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RecruitingNCT07029945BELLAVISTAUpdated Sep 23, 2026

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

A Phase 1/2 interventional study of BRX011 and Placebo in Geographic Atrophy, sponsored by Biojiva LLC. Recruiting at 17 sites in 2 countries. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Biojiva LLC · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
152
Allocation
Randomized
Ages
55 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Geographic Atrophy

Keywords

  • Geographic Atrophy
  • AMD
  • Age-Related Macular Degeneration
  • Oral
  • Oral Therapy
  • GA
03

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
152 participants (estimated)

Study arms

  • Active comparator
    BRX011

    Drug: BRX011

  • Placebo comparator
    Safflower Oil

    Drug: Placebo

Interventions

  • DrugBRX011

    Subjects will ingest BRX011 orally, as capsules.

  • DrugPlacebo

    Subjects will ingest Placebo orally, as capsules.

05

What researchers measure

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

    Time frame: Baseline (Day 0) to Week 96

Secondary outcomes

  1. Change in low luminance deficit

    Time frame: Baseline (Day 0) to Week 96

  2. Change in ETDRS BCVA

    Time frame: Baseline (Day 0) to Week 96

06

Study locations

5 of 17 sites recruiting
  • 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
    • · Contact · aard@retinams.com · 601-255-0736
    • John Fitzpatrick, MD · Principal investigator
    Not yet recruiting
  • Sierra Eye Associates
    Reno, Nevada 89502, United States
    Not yet recruiting
  • Retina Associates of Cleveland - Beachwood
    Beachwood, Ohio 44122, United States
    • Clinical Research Coordinator · Contact · jlacombe@retina-assoc.com · 216-831-5700
    • Sean Platt, MD · Principal investigator
    Recruiting
  • Retina Associates of Cleveland
    Cleveland, Ohio 44121, United States
    • Clinical Research Coordinator · Contact · lrevella@retina-assoc.com · 330-759-8777
    • Joseph Coney, MD · Principal investigator
    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
    • Clinical Research Coordinator · Contact · dwaidelich@spokaneeye.com · 509-623-9768
    • Andrew Cheek, MD · Principal investigator
    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
    • Clinical Research Coordinator · Contact · eleena.tran@sydney.edu.au · +61 29 382 7379
    • Mark Gillies, MD · Principal investigator
    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
07

Registry details

Key details

Study ID
NCT07029945
Lead sponsor
Biojiva LLC
Responsible party
Sponsor
First posted
Jun 19, 2025
Start date
Sep 29, 2026 (estimated)
Primary completion
Apr 2029 (estimated)
Completion
Apr 2029 (estimated)
Last update
Sep 23, 2026

Study contacts

Joseph Trinh
Contact
joseph@biojiva.com
714-548-1784

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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