Geographic Atrophy study: BRX011
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
What this study is testing
What is BRX011?
BRX011 is an investigational oral capsule being studied as a potential treatment for geographic atrophy caused by age-related macular degeneration.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether a new pill works well. It also checks how safe the pill is for your eyes.
- Who it's for
- You may be able to join if you are an adult with geographic atrophy.
- What's involved
- You would take a pill once a day. You would get real medicine or a pretend one by chance.
- Time commitment
- The study lasts 96 weeks with regular visits for eye checks and blood tests.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 96 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 and older
You may be able to join 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 people must be of non-child-bearing potential (WONCBP), defined as: Women who have had surgical sterilization (hysterectomy, bilateral...
You likely 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...
- 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\.
The study team makes the final eligibility decision.
Where it is enrolling
- Gilbert, Arizona, United States
- Phoenix, Arizona, United States
- Beachwood, Ohio, United States
- Abilene, Texas, United States
- McAllen, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 96 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Gilbert, Arizona, United States; Phoenix, Arizona, United States; Beachwood, Ohio, United States; Abilene, Texas, United States; McAllen, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.