Daily BRX011 pill for geographic atrophy due to AMD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a combined Phase 1/2 trial evaluating BRX011 versus placebo in adults with geographic atrophy from AMD. Participants take BRX011 or placebo once daily for up to 96 weeks while researchers monitor safety and changes in the disease. The study includes regular eye exams, imaging, and general health checks to assess tolerability and efficacy, focusing on the rate of GA area change. Primary outcome is the annual change in the square root of GA area to gauge progression. The trial progresses through early safety assessment and later efficacy assessment in a controlled setting.

Why it matters

Who can join: the full rules

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.

Where it's running

• Associated Retina Consultants - PHX
  Gilbert, Arizona, United States Recruiting
• Associated Retina Consultants
  Phoenix, Arizona, United States Recruiting
• Retina Associates of Cleveland - Beachwood
  Beachwood, Ohio, United States Recruiting
• Retina Research Institute of Texas
  Abilene, Texas, United States Recruiting
• Valley Retina Institute, PA
  McAllen, Texas, United States Recruiting
• Retina Specialists of Mississippi - Hattiesburg
  Hattiesburg, Mississippi, United States Not yet recruiting

Study contacts

• Study coordinator: Joseph Trinh
• Email: joseph@biojiva.com
• Phone: 714-548-1784

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Central microperimetry and radial OCT in geographic atrophy

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• Eye injections of ABBV-6628 for geographic atrophy from age-related macular degeneration

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.