assignment
Recruiting

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

location_city
2
research sites
public
1
country
medical_information
1
disease
person_search
2
investigators

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

Please provide the source data containing the details of the experimental and non-experimental medications, including their names, dosages, routes of administration, and frequencies. Without the source data, a description of the treatments cannot be generated.

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 RomaniaRecruiting30 Mar 202616

Sites & Investigators

Conditions Studied in This Trial