Geographic AtrophyPhase 1/2BELLAVISTANCT07029945
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 study testing BRX011 in people with Geographic Atrophy, run by Biojiva LLC at 17 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Geographic Atrophy
- What is being tested?
- BRX011
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 29 Sep 2026to Apr 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
17 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
17 sites in 2 countries
United States11 sites, 11 recruiting
- Recruiting
Retina Research Institute of Texas
Abilene, Texas, 79606
Clinical Study Coordinator, 325-673-9806, Deisy.Villarreal@txicr.com
Eric Zavaleta, MD
- Recruiting
Retina Associates of Cleveland - Beachwood
Beachwood, Ohio, 44122
Clinical Research Coordinator, 216-831-5700, jlacombe@retina-assoc.com
Sean Platt, MD
- Not yet recruiting
Retina Associates of Cleveland
Cleveland, Ohio, 44121
Clinical Research Coordinator, 330-759-8777, lrevella@retina-assoc.com
Joseph Coney, MD
- Recruiting
Associated Retina Consultants - PHX
Gilbert, Arizona, 85020
Clinical Research Coordinator, 480-999-5458, madison.vanzee@doctrials.com
Stephen De Souza, MD
- Not yet recruiting
Retina Specialists of Mississippi - Hattiesburg
Hattiesburg, Mississippi, 39402
601-255-0736, aard@retinams.com
John Fitzpatrick, MD
- Recruiting
Valley Retina Institute, PA
McAllen, Texas, 78503
Clinical Research Supervisor, 956-631-8875 ext. 1137, Alfred.halder@eyeptcare.com
Victor Gonzalez, MD
- Not yet recruiting
Retina Associates of Cleveland - Middleburg Heights
Middleburg Heights, Ohio, 44130
Clinical Research Coordinator, 440-663-0022, mcunningham@retina-assoc.com
Lediana Goduni, MD
- Recruiting
Associated Retina Consultants
Phoenix, Arizona, 85020
Director of Clinical Research, 480-999-5458, mallory.mintert@doctrials.com
Benjamin Bakall, MD
- Not yet recruiting
Sierra Eye Associates
Reno, Nevada, 89502
Clinical Research Coordinator, 775-329-0286 ext. 146, jvannavong@sierraeyeassociates.com
Arshad Khanani, MD
- Not yet recruiting
Spokane Eye Clinic
Spokane, Washington, 99204
Clinical Research Coordinator, 509-623-9768 ext. 1668, dwaidelich@spokaneeye.com
Andrew Cheek, MD
- Not yet recruiting
Retina Research Center of Southern Utah
St. George, Utah, 84790
Clinical Research Coordinator, 435-216-7032 ext. 1000, research@southernutahretina.com
Joshua Carlson, MD
Australia6 sites, 6 recruiting
- Not yet recruiting
Eye Clinic Albury Wodonga
Albury, New South Wales, 2640
Clinical Research Coordinator, +61 26 022 4828, aecresearch@alburyeye.com.au
Alan Luckie, MD
- Not yet recruiting
Nexus Eye Care
Baulkham Hills, New South Wales, 2153
Clinical Research Coordinator, +61 2 9680 9100, reception@nexuseyecare.com.au
Gerald Liew, MD
- Not yet recruiting
Centre for Eye Research Australia (CERA)
East Melbourne, Victoria, 3002
Clinical Research Coordinator, +61 39 929 8076, ahua@ceruleaclinicaltrials.org.au
Robyn Guymer, MD
- Not yet recruiting
Retina & Macula Specialists
Hurstville, New South Wales, 2220
Clinical Research Coordinator, +61 02 9598 0000, gmurphy@maculaspecialists.com.au
Adrian Fung, MD
- Not yet recruiting
Retina Specialists Victoria
Rowville, Victoria, 3178
Principal Investigator, +61 3 9662 3808, referral@retina-doctors.net
Robyn Troutbeck, MD
- Not yet recruiting
Sydney Eye Hospital
Sydney, New South Wales, 2000
Clinical Research Coordinator, +61 29 382 7379, eleena.tran@sydney.edu.au
Mark Gillies, MD
About this study
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.
Read more
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
- Being tested
- BRX011, Placebo
- Keywords
- Geographic Atrophy, AMD, Age-Related Macular Degeneration, Oral, Oral Therapy, GA
- Medical subject headings
- Geographic Atrophy, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRX011Drug
Subjects will ingest BRX011 orally, as capsules.
PlaceboDrug
Subjects will ingest Placebo orally, as capsules.
| Study group | Role | What they receive |
|---|---|---|
| BRX011 | Active comparator | Not described Receives: Drug: BRX011 |
| Safflower Oil | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (Day 0) to Week 96
Secondary outcomes (2)
Change in low luminance deficit
Measured: Baseline (Day 0) to Week 96
Change in ETDRS BCVA
Measured: Baseline (Day 0) to Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start29 Sep 2026 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geographic AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biojiva LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029945
- Sponsor's protocol ID
- BRX011-001
- Acronym
- BELLAVISTA
- Status last verified
- Sep 2026
- First submitted
- 12 Jun 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07029945
- Acronym / sponsor ID
- BELLAVISTA / BRX011-001
- Conditions
- Geographic Atrophy
- Keywords
- Geographic Atrophy, AMD, Age-Related Macular Degeneration, Oral, Oral Therapy, GA
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Biojiva LLCIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2026 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BRX011 | Active comparator | Drug: BRX011 |
| Safflower Oil | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BRX011Subjects will ingest BRX011 orally, as capsules. | Drug | BRX011 |
| PlaceboSubjects will ingest Placebo orally, as capsules. | Drug | Safflower Oil |
Primary outcome
Annual rate of change in the square root of GA area
Time frame: Baseline (Day 0) to Week 96
Annual rate of change in the square root of GA area assessed by FAF
2 secondary outcomes
Change in low luminance deficit
Time frame: Baseline (Day 0) to Week 96
Change in ETDRS BCVA
Time frame: Baseline (Day 0) to Week 96
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BRX011 in people with Geographic Atrophy, run by Biojiva LLC at 17 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph Trinh (714-548-1784, joseph@biojiva.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual rate of change in the square root of GA area (time frame: Baseline (Day 0) to Week 96). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.