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

NCT07029945 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: BRX011-001
• Study Type: interventional
• Target: 152
• Locations: 2 countries
• Sites: 17

Brief 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.

Conditions

Geographic Atrophy

Keywords

Geographic Atrophy; AMD; Age-Related Macular Degeneration; Oral; Oral Therapy; GA

Outcome Measures

Primary Outcomes (1)

• Annual rate of change in the square root of GA area

  Annual rate of change in the square root of GA area assessed by FAF

  Baseline (Day 0) to Week 96

Secondary Outcomes (2)

• Change in low luminance deficit

  Baseline (Day 0) to Week 96

• Change in ETDRS BCVA

  Baseline (Day 0) to Week 96

Study Arms (2)

BRX011

ACTIVE COMPARATOR

Drug: BRX011

Safflower Oil

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BRX011 DRUG

Subjects will ingest BRX011 orally, as capsules.

BRX011

Placebo DRUG

Subjects will ingest Placebo orally, as capsules.

Safflower Oil

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥55 years
• Visual acuity score of BCVA ≥35 letters using ETDRS charts (≥20/200 Snellen equivalent). A Lower Luminance Deficit of \>5 letters.
• Clinical diagnosis of GA secondary to AMD. CNV in the fellow eye is permitted.
• Clarity of ocular media, adequate pupillary dilation, and fixation to permit the evaluation of the eye, as determined by the investigator
• 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.

You may not qualify if:

• GA secondary to a condition other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like plaquenil maculopathy in either eye.
• Any history of documented or active CNV.
• Any ocular condition other than GA secondary to AMD that may require surgery or medical intervention during the study period.
• \. 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).
• \. 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.
• \. 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.
• \. 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).
• \. 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.
• \. 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.
• \. 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.
• \. 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.
• \. 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.

Sponsors & Collaborators

• Biojiva LLC: lead

Study Sites (17)

Associated Retina Consultants - PHX

Gilbert, Arizona, 85020, United States

RECRUITING

Associated Retina Consultants

Phoenix, Arizona, 85020, United States

RECRUITING

Retina Specialists of Mississippi - Hattiesburg

Hattiesburg, Mississippi, 39402, United States

NOT YET RECRUITING

Sierra Eye Associates

Reno, Nevada, 89502, United States

NOT YET RECRUITING

Retina Associates of Cleveland - Beachwood

Beachwood, Ohio, 44122, United States

RECRUITING

Retina Associates of Cleveland

Cleveland, Ohio, 44121, United States

NOT YET RECRUITING

Retina Associates of Cleveland - Middleburg Heights

Middleburg Heights, Ohio, 44130, United States

NOT YET RECRUITING

Retina Research Institute of Texas

Abilene, Texas, 79606, United States

RECRUITING

Valley Retina Institute, PA

McAllen, Texas, 78503, United States

RECRUITING

Retina Research Center of Southern Utah

St. George, Utah, 84790, United States

NOT YET RECRUITING

Spokane Eye Clinic

Spokane, Washington, 99204, United States

NOT YET RECRUITING

Eye Clinic Albury Wodonga

Albury, New South Wales, 2640, Australia

NOT YET RECRUITING

Nexus Eye Care

Baulkham Hills, New South Wales, 2153, Australia

NOT YET RECRUITING

Retina & Macula Specialists

Hurstville, New South Wales, 2220, Australia

NOT YET RECRUITING

Sydney Eye Hospital

Sydney, New South Wales, 2000, Australia

NOT YET RECRUITING

Centre for Eye Research Australia (CERA)

East Melbourne, Victoria, 3002, Australia

NOT YET RECRUITING

Retina Specialists Victoria

Rowville, Victoria, 3178, Australia

NOT YET RECRUITING

MeSH Terms

Conditions

Geographic Atrophy; Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Central Study Contacts

Joseph Trinh

CONTACT

714-548-1784; joseph@biojiva.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 19, 2025
• Study Start: September 29, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: September 23, 2026

Record last verified: 2026-09

Locations

US (11); AU (6)