152 Participants NeededMy employer runs this trial

BRX011 for Age-Related Macular Degeneration

(BELLAVISTA Trial)

Recruiting at 16 trial locations
JT
Overseen ByJoseph Trinh
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Biojiva LLC

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults aged 55 or older with geographic atrophy caused by age-related macular degeneration. Participants must have a certain level of vision, clear eye structures for exams, and be able to follow study procedures. Women must not be able to become pregnant.

Inclusion Criteria

I am willing and able to follow the study's procedures and assessments.
I have measurable vision in my study eye at screening.
My vision loss is more than 5 letters on the eye chart.
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What Are the Treatments Tested in This Trial?

Interventions

  • BRX011

Trial Overview

The study tests BRX011, an oral medication taken once daily, compared to a placebo in people with geographic atrophy from macular degeneration. The goal is to see if BRX011 slows disease progression over about two years.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: BRX011Active Control1 Intervention
Group II: Safflower OilPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Biojiva LLC

Lead Sponsor