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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521758-40-00 | EU Trial (CTIS) Number |
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This study is researching an experimental drug called pozelimab (called "study drug"). The study is focused on people with a condition where certain parts of the eye's retina stop working over time, which can make it harder to see. This is called geographic atrophy (GA).
The aim of the study is to see how safe and tolerable the study drug is when used as an injection in the eye.
The study is looking at several other research questions, including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental |
| |
| Part B | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pozelimab | Drug | Administered per the protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of ocular Treatment-Emergent Adverse Event (TEAEs) in the study eye | Part A | Through week 8 |
| Occurrence of ocular TEAEs in the study eye | Part B | Through week 16 |
| Occurrence of systemic TEAEs | Part A | Through week 8 |
| Occurrence of systemic TEAEs | Part B | Through week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of pozelimab in serum | Part A | Through week 8 |
| Concentrations of pozelimab in serum | Part B | Through week 16 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion/ Exclusion criteria apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Contact | 844-734-6643 | clinicaltrials@regeneron.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Retina Associates | Recruiting | Lakewood | Colorado | 80228 | United States | |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
When Regeneron has:
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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Part A will not be masked (Open label) and part B is masked
| Occurrence of Anti-Drug Antibody (ADA) to pozelimab | Part A | Through week 8 |
| Magnitude of ADA to pozelimab | Part A | Through week 8 |
| Occurrence of ADA to pozelimab | Part B | Through week 16 |
| Magnitude of ADA to pozelimab | Part B | Through week 16 |
| Ophthalmic Consultants of Boston |
| Recruiting |
| East Weymouth |
| Massachusetts |
| 02189 |
| United States |
| Austin Retina Associates | Recruiting | Austin | Texas | 78705 | United States |
| Retina Foundation of the Southwest | Recruiting | Dallas | Texas | 75231 | United States |
| Retina Consultants Texas | Recruiting | The Woodlands | Texas | 77384 | United States |
| Arensia Exploratory Medicine at the Research Institute of Clinical Medicine | Recruiting | Tbilisi | 0112 | Georgia |
| ARENSIA Clinics SRL | Recruiting | Bucharest | 011658 | Romania |
| Arensia Exploratory Medicine Clinic at Country Hospital Cluj-Napoca | Recruiting | Cluj-Napoca | 400006 | Romania |