RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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 • ClinicalTrials.gov ID: NCT07029945

Registry updated: 2026-09-23

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

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.

Interventions

BRX011 (Drug)
Subjects will ingest BRX011 orally, as capsules.
Placebo (Drug)
Subjects will ingest Placebo orally, as capsules.

Eligibility criteria

Inclusion Criteria: 1. Age ≥55 years 2. Visual acuity score of BCVA ≥35 letters using ETDRS charts (≥20/200 Snellen equivalent). A Lower Luminance Deficit of \>5 letters. 3. Clinical diagnosis of GA secondary to AMD. CNV in the fellow eye is permitted. 4. Clarity of ocular media, adequate pupillary dilation, and fixation to permit the evaluation of the eye, as determined by the investigator 5. Female subjects must be of non-child-bearing potential (WONCBP), defined as: Women who have had surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) and/or women ≥ 60 years of age. Also included are women ≥ 55 and \< 60 years of age who fulfill at least one of the following: a cessation of menses for at least 12 months and a folliclestimulating hormone (FSH) test confirming non-childbearing potential and/or a cessation of menses for at least 24 months without FSH levels confirmed. Exclusion Criteria: 1. GA secondary to a condition other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like plaquenil maculopathy in either eye. 2. Any history of documented or active CNV. 3. Any ocular condition other than GA secondary to AMD that may require surgery or medical intervention during the study period. 5\. History of vitrectomy surgery, submacular surgery, other surgical intervention for AMD, corneal transplant, glaucoma filtration surgery, or cataract surgery within 3 months prior to First Treatment Visit (Randomization). 6\. History of intravitreal injection of anti-vascular endothelial growth factor (VEGF) therapies in the study eye at any time, history of intravitreal injection of any agent (e.g., triamcinolone) in the study eye within the last 3 months prior to study enrollment. A single intraoperative administration of a corticosteroid during cataract surgery at least 3 months prior to Screening is permitted. 7\. History of laser therapy in the macular region in the study eye, prior treatment with photobiomodulation, external-beam radiation therapy or transpupillary thermotherapy in study eye. 8\. Previous cell-based intraocular treatment in the study eye or previous expression vector-mediated intraocular treatments in either eye (i.e., gene therapy), any previous treatment with any deuterated molecules for eye diseases (e.g., deuterated vitamin A). 9\. History of idiopathic or autoimmune-associated uveitis, ocular or intraocular conditions, and infectious or inflammatory ocular disease. Active uveitis and infectious conjunctivitis, keratitis, scleritis or endophthalmitis. 11\. Active malignancy within the previous 12 months except for appropriately treated carcinoma in situ of cervix, resolved non-melanoma skin carcinoma, and prostate cancer with a Gleason score of less than or equal to (≤) 6, and a stable prostate-specific antigen for greater than or equal to (≥) 12 months. 13\. Intake of omega-3 supplements (e.g., fish oil, cod liver oil, krill oil, edible algae oil, flax oil) or prescription omega-3 drugs (e.g., Lovaza® , Vascepa® , Epanova® ) in the past 4 weeks prior to First Treatment Visit (Randomization) and throughout the duration of the study. 14\. Participation in an interventional clinical study within the past 30 days of Screening, or interventional GA studies within the past 5 months prior to Screening. 15\. Treatment with SYFOVRE® or IZERVAY® within 3 months prior to First Treatment Visit (Randomization) and throughout participation in the trial. Patients who initiate any other GA treatment during the study must be discontinued.

Conditions

Geographic Atrophy

Locations

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

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment