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Clinical Trials in the USA / NCT07029945
Recruiting Phase 1/2

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

NCT07029945 · tracked via the Priya Life Science USA tracker
Sponsor
Biojiva LLC
Phase
Phase 1/2
Started
2026-09-29
Last updated
2026-09-23

Condition(s) studied

Geographic Atrophy

Investigational drug(s) / intervention(s)

BRX011Placebo

BRX011: Subjects will ingest BRX011 orally, as capsules.

Placebo: Subjects will ingest Placebo orally, as capsules.

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.

Eligibility

Sex
ALL
Min age
55 Years
Max age
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: 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.

Primary outcome measure(s)

Trial sites (17)

FacilityCityRegionStatus
Associated Retina Consultants - PHX Gilbert Arizona Recruiting
Associated Retina Consultants Phoenix Arizona Recruiting
Retina Specialists of Mississippi - Hattiesburg Hattiesburg Mississippi Not Yet Recruiting
Sierra Eye Associates Reno Nevada Not Yet Recruiting
Retina Associates of Cleveland - Beachwood Beachwood Ohio Recruiting
Retina Associates of Cleveland Cleveland Ohio Not Yet Recruiting
Retina Associates of Cleveland - Middleburg Heights Middleburg Heights Ohio Not Yet Recruiting
Retina Research Institute of Texas Abilene Texas Recruiting
Valley Retina Institute, PA McAllen Texas Recruiting
Retina Research Center of Southern Utah St. George Utah Not Yet Recruiting
Spokane Eye Clinic Spokane Washington Not Yet Recruiting
Eye Clinic Albury Wodonga Albury New South Wales Not Yet Recruiting
Nexus Eye Care Baulkham Hills New South Wales Not Yet Recruiting
Retina & Macula Specialists Hurstville New South Wales Not Yet Recruiting
Sydney Eye Hospital Sydney New South Wales Not Yet Recruiting
Centre for Eye Research Australia (CERA) East Melbourne Victoria Not Yet Recruiting
Retina Specialists Victoria Rowville Victoria Not Yet Recruiting

More Biojiva LLC trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07029945 on ClinicalTrials.gov ↗ ← All trials in the USA