A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Pozelimab in Adult Patients with Geographic Atrophy
- Trial ID
- 2025-521758-40-00
- Protocol
- R3918-AMD-2501
Trial statistics
Diseases & Conditions
Objectives
The primary objective is to evaluate the efficacy of intravitreal pozelimab in patients with geographic atrophy. This assessment is clinically significant for determining the potential of the investigational product to mitigate the progression of retinal degeneration associated with this condition.
Participants
The study involves a total of 38 patients diagnosed with geographic atrophy. The population includes both males and females within the age ranges corresponding to 3 and 4 years. The sponsor did not provide additional information regarding lifestyle considerations, selection processes, or specific inclusion and exclusion criteria.
Plans and Procedures
This Phase 1 clinical trial is designed to evaluate the efficacy and safety of intravitreal pozelimab in adult participants diagnosed with geographic atrophy. The study utilizes a controlled methodology to assess the therapeutic impact of the investigational product. The research sequence begins with a screening visit to determine eligibility based on predefined criteria. Following successful enrollment, participants will undergo scheduled follow-up visits to monitor clinical progression and safety parameters. The protocol concludes with an end-of-study visit. The total duration of participant involvement is determined by the clinical monitoring schedule. Early termination of participation may occur based on specific safety protocols or clinical criteria established within the study design.
Treatment
Efficacy
The assessment of efficacy in this study involving patients with geographic atrophy remains to be determined by the specific clinical parameters established within the protocol.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
Romania | Recruiting | 30 Mar 2026 | 16 |

