What this study is
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.
What's being tested
- BRX011
Intervention · DRUG
Subjects will ingest BRX011 orally, as capsules.
- Placebo
Intervention · DRUG
Subjects will ingest Placebo orally, as capsules.
Study details
- Sponsor
- Biojiva LLC
- Conditions
- Geographic Atrophy
- Enrolling
- 152 people
- Starts
- 2026-09-29
- Est. completion
- 2029-04
- Design
- Triple-blind, randomized, parallel groups, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 55 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (17)
17 openAssociated Retina Consultants - PHX
Gilbert, Arizona, United States
- Clinical Research Coordinator · Contact480-999-5458madison.vanzee@doctrials.com
- Stephen De Souza, MD · Principal investigator
RecruitingAssociated Retina Consultants
Phoenix, Arizona, United States
- Director of Clinical Research · Contact480-999-5458mallory.mintert@doctrials.com
- Benjamin Bakall, MD · Principal investigator
RecruitingRetina Specialists of Mississippi - Hattiesburg
Hattiesburg, Mississippi, United States
- Contact601-255-0736aard@retinams.com
- John Fitzpatrick, MD · Principal investigator
Not yet recruitingSierra Eye Associates
Reno, Nevada, United States
- Clinical Research Coordinator · Contact775-329-0286 ext. 146jvannavong@sierraeyeassociates.com
- Arshad Khanani, MD · Principal investigator
Not yet recruitingRetina Associates of Cleveland - Beachwood
Beachwood, Ohio, United States
- Clinical Research Coordinator · Contact216-831-5700jlacombe@retina-assoc.com
- Sean Platt, MD · Principal investigator
RecruitingRetina Associates of Cleveland
Cleveland, Ohio, United States
- Clinical Research Coordinator · Contact330-759-8777lrevella@retina-assoc.com
- Joseph Coney, MD · Principal investigator
Not yet recruitingRetina Associates of Cleveland - Middleburg Heights
Middleburg Heights, Ohio, United States
- Clinical Research Coordinator · Contact440-663-0022mcunningham@retina-assoc.com
- Lediana Goduni, MD · Principal investigator
Not yet recruitingRetina Research Institute of Texas
Abilene, Texas, United States
- Clinical Study Coordinator · Contact325-673-9806Deisy.Villarreal@txicr.com
- Eric Zavaleta, MD · Principal investigator
RecruitingValley Retina Institute, PA
McAllen, Texas, United States
- Clinical Research Supervisor · Contact956-631-8875 ext. 1137Alfred.halder@eyeptcare.com
- Victor Gonzalez, MD · Principal investigator
RecruitingRetina Research Center of Southern Utah
St. George, Utah, United States
- Clinical Research Coordinator · Contact435-216-7032 ext. 1000research@southernutahretina.com
- Joshua Carlson, MD · Principal investigator
Not yet recruitingSpokane Eye Clinic
Spokane, Washington, United States
- Clinical Research Coordinator · Contact509-623-9768 ext. 1668dwaidelich@spokaneeye.com
- Andrew Cheek, MD · Principal investigator
Not yet recruiting
6 sites outside the US
Eye Clinic Albury Wodonga
Albury, New South Wales, Australia
- Clinical Research Coordinator · Contact+61 26 022 4828aecresearch@alburyeye.com.au
- Alan Luckie, MD · Principal investigator
Not yet recruitingNexus Eye Care
Baulkham Hills, New South Wales, Australia
- Clinical Research Coordinator · Contact+61 2 9680 9100reception@nexuseyecare.com.au
- Gerald Liew, MD · Principal investigator
Not yet recruitingRetina & Macula Specialists
Hurstville, New South Wales, Australia
- Clinical Research Coordinator · Contact+61 02 9598 0000gmurphy@maculaspecialists.com.au
- Adrian Fung, MD · Principal investigator
Not yet recruitingSydney Eye Hospital
Sydney, New South Wales, Australia
- Clinical Research Coordinator · Contact+61 29 382 7379eleena.tran@sydney.edu.au
- Mark Gillies, MD · Principal investigator
Not yet recruitingCentre for Eye Research Australia (CERA)
East Melbourne, Victoria, Australia
- Clinical Research Coordinator · Contact+61 39 929 8076ahua@ceruleaclinicaltrials.org.au
- Robyn Guymer, MD · Principal investigator
Not yet recruitingRetina Specialists Victoria
Rowville, Victoria, Australia
- Principal Investigator · Contact+61 3 9662 3808referral@retina-doctors.net
- Robyn Troutbeck, MD · Principal investigator
Not yet recruiting
Study team
Sponsor
Biojiva LLC
Study ID BRX011-001
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.