|---|---|---|
| Aditya Patel, MD | ADARx Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ADARx Clinical Site | Recruiting | Gilbert | Arizona | 85297 | United States | |
| ADARx Clinical Site |
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Randomized, Masked, Placebo-Controlled
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| Placebo | Drug | Saline |
|
| Recruiting |
| Phoenix |
| Arizona |
| 85020 |
| United States |
| ADARx Clinical Site | Recruiting | Bakersfield | California | 93309 | United States |
| ADARx Clinical Site | Recruiting | Beverly Hills | California | 90211 | United States |
| ADARx Clinical Site | Recruiting | Huntington Beach | California | 93647 | United States |
| ADARx Clinical Site | Recruiting | Poway | California | 92064 | United States |
| ADARx Clinical Site | Recruiting | Orlando | Florida | 32806 | United States |
| ADARx Clinical Site | Recruiting | Wildwood | Florida | 34785 | United States |
| ADARx Clinical Site | Recruiting | Hagerstown | Maryland | 21740 | United States |
| ADARx Clinical Site | Recruiting | Reno | Nevada | 89502 | United States |
| ADARx Clinical Site | Withdrawn | Erie | Pennsylvania | 16505 | United States |
| ADARx Clinical Site | Recruiting | Austin | Texas | 78705 | United States |
| ADARx Clinical Site | Recruiting | Bellaire | Texas | 77401 | United States |
| ADARx Clinical Site | Recruiting | Dallas | Texas | 75231 | United States |
| ADARx Clinical Site | Recruiting | McAllen | Texas | 78503 | United States |
| ADARx Clinical Site | Recruiting | Round Rock | Texas | 78681 | United States |
| ADARx Clinical Site | Recruiting | San Antonio | Texas | 78340 | United States |
| ADARx Clinical Site | Recruiting | The Woodlands | Texas | 77384 | United States |
| ADARx Clinical Site | Recruiting | St. George | Utah | 84790 | United States |
| ADARx Clinical Site | Recruiting | Albury | New South Wales | 2640 | Australia |
| ADARx Clinical Site | Recruiting | Hurstville | New South Wales | 2220 | Australia |
| ADARx Clinical Site | Recruiting | Parramatta | New South Wales | 2150 | Australia |
| ADARx Clinical Site | Recruiting | East Melbourne | Victoria | 3002 | Australia |
| ADARx Clinical Site | Recruiting | Rowville | Victoria | 3178 | Australia |
| ADARx Clinical Site | Recruiting | Vancouver | British Columbia | Canada |
| ADARx Clinical Site | Recruiting | Ottawa | Ontario | K2B 7E9 | Canada |
| ADARx Clinical Site | Recruiting | Toronto | Ontario | M8X 2X3 | Canada |
| ID | Term |
|---|---|
| D034741 | RNA, Small Interfering |
| ID | Term |
|---|---|
| D016372 | RNA, Antisense |
| D016375 | Antisense Elements (Genetics) |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012313 | RNA |
| D009696 | Nucleic Acids |
| D058727 | RNA, Small Untranslated |
| D022661 | RNA, Untranslated |
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