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NCT07029945PHASE1, PHASE2Recruiting

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

Biojiva LLC

Start Date

9/29/2026

Completion Date

4/1/2029

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.

Eligibility Criteria

Age Range: 55 years to No maximum

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.

Interventions

DRUG

BRX011

DRUG

Placebo

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Conditions

Geographic Atrophy

Locations

Associated Retina Consultants - PHX

Gilbert, Arizona 85020

United States

Associated Retina Consultants

Phoenix, Arizona 85020

United States

Retina Specialists of Mississippi - Hattiesburg

Hattiesburg, Mississippi 39402

United States

Sierra Eye Associates

Reno, Nevada 89502

United States

Retina Associates of Cleveland - Beachwood

Beachwood, Ohio 44122

United States

Retina Associates of Cleveland

Cleveland, Ohio 44121

United States

Retina Associates of Cleveland - Middleburg Heights

Middleburg Heights, Ohio 44130

United States

Retina Research Institute of Texas

Abilene, Texas 79606

United States

Valley Retina Institute, PA

McAllen, Texas 78503

United States

Retina Research Center of Southern Utah

St. George, Utah 84790

United States

Spokane Eye Clinic

Spokane, Washington 99204

United States

Eye Clinic Albury Wodonga

Albury, New South Wales 2640

Australia

Nexus Eye Care

Baulkham Hills, New South Wales 2153

Australia

Retina & Macula Specialists

Hurstville, New South Wales 2220

Australia

Sydney Eye Hospital

Sydney, New South Wales 2000

Australia

Centre for Eye Research Australia (CERA)

East Melbourne, Victoria 3002

Australia

Retina Specialists Victoria

Rowville, Victoria 3178

Australia