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

Launched by BIOJIVA LLC · Jun 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new oral medication called BRX011, taken once daily, to see if it is safe and effective for adults with geographic atrophy (GA) caused by age-related macular degeneration (AMD). GA is a condition that causes gradual vision loss, and this study aims to find out if BRX011 can slow down the progression of this eye disease. The trial will last about 96 weeks, during which participants will have regular visits to check their eye health and overall well-being.

Adults aged 55 and older with a confirmed diagnosis of GA due to AMD may be eligible to join. Participants need to have a certain level of vision in the affected eye and must be willing to follow the study procedures. People with other eye diseases, recent eye surgeries, or certain treatments are not eligible. If you join, you will take either BRX011 or a placebo (a pill with no medicine) once a day and attend scheduled visits where doctors will monitor your vision, eye condition, and general health through exams and imaging tests. The study focuses on making sure the treatment is safe and checking whether it can slow the loss of vision caused by GA.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥55 years
• • 2. Visual acuity in the study eye at Screening/Baseline
• • 1. BCVA ≥35 letters using ETDRS charts (≥20/200 Snellen equivalent)
• • 2. LLD \>5 letters
• • 3. Clinical diagnosis of GA secondary to AMD. CNV in the fellow eye is permitted.
• • (5) Clarity of ocular media, adequate pupillary dilation, and fixation to permit the evaluation of the eye, as determined by the investigator
• (6) Female subjects must be of non-child-bearing potential (WONCBP), defined as:
• • (a) A woman who had surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) (b) A woman ≥ 60 years of age (c) A woman ≥ 55 and \< 60 years of age who fulfills at least one of the following: (i) A cessation of menses for at least 12 months and a folliclestimulating hormone (FSH) test confirming non-childbearing potential (refer to laboratory reference ranges for confirmatory levels) (ii) A cessation of menses for at least 24 months without FSH levels confirmed.
• • (7) Willing and able to give informed consent and to comply with the study procedures and assessments
• 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 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 Screening/Baseline
• • (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 Screening and throughout the duration of the study; intake of supplements containing Lutein, zeaxanthin and or mesozeaxanthin (e.g., Ocuvite® , PreserVision® , SYSTANE ICAPS ® or other AREDS supplements) in the past 4 weeks prior to Screening 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 Screening