Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2025-12-24 @ 5:01 PM
NCT ID:
NCT03488550
Brief Summary:
This is a multi center, open-label, single dose, safety study. Approximately 9 to 15 participants with open-angle glaucoma are assigned into 3 sequential dose-levels and will receive ANX007 administered as single, IVT injections.
Detailed Description:
This is a phase 1, open-label, dose-escalation, safety study evaluating up to 3 dose levels of ANX007 administered as single IVT injections. Approximately 9 to 15 eligible participants are enrolled into one cohort each. All participants receive ANX007 in an open-label manner. The primary objective is to evaluate the safety and tolerability of a single intravitreal (IVT) injection of ANX007 in participants with primary open-angle glaucoma. Secondary objectives are to evaluate the serum pharmacokinetics (PK) and immunogenicity. An exploratory objective will evaluate the pharmacodynamic (PD) effect of ANX007 on serum C1q activity.
Study:
NCT03488550
Study Brief:
Protocol Section:
NCT03488550