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RECRUITING
NCT07029945
PHASE1/PHASE2

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

Sponsor: Biojiva LLC

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

55 Years - Any

Study Type

INTERVENTIONAL

Enrollment

152

Start Date

2026-09-29

Completion Date

2029-04

Last Updated

2026-09-23

Healthy Volunteers

No

Interventions

DRUG

BRX011

Subjects will ingest BRX011 orally, as capsules.

DRUG

Placebo

Subjects will ingest Placebo orally, as capsules.

Locations (17)

Associated Retina Consultants - PHX

Gilbert, Arizona, United States

Associated Retina Consultants

Phoenix, Arizona, United States

Retina Specialists of Mississippi - Hattiesburg

Hattiesburg, Mississippi, United States

Sierra Eye Associates

Reno, Nevada, United States

Retina Associates of Cleveland - Beachwood

Beachwood, Ohio, United States

Retina Associates of Cleveland

Cleveland, Ohio, United States

Retina Associates of Cleveland - Middleburg Heights

Middleburg Heights, Ohio, United States

Retina Research Institute of Texas

Abilene, Texas, United States

Valley Retina Institute, PA

McAllen, Texas, United States

Retina Research Center of Southern Utah

St. George, Utah, United States

Spokane Eye Clinic

Spokane, Washington, United States

Eye Clinic Albury Wodonga

Albury, New South Wales, Australia

Nexus Eye Care

Baulkham Hills, New South Wales, Australia

Retina & Macula Specialists

Hurstville, New South Wales, Australia

Sydney Eye Hospital

Sydney, New South Wales, Australia

Centre for Eye Research Australia (CERA)

East Melbourne, Victoria, Australia

Retina Specialists Victoria

Rowville, Victoria, Australia