Clinical trial • Phase I • Ophthalmology
Pozelimab for Geographic atrophy
Phase I trial of Pozelimab for Geographic atrophy. 38 participants.
Overview
- Trial Therapeutic Area
- Ophthalmology
- Trial Disease
- Geographic atrophy
- Trial Stage
- Phase I
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 11-11-2025
- First CTIS Authorization Date
- 23-03-2026
Trial design
Phase I trial across 2 sites in Romania.
- Target Sample Size
- 38
Eligibility
Recruits 38 Vulnerable population selected; no further details on consent or assent handling provided in the record..
- Vulnerable Population
- Vulnerable population selected; no further details on consent or assent handling provided in the record.
Recruitment
- Planned Sample Size
- 38
- Recruitment Window Months
- 28
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 38
Romania
- Earliest CTIS Part Ii Submission Date
- 09-03-2026
- Latest Decision Or Authorization Date
- 23-03-2026
- Processing Time Days
- 14
- Number Of Sites
- 2
- Number Of Participants
- 16
Sites
- Site Name
- Arensia Clinics S.R.L.
- Department Name
- AEM in colab. with Arensia Clinics, 3rd floor, Wrds 1,2,3,4,5,6,7,Tudor Stefan Str,Bucharest
- Contact Person Name
- Ruxandra Simionescu
- Contact Person Email
- ruxandra.simionescu.ext@arensia-em.com
- Site Name
- Spitalul Clinic Judetean De Urgenta Cluj
- Department Name
- AEM with County Hosp. Cluj Napoca, Ophtalm. Build. 1st floor, Wrds 33,34,35, Clinicilor St
- Contact Person Name
- Simona Nicoara
- Contact Person Email
- simona.nicoara.ext@arensia-em.com
Sponsor
Primary sponsor
- Full Name
- Regeneron Pharmaceuticals Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- Pozelimab
- Active Substance
- Pozelimab
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravitreal (IVT)
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