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NCT07029945

A Phase 1/2 Study of the Safety and Efficacy of BRX011 Oral Administration Once Daily in Subjects With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Not yet recruiting Phase 1, PHASE2 Last updated 26 June 2025
What this trial tests

Phase 1, PHASE2 trial testing BRX011 in Geographic Atrophy in 152 participants. Not yet recruiting.

Timeline
7 July 2025
Primary endpoint
11 November 2026
11 February 2027

Quick facts

Lead sponsorBiojiva LLC
PhasePhase 1, PHASE2
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment152
Start date7 July 2025
Primary completion11 November 2026
Estimated completion11 February 2027

Drugs / interventions tested

Conditions studied

Sponsor

Biojiva LLC — full company profile →

Who can join

55 and older, any sex, with Geographic Atrophy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aims to evaluate the safety and efficacy of BRX011, an oral medication, taken once daily by participants with geographic atrophy secondary to age-related macular degeneration. The study is conducted in phases 1 and 2, focusing on assessing both safety (tolerability) and effectiveness (efficacy) of the treatment. Participants: Adults with geographic atrophy due to age-related macular degeneration. Treatment: BRX011 or Placebo is taken once daily as per the protocol. Duration: The study involves multiple visits over 96 weeks to monitor participants' health and response to treatment. Safety Monitoring: Regular checks for adverse events and health status to ensure participant well-being. Checks will include examination of vital signs, clinical labs, ocular exams, and ocular imaging. Primary Outcome Measure: Efficacy of BRX011 in the annual rate of change in the square root of GA area, as specified in the protocol.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Oral Deuterated Docosahexaenoic Acid Protects Against Onset and Progression of RPE Degeneration in a Mouse Model of Chronic Oxidative Stress.
    Foshe S, Anderson BD, Song Y, Shi S, et al · · 2026 · PMID 41979253 · DOI 10.1167/iovs.67.4.28

Verify or expand the search:

Other recruiting trials for Geographic Atrophy

Currently open trials in the same condition.

Other Biojiva LLC trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07029945.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing