Recruiting
Phase 1
Phase 2

BRX011

Sponsor:

Biojiva LLC

Code:

NCT07029945

Conditions

Geographic Atrophy

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

BRX011

Placebo

Study Details

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

Study ID

NCT07029945

Start date

Sep 29, 2026

Status verified date

Sep, 2026

Completion date

Apr, 2029

Anticipated

Primary completion date

Apr, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

152 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: BRX011

placebo comparator: Safflower Oil

Interventions

BRX011

Subjects will ingest BRX011 orally, as capsules.

Placebo

Subjects will ingest Placebo orally, as capsules.

Primary outcome measure

  • Annual rate of change in the square root of GA area [ Time Frame: Baseline (Day 0) to Week 96 ]

Central Contacts and Locations

Central contacts

Locations

Associated Retina Consultants - PHX

Recruiting

Gilbert, Arizona, United States, 85020

Contacts

Clinical Research Coordinator

480-999-5458madison.vanzee@doctrials.com

Principal Investigator:

Stephen De Souza, MD

Associated Retina Consultants

Recruiting

Phoenix, Arizona, United States, 85020

Contacts

Director of Clinical Research

480-999-5458mallory.mintert@doctrials.com

Principal Investigator:

Benjamin Bakall, MD

Retina Associates of Cleveland - Beachwood

Recruiting

Beachwood, Ohio, United States, 44122

Contacts

Clinical Research Coordinator

216-831-5700jlacombe@retina-assoc.com

Principal Investigator:

Sean Platt, MD

Retina Research Institute of Texas

Recruiting

Abilene, Texas, United States, 79606

Contacts

Clinical Study Coordinator

325-673-9806Deisy.Villarreal@txicr.com

Principal Investigator:

Eric Zavaleta, MD

Valley Retina Institute, PA

Recruiting

McAllen, Texas, United States, 78503

Contacts

Clinical Research Supervisor

956-631-8875Alfred.halder@eyeptcare.com

Principal Investigator:

Victor Gonzalez, MD

More Information

Sponsor

Biojiva LLC

Last update posted

Sep 23, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Biojiva LLC on 2026-09-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.