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
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

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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